MALTITOL
UNII D65DG142WK

Substance Identification & Data

This profile provides standardized clinical and technical data for Maltitol, uniquely identified by the FDA Unique Ingredient Identifier (UNII) D65DG142WK.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 585-88-6 and the RxNorm Concept ID (RxCUI) 1363049. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
D65DG142WK
CAS Registry Number
585-88-6
RxNorm Concept ID
1363049

Detailed Substance Profile

Preferred Name
MALTITOL
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
D65DG142WK
The specific atomic composition represented as a molecular structure string.
InChIKey
C12H24O11
International Chemical Identifier digital signature for unique molecular identification.
SMILES String
VQHSOMBJVWLPSR-WUJBLJFYSA-N
Line notation for describing the chemical structure and connectivity of atoms.
NCI Thesaurus
C77138
National Cancer Institute reference terminology for clinical and research data.
PubChem CID
493591
Unique identification number in the NCBI database of chemical substances.
Substance Type
chemical
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
Ingredient Role
[C@H]1([C@@H]([C@@H](O)[C@@H]([C@H](O1)CO)O)O)O[C@@]([C@@H]([C@@H](O)CO)O)([C@H](O)CO)[H]

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Maltitol. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

FDA Official Name

MALTITOL

Common Names & Synonyms

AMALTY MR 100
CERESTAR 16303
DRIED MALTITOL SYRUP
HYDROGENATED HIGH MALTOSE-CONTENT GLUCOSE SYRUP
HYDROGENATED MALTOSE
LYCASIN HBC
MALBIT CH 16385
MALTIDEX CH 16385
MALTISWEET 3145
MALTITOL [EP MONOGRAPH]
MALTITOL [FCC]
MALTITOL [II]
MALTITOL [MART.]
MALTITOL [USP-RS]
MALTITOL SOLUTION
MALTITOL SOLUTION [NF]
MALTITOL SYRUP POWDER
SWEETPEARL P 200

Technical Codes

E-965(I)
INS NO.965(I)
INS-965(I)

NDC Products Containing MALTITOL

This unique ingredient identifier is listed as an ingredient or substance in the following products in the NDC directory:

Manufacturer Quick Index

Note: Due to the high number of listings (371), only Active Listings are currently displayed. Display is limited to the first 200 products.
→ 7-ELEVEN 2
→ A-S Medication Solutions 1
→ AMERISOURCEBERGEN DRUG CORPORATION 1
→ ATLANTIC BIOLOGICALS CORP. 1
→ Acadia Pharmaceuticals Inc. 1
→ Actavis Pharma, Inc. 1
→ Aldi Inc 1
→ Alvogen Inc. 4
→ Amarin Pharma Inc. 3
→ American Health Packaging 1
→ Amerisource Bergen 1
→ Amneal Pharmaceuticals LLC 1
→ Aquestive Therapeutics 3
→ Army & Air Force Exchange Service 5
→ Ascend Laboratories, LLC 4
→ Atlantic Biologicals 1
→ Atlantic Biologicals Corp. 1
→ Aurobindo Pharma Limited 2
→ Aurohealth LLC 1
→ Aveva Drug Delivery Systems Inc. 4
→ Bayer HealthCare LLC. 3
→ Best Choice 1
→ Best Choice (Valu Merchandisers Company) 1
→ Better Living Brands LLC 1
→ BluePoint Laboratories 1
→ Bryant Ranch Prepack 2
→ CMP Pharma, Inc. 1
→ CVS Pharmacy, Inc. 1
→ CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1
→ Camber Pharmaceuticals, Inc. 7
→ Cardinal Health 107, LLC 2
→ Chain Drug Consortium, LLC 1
→ Chartwell RX, LLC 2
→ Chattem, Inc. 1
→ DENTAL ALLIANCE HOLDINGS LLC 2
→ DISCOUNT DRUG MART 1
→ DLC Laboratories, Inc. 1
→ Dental Alliance Holdings LLC 3
→ Discount Drug Mart 3
→ Dolgencorp Inc 2
→ Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 3
→ Dolgencorp, LLC 1
→ Dr.Reddys Laboratories Inc 4
→ E.R. Squibb & Sons, L.L.C. 1
→ EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 1
→ Family Dollar (FAMILY WELLNESS) 1
→ Family Dollar Services, Inc. 1
→ Fertin Pharma A/S 1
→ Geri-Care Pharmaceuticals, Corp 1
→ Guardian Drug Company 1
→ H E B 3
→ HY-VEE, INC 1
→ Haleon US Holdings LLC 9
→ INDIVIOR INC. 4
→ INGENUS PHARMACEUTICALS, LLC 2
→ KROGER COMPANY 1
→ KVK-Tech, Inc. 5
→ Kroger Company 2
→ L. Perrigo Company 6
→ Lundbeck Pharmaceuticals LLC 1
→ MAJOR PHARMACEUTICALS 1
→ Major Pharmaceuticals 2
→ Meijer, Inc. 1
→ Method Pharmaceuticals 1
→ Mondelez Global LLC 1
→ Mylan Pharmaceuticals Inc. 4
→ Nelson Bach USA Limited 2
→ Nelson Bach USA Ltd 6
→ NorthStar Rx LLC 1
→ NorthStar RxLLC 1
→ P & L Development, LLC 3
→ PAI Holdings, LLC dba PAI Pharma 4
→ Padagis Israel Pharmaceuticals Ltd 1
→ Pharmadel LLC 3
→ Qilu Pharmaceutical Co., Ltd. 1
→ RB Health (US) LLC 3
→ Redpharm Drug 3
→ Rite Aid 7
→ Rite Aid Corporation 1
→ Safeway, Inc. 3
→ Sun Pharmaceutical Industries, Inc. 1
→ TARGET Corporation 2
→ TOP CARE (Topco Associates LLC) 1
→ Taro Pharmaceuticals U.S.A., Inc. 1
→ The Kroger Co. 1
→ Topco Associates LLC 3
→ U.S. Pharmaceuticals 1
→ United Natural Foods, Inc. dba UNFI 1
→ Validus Pharmaceuticals LLC 1
→ WALGREEN COMPANY 1
→ Wal-Mart Stores Inc 5
→ Walgreen Company 4
→ Walgreens 2
→ Walgreens Company 1
→ Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 1

7-ELEVEN

A-S Medication Solutions

NDC Product
Human Otc Drug

Childrens Loratadine Oral
NDC 50090-7516

Generic Name
Loratadine
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

AMERISOURCEBERGEN DRUG CORPORATION

NDC Product
Human Otc Drug

Infant Gas Relief
NDC 46122-547

Generic Name
Simethicone
Dosage Form
Suspension/ Drops
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

ATLANTIC BIOLOGICALS CORP.

Acadia Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Daybue
NDC 63090-660

Generic Name
Trofinetide
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing

Actavis Pharma, Inc.

NDC Product
Human Prescription Drug

Levetiracetam
NDC 0472-0235

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Aldi Inc

Alvogen Inc.

Amarin Pharma Inc.

NDC Product
Human Prescription Drug

Vascepa
NDC 52937-001

Generic Name
Icosapent Ethyl
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Vascepa
NDC 52937-003

Generic Name
Icosapent Ethyl
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Vascepa
NDC 52937-101

Generic Name
Icosapent Ethyl
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing

American Health Packaging

NDC Product
Human Prescription Drug

Levetiracetam
NDC 60687-249

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Amerisource Bergen

Amneal Pharmaceuticals LLC

NDC Product
Human Prescription Drug

Levetiracetam
NDC 65162-685

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Aquestive Therapeutics

NDC Product
Human Prescription Drug

Sympazan
NDC 10094-205

Generic Name
Clobazam
Dosage Form
Film
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Sympazan
NDC 10094-210

Generic Name
Clobazam
Dosage Form
Film
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Sympazan
NDC 10094-220

Generic Name
Clobazam
Dosage Form
Film
Route
Oral
Marketing
NDA
Active Listing

Army & Air Force Exchange Service

Ascend Laboratories, LLC

NDC Product
Human Prescription Drug

Lanthanum Carbonate
NDC 67877-256

Generic Name
Lanthanum Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lanthanum Carbonate
NDC 67877-257

Generic Name
Lanthanum Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lanthanum Carbonate
NDC 67877-258

Generic Name
Lanthanum Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Clobazam
NDC 67877-658

Generic Name
Clobazam
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing

Atlantic Biologicals

NDC Product
Human Otc Drug

Childrens Loratadine Oral
NDC 17856-6767

Generic Name
Loratadine
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Atlantic Biologicals Corp.

NDC Product
Human Prescription Drug

Levetiracetam Levetiracetam
NDC 17856-0574

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Aurobindo Pharma Limited

NDC Product
Human Prescription Drug

Clobazam
NDC 59651-401

Generic Name
Clobazam
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 65862-250

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Aurohealth LLC

NDC Product
Human Otc Drug

Loratadine
NDC 58602-423

Generic Name
Loratadine Oral
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Aveva Drug Delivery Systems Inc.

NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 3215-6521

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 3215-6522

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 3215-6523

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 3215-6524

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing

Bayer HealthCare LLC.

NDC Product
Human Otc Drug

Claritin Allergy
NDC 11523-0101

Generic Name
Loratadine
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Children Claritin Allergy
NDC 11523-4360

Generic Name
Loratadine
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing

Best Choice

NDC Product
Human Otc Drug

Dm Max
NDC 63941-518

Generic Name
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage Form
Solution
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Best Choice (Valu Merchandisers Company)

NDC Product
Human Otc Drug

Nighttime Cold And Cough Childrens
NDC 63941-984

Generic Name
Diphenhydramine Hcl, Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Better Living Brands LLC

NDC Product
Human Otc Drug

Loratadine
NDC 21130-042

Generic Name
Loratadine Oral
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

BluePoint Laboratories

NDC Product
Human Otc Drug

Loratadine
NDC 68001-449

Generic Name
Loratadine Oral
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Bryant Ranch Prepack

NDC Product
Human Prescription Drug

Levocetirizine Dihydrochloride
NDC 63629-2533

Generic Name
Levocetirizine Dihydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Vascepa
NDC 63629-8247

Generic Name
Icosapent Ethyl
Dosage Form
Capsule
Route
Oral
Marketing
NDA
Active Listing

CMP Pharma, Inc.

NDC Product
Human Prescription Drug

Norliqva
NDC 46287-035

Generic Name
Amlodipine
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing

CVS Pharmacy, Inc.

CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

NDC Product
Human Otc Drug

Childrens Allergy Relief
NDC 51316-611

Generic Name
Loratadine
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Camber Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 31722-479

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film, Soluble
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 31722-480

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film, Soluble
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 31722-481

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film, Soluble
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 31722-482

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film, Soluble
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 31722-574

Generic Name
Levetiracetam Oral
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Clobazam
NDC 31722-641

Generic Name
Clobazam
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levocetirizine Dihydrochloride
NDC 31722-659

Generic Name
Levocetirizine Dihydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Cardinal Health 107, LLC

NDC Product
Human Prescription Drug

Levetiracetam
NDC 55154-4316

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 55154-5782

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Chain Drug Consortium, LLC

NDC Product
Human Otc Drug

Night Time Severe Cold And Cough Relief
NDC 68016-154

Generic Name
Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Chartwell RX, LLC

NDC Product
Human Prescription Drug

Clobazam
NDC 62135-527

Generic Name
Clobazam
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levocetirizine Dihydrochloride
NDC 62135-917

Generic Name
Levocetirizine Dihydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Chattem, Inc.

NDC Product
Human Prescription Drug

Xyzal
NDC 41167-5804

Generic Name
Levocetirizine Dihydrochloride
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing

DENTAL ALLIANCE HOLDINGS LLC

NDC Product
Human Prescription Drug

Pro Gel 5000 Mint
NDC 61578-215

Generic Name
Sodium Fluoride
Dosage Form
Gel, Dentifrice
Route
Dental
Marketing
UNAPPROVED DRUG OTHER
Active Listing
NDC Product
Human Prescription Drug

Pro Gel 5000 Citrus
NDC 61578-216

Generic Name
Sodium Fluoride
Dosage Form
Gel, Dentifrice
Route
Dental
Marketing
UNAPPROVED DRUG OTHER
Active Listing

DISCOUNT DRUG MART

NDC Product
Human Otc Drug

Discount Drug Mart
NDC 53943-509

Generic Name
Cough Drops Vitamin C Sugar-free
Dosage Form
Lozenge
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

DLC Laboratories, Inc.

NDC Product
Human Otc Drug

Quita Colicos Gas Relief Drops
NDC 24286-1533

Generic Name
Simethicone
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Dental Alliance Holdings LLC

NDC Product
Human Otc Drug

Gel 1100 Mint
NDC 61578-213

Generic Name
Sodium Fluoride
Dosage Form
Gel, Dentifrice
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Gel 1100 Citrus
NDC 61578-214

Generic Name
Sodium Fluoride
Dosage Form
Gel, Dentifrice
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Gel 1100 Grape
NDC 61578-217

Generic Name
Sodium Fluoride
Dosage Form
Gel, Dentifrice
Route
Dental
Marketing
OTC MONOGRAPH DRUG
Active Listing

Discount Drug Mart

NDC Product
Human Otc Drug

Childrens Cough Mucus Relief
NDC 53943-512

Generic Name
Dextromethorphann Hbr, Guaifenesin
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Maxium Strength Dm Max
NDC 53943-518

Generic Name
Dextromethorphan Hydrobromide, Guaifenesin
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Dolgencorp Inc

NDC Product
Human Otc Drug

Dg Health Migraine Relief
NDC 55910-448

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Dg Health Headache Relief
NDC 55910-639

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

NDC Product
Human Otc Drug

Triacting Daytime Cold Cough Childrens
NDC 55910-378

Generic Name
Dextromethorphan Hbr, Phenylephrine Hcl
Dosage Form
Syrup
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Headache Relief Extra Strength
NDC 55910-686

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Severe Cold And Cough Relief Daytime
NDC 55910-801

Generic Name
Acetaminohpen, Dextromethorphan Hbr, Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Dolgencorp, LLC

NDC Product
Human Otc Drug

Dg Health Childrens Allergy
NDC 55910-611

Generic Name
Loratadine
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Dr.Reddys Laboratories Inc

NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 43598-579

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film, Soluble
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 43598-580

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film, Soluble
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 43598-581

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film, Soluble
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 43598-582

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film, Soluble
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing

E.R. Squibb & Sons, L.L.C.

NDC Product
Human Prescription Drug

Baraclude
NDC 0003-1614

Generic Name
Entecavir
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing

EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)

NDC Product
Human Otc Drug

Headache Relief Extra Strength
NDC 49035-786

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Family Dollar (FAMILY WELLNESS)

NDC Product
Human Otc Drug

Daytime Cold And Flu
NDC 55319-960

Generic Name
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Family Dollar Services, Inc.

Fertin Pharma A/S

NDC Product
Human Otc Drug

Nicotine Polacrilex Gum
NDC 63443-5057

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Buccal
Marketing
ANDA
Active Listing

Geri-Care Pharmaceuticals, Corp

NDC Product
Human Otc Drug

Infants Gas Relief
NDC 57896-798

Generic Name
Simethicone
Dosage Form
Suspension
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Guardian Drug Company

NDC Product
Human Prescription Drug

Levetiracetam
NDC 53041-660

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

H E B

NDC Product
Human Otc Drug

Maximum Strength Dm Max
NDC 37808-518

Generic Name
Dextromethorphan Hydrobromide, Guaifenesin
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Headache Relief Extra Strength
NDC 37808-586

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Daytime Severe Cold And Cough
NDC 37808-718

Generic Name
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

HY-VEE, INC

NDC Product
Human Otc Drug

Hyvee Throat Drops Lemon Mint
NDC 42507-907

Generic Name
Menthol
Dosage Form
Lozenge
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Haleon US Holdings LLC

NDC Product
Human Otc Drug

Theraflu Severe Cold Relief Nighttime
NDC 0067-0105

Generic Name
Acetaminophen, Diphenhydramine Hcl
Dosage Form
Syrup
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Theraflu Severe Cold Relief
NDC 0067-0107

Generic Name
Acetaminophen, Dextromethorphan Hbr, Diphenphydramine Hcl, G...
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Excedrin Extra Strength Geltabs
NDC 0067-2021

Generic Name
Acetaminophen, Asprin, Caffeine
Dosage Form
Tablet, Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Excedrin Migraine Geltabs
NDC 0067-2035

Generic Name
Acetaminophen, Asprin, Caffeine
Dosage Form
Tablet, Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Theraflu Expressmax Severe Cold And Flu Syrup
NDC 0067-8132

Generic Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephr...
Dosage Form
Syrup
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

INDIVIOR INC.

NDC Product
Human Prescription Drug

Suboxone
NDC 12496-1202

Generic Name
Buprenorphine Hydrochloride, Naloxone Hydrochloride
Dosage Form
Film, Soluble
Route
Buccal; Sublingual
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Suboxone
NDC 12496-1204

Generic Name
Buprenorphine Hydrochloride, Naloxone Hydrochloride
Dosage Form
Film, Soluble
Route
Buccal; Sublingual
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Suboxone
NDC 12496-1208

Generic Name
Buprenorphine Hydrochloride, Naloxone Hydrochloride
Dosage Form
Film, Soluble
Route
Buccal; Sublingual
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Suboxone
NDC 12496-1212

Generic Name
Buprenorphine Hydrochloride, Naloxone Hydrochloride
Dosage Form
Film, Soluble
Route
Buccal; Sublingual
Marketing
NDA
Active Listing

INGENUS PHARMACEUTICALS, LLC

NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 50742-364

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 50742-365

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing

KROGER COMPANY

NDC Product
Human Otc Drug

Loratadine
NDC 30142-062

Generic Name
Loratadine Oral
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

KVK-Tech, Inc.

NDC Product
Human Prescription Drug

Methylphenidate
NDC 10702-163

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Methylphenidate
NDC 10702-164

Generic Name
Methylphenidate Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Oxycodone Hydrochloride
NDC 10702-171

Generic Name
Oxycodone Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Oxycodone Hydrochloride
NDC 10702-183

Generic Name
Oxycodone Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Kroger Company

NDC Product
Human Otc Drug

Lansoprazole
NDC 30142-192

Generic Name
Lansoprazole
Dosage Form
Tablet, Orally Disintegrating, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Childrens Allergy Relief
NDC 30142-723

Generic Name
Loratadine
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

L. Perrigo Company

NDC Product
Human Otc Drug

Good Sense Lansoprazole
NDC 0113-0116

Generic Name
Lansoprazole
Dosage Form
Tablet, Orally Disintegrating, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Migraine Formula
NDC 0113-1619

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Good Sense Headache Relief
NDC 0113-1855

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Good Sense Nicotine
NDC 0113-4111

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing

Lundbeck Pharmaceuticals LLC

NDC Product
Human Prescription Drug

Onfi
NDC 67386-313

Generic Name
Clobazam
Dosage Form
Suspension
Route
Oral
Marketing
NDA
Active Listing

MAJOR PHARMACEUTICALS

NDC Product
Human Prescription Drug

Levetiracetam
NDC 0904-7420

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Major Pharmaceuticals

NDC Product
Human Otc Drug

Childrens Loratadine Oral
NDC 0904-6767

Generic Name
Loratadine
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 0904-7265

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Meijer, Inc.

NDC Product
Human Otc Drug

Childrens Allergy Relief
NDC 41250-716

Generic Name
Loratadine
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Method Pharmaceuticals

Mondelez Global LLC

Mylan Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 0378-8765

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 0378-8766

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 0378-8767

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 0378-8768

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing

Nelson Bach USA Limited

NDC Product
Human Otc Drug

Bach Pastilles Orange And Elderflower
NDC 57687-245

Generic Name
Helianthemum Nummularium Whole, Prunus Cerasifera Whole, Orn...
Dosage Form
Lozenge
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Rescue Pastilles Mixed Berry Flavour
NDC 57687-307

Generic Name
Rescue Pastilles Mixed Berry Flavour
Dosage Form
Lozenge
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

Nelson Bach USA Ltd

NDC Product
Human Otc Drug

Rescue Pastille Black Currant
NDC 57687-247

Generic Name
Helianthemum Nummularium Flower, Clematis Vitalba Top, Impat...
Dosage Form
Lozenge
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Rescue Pastilles Cranberry
NDC 57687-300

Generic Name
Helianthemum Nummularium Flower, Clematis Vitalba Flower, Im...
Dosage Form
Lozenge
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Rescue Pastille Lemon
NDC 57687-303

Generic Name
Helianthemum Nummularium Flower, Clematis Vitalba Top, Impat...
Dosage Form
Lozenge
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Rescue Sleep Pastilles Blackcurrant
NDC 57687-320

Generic Name
Rescue Sleep Pastilles Blackcurrant
Dosage Form
Lozenge
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Rescue Pastilles Watermelon Flavour
NDC 57687-321

Generic Name
Rescue Pastilles
Dosage Form
Lozenge
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Rescue Pastilles Kids Strawberry Flavor
NDC 57687-322

Generic Name
Cherry Plum, Clematis, Impatiens, Rock Rose, Star Of Bethleh...
Dosage Form
Lozenge
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

NorthStar Rx LLC

NDC Product
Human Prescription Drug

Levetiracetam
NDC 16714-358

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

NorthStar RxLLC

NDC Product
Human Prescription Drug

Clobazam
NDC 16714-087

Generic Name
Clobazam
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing

P & L Development, LLC

NDC Product
Human Otc Drug

Severe Cold And Cough Relief Daytime
NDC 49580-0501

Generic Name
Acetaminohpen, Dextromethorphan Hbr, Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Nighttime Severe Cold And Cough
NDC 49580-0502

Generic Name
Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

PAI Holdings, LLC dba PAI Pharma

NDC Product
Human Prescription Drug

Levetiracetam
NDC 0121-0799

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 0121-1598

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 0121-2397

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Levetiracetam
NDC 0121-4799

Generic Name
Levetiracetam
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Padagis Israel Pharmaceuticals Ltd

NDC Product
Human Prescription Drug

Levocetirizine Dihydrochloride
NDC 45802-680

Generic Name
Levocetirizine Dihydrochloride
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Pharmadel LLC

NDC Product
Human Otc Drug

Sanatos Mucus Relief Cold Toddlers
NDC 55758-307

Generic Name
Dextromethorphan Hbr, Guaifenesin
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Sanatos Boost
NDC 55758-323

Generic Name
Dextromethorphan Hbr
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Qilu Pharmaceutical Co., Ltd.

NDC Product
Human Prescription Drug

Icosapent Ethyl
NDC 67184-0582

Generic Name
Icosapent Ethyl
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing

RB Health (US) LLC

Redpharm Drug

NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 67296-2063

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Buprenorphine And Naloxone
NDC 67296-2228

Generic Name
Buprenorphine And Naloxone
Dosage Form
Film
Route
Buccal; Sublingual
Marketing
ANDA
Active Listing

Rite Aid

NDC Product
Human Otc Drug

Ultra Strength Antacid Peppermint
NDC 11822-3480

Generic Name
Calcium Carbonate
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Rite Aid Corporation

NDC Product
Human Otc Drug

Childrens Allergy Relief
NDC 11822-0620

Generic Name
Loratadine
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Safeway, Inc.

NDC Product
Human Otc Drug

Triacting Daytime Cold Cough Childrens
NDC 21130-378

Generic Name
Dextromethorphan Hbr, Phenylephrine Hcl
Dosage Form
Syrup
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Childrens Cold And Cough Nighttime
NDC 21130-379

Generic Name
Diphenhydramine Hcl, Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Headache Relief Extra Strength
NDC 21130-586

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Sun Pharmaceutical Industries, Inc.

TARGET Corporation

NDC Product
Human Otc Drug

Headache Relief Extra Strength
NDC 11673-686

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

TOP CARE (Topco Associates LLC)

NDC Product
Human Otc Drug

Flu Relief Therapy Nighttime
NDC 36800-317

Generic Name
Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Taro Pharmaceuticals U.S.A., Inc.

NDC Product
Human Prescription Drug

Clobazam
NDC 51672-4227

Generic Name
Clobazam
Dosage Form
Suspension
Route
Oral
Marketing
ANDA
Active Listing

The Kroger Co.

NDC Product
Human Otc Drug

Headache Relief Extra Strength
NDC 30142-586

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Topco Associates LLC

NDC Product
Human Otc Drug

Topcare Lansoprazole
NDC 36800-295

Generic Name
Lansoprazole
Dosage Form
Tablet, Orally Disintegrating, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Topcare Childrens Allergy
NDC 36800-608

Generic Name
Loratadine
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Topcare Migraine Relief
NDC 36800-934

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

U.S. Pharmaceuticals

NDC Product
Human Prescription Drug

Duavee
NDC 63539-122

Generic Name
Conjugated Estrogens/bazedoxifene
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing

United Natural Foods, Inc. dba UNFI

Validus Pharmaceuticals LLC

NDC Product
Human Prescription Drug

Atoncy
NDC 30698-456

Generic Name
Atomoxetine Hydrochloride
Dosage Form
Solution
Route
Oral
Marketing
NDA
Active Listing

WALGREEN COMPANY

NDC Product
Human Otc Drug

Loratadine
NDC 0363-0771

Generic Name
Loratadine
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Wal-Mart Stores Inc

NDC Product
Human Otc Drug

Equate Nicotine
NDC 49035-365

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Equate Lansoprazole
NDC 49035-373

Generic Name
Lansoprazole
Dosage Form
Tablet, Orally Disintegrating, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Equate Nicotine
NDC 49035-442

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Childrens Allergy
NDC 49035-538

Generic Name
Loratadine
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Equate Childrens Allergy
NDC 49035-611

Generic Name
Loratadine
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Walgreen Company

NDC Product
Human Otc Drug

Migraine Relief
NDC 0363-1235

Generic Name
Acetaminophen, Aspirin, Caffeine
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Lansoprazole
NDC 0363-1419

Generic Name
Lansoprazole
Dosage Form
Tablet, Orally Disintegrating, Delayed Release
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Otc Drug

Nicotine
NDC 0363-7050

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Nicotine
NDC 0363-7103

Generic Name
Nicotine Polacrilex
Dosage Form
Gum, Chewing
Route
Oral
Marketing
ANDA
Active Listing

Walgreens

NDC Product
Human Otc Drug

Cold And Congestion Childrens Nighttime
NDC 0363-0058

Generic Name
Diphenhydramine Hci, Phenylephrine Hcl
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Walgreens Company

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

NDC Product
Human Prescription Drug

Duavee
NDC 0008-1123

Generic Name
Conjugated Estrogens/bazedoxifene
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing

External Clinical & Regulatory Resources

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