PEPPERMINT
UNII V95R5KMY2B

Substance Identification & Data

This profile provides standardized clinical and technical data for Peppermint, uniquely identified by the FDA Unique Ingredient Identifier (UNII) V95R5KMY2B.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number N/A and the RxNorm Concept ID (RxCUI) 1010971. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
V95R5KMY2B
CAS Registry Number
N/A
RxNorm Concept ID
1010971

Detailed Substance Profile

Preferred Name
PEPPERMINT
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
V95R5KMY2B
The specific atomic composition represented as a molecular structure string.
NCI Thesaurus
C66347
National Cancer Institute reference terminology for clinical and research data.
Substance Type
structurallyDiverse
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
ITIS TSN
32275
Taxonomic Serial Number for species identified in the Integrated Taxonomic Information System.
NCBI Taxonomy
34256
Unique numeric identifier used to specify biological species in the NCBI database.
USDA PLANTS ID
MEPI
Botanical identifier maintained by the U.S. Department of Agriculture.
GRIN Nomen ID
24078
Identifier from the Germplasm Resources Information Network botanical database.
MPNS Record
WCS-125188
Record ID from the Kew Royal Botanic Gardens Medicinal Plants Name Service.

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Peppermint. 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

MENTHA PIPERITA (PEPPERMINT) FLOWER/LEAF/STEM EXTRACT

Common Names & Synonyms

AE-PEPPERMINT
ALLERGENIC EXTRACT- PEPPERMINT MENTHA PIPERITA
BRANDY MINT FLOWERING TOP
FOOD - PLANT SOURCE, PEPPERMINT MENTHA PIPERITA
LAMB MINT FLOWERING TOP
MENTHA CRISPA FLOWERING TOP
MENTHA DUMETORUM FLOWERING TOP
MENTHA PIPERITA FLOWERING TOP
MENTHA X PIPERITA FLOWERING TOP
PEPPERMINT
PEPPERMINT ALLERGENIC EXTRACT
PEPPERMINT EXTRACT
PEPPERMINT FLOWERING TOP
PEPPERMINT POWDER
PEPPERMINT POWDER [VANDF]
PEPPERMINT PREPARATION
PEPPERMINT, FRESH
PEPPERMINT,FRESH

Technical Codes

B1449 [LANGUAL]

NDC Products Containing PEPPERMINT

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 (500), only Active Listings are currently displayed.
→ ATLANTIC BIOLOGICALS CORP. 2
→ Advance Pharmaceutical Inc. 2
→ Ahold U.S.A., Inc, 1
→ Akorn 2
→ Alembic Pharmaceuticals Inc. 1
→ Alembic Pharmaceuticals Limited 1
→ Amerisource Bergen 1
→ Amneal Pharmaceuticals LLC 1
→ Amneal Pharmaceuticals of New York LLC 3
→ Apex Energetics Inc. 1
→ Army & Air Force Exchange Service 2
→ Aurobindo Pharma Limited 5
→ Aurohealth LLC 4
→ AvKARE 2
→ Avaria Health & Beauty Corp 1
→ Avaria Health and Beauty Corp 1
→ Better Living Brands, LLC 1
→ Bryant Ranch Prepack 5
→ CDMA- QC 1
→ CVS Pharmacy 2
→ Camber Pharmaceuticals, Inc. 5
→ Cardinal Health 107, LLC 1
→ Chartwell RX, LLC 5
→ DISCOUNT DRUG MART 1
→ DLC LABORATORIES, INC. 1
→ ENDO USA, Inc. 2
→ Eagle Indo Pharma, PT 1
→ Eminence Organic Skin Care Ltd. 4
→ Endo USA, Inc. 5
→ Epic Laboratories, LLC 1
→ Fertin Pharma A/S 1
→ Geri-Care Pharmaceuticals, Corp 1
→ Golden State Medical Supply, Inc. 2
→ HF Acquisition Co LLC, DBA HealthFirst 2
→ HY-VEE, INC 2
→ Healing Natural Oils LLC 2
→ Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 2
→ Hikma Pharmaceuticals USA Inc. 1
→ Hisun Pharmaceuticals USA, Inc. 2
→ Humco Holding Group, Inc. 2
→ Jubilant Cadista Pharmacuticals Inc. 13
→ LABORATORIO MAGNACHEM INTERNATIONAL SRL 1
→ Lannett Company, Inc. 1
→ MENPER DISTRIBUTORS INC. 1
→ Macleods Pharmaceuticals Limited 5
→ Major Pharmaceuticals 1
→ Medline Industries, LP 3
→ Menper Distributors, Inc. 2
→ Method Pharmaceuticals, LLC 1
→ Mylan Institutional Inc. 1
→ Mylan Pharmaceuticals Inc. 2
→ Par Health USA, LLC 4
→ Patrin Pharma, Inc. 1
→ Pfizer Laboratories Div Pfizer Inc 3
→ PharmPak, Inc. 1
→ Proficient Rx LP 2
→ PuraCap Pharmaceutical LLC 1
→ QPharma, Inc. 2
→ QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) 1
→ Richmond Pharmaceuticals, Inc. 1
→ Ricola Ag 1
→ Ricola USA Inc. 1
→ Rising Pharma Holdings, Inc. 7
→ Rowpar Pharmaceuticals, Inc. 3
→ Rugby Laboratories 1
→ Safecor Health, LLC 1
→ Sage Products LLC 2
→ Seroyal USA 1
→ Sinsin Pharmaceutical Co., Ltd. 3
→ Strides Pharma Science Limited 2
→ Sun Pharmaceutical Industries, Inc. 1
→ Target Corporation Inc. 1
→ Teva Pharmaceuticals USA, Inc. 3
→ The Procter & Gamble Manufacturing Company 1
→ Topco Associates LLC 1
→ Torrent Pharmaceuticals Limited 1
→ Unifirst First Aid Corporation 1
→ Vitality Works 1
→ WALGREEN CO 1
→ WALGREEN CO. 2
→ WHOLE FOODS MARKET, INC. 1
→ Wal-Mart Stores, Inc. 2
→ Wasatch Product Development 1

ATLANTIC BIOLOGICALS CORP.

NDC Product
Human Otc Drug

Simethicone 125 Mg
NDC 17856-0137

Generic Name
Simethicone
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Prescription Drug

Citalopram Hydrobromide
NDC 17856-0564

Generic Name
Citalopram Hydrobromide
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Advance Pharmaceutical Inc.

NDC Product
Human Otc Drug

Gas Relief
NDC 17714-019

Generic Name
Simethicone
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH FINAL
Active Listing
NDC Product
Human Otc Drug

Simethicone
NDC 17714-040

Generic Name
Simethicone
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH FINAL
Active Listing

Ahold U.S.A., Inc,

NDC Product
Human Otc Drug

Loratadine Odt
NDC 60000-950

Generic Name
Loratadine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

Akorn

NDC Product
Human Prescription Drug

Famotidine
NDC 50383-913

Generic Name
Famotidine
Dosage Form
Powder, For Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Trihexyphenidyl Hydrochloride
NDC 61748-054

Generic Name
Trihexyphenidyl Hydrochloride
Dosage Form
Syrup
Route
Oral
Marketing
ANDA
Active Listing

Alembic Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Vardenafil
NDC 62332-235

Generic Name
Vardenafil
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

Alembic Pharmaceuticals Limited

NDC Product
Human Prescription Drug

Vardenafil
NDC 46708-235

Generic Name
Vardenafil
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

Amerisource Bergen

NDC Product
Human Otc Drug

Loratadine Odt
NDC 46122-539

Generic Name
Loratadine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

Amneal Pharmaceuticals LLC

NDC Product
Human Prescription Drug

Nizatidine
NDC 60846-301

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

Amneal Pharmaceuticals of New York LLC

NDC Product
Human Prescription Drug

Spironolactone
NDC 53746-511

Generic Name
Spironolactone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone
NDC 53746-514

Generic Name
Spironolactone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone
NDC 53746-515

Generic Name
Spironolactone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Apex Energetics Inc.

NDC Product
Human Otc Drug

F15 Mnd-mmry
NDC 63479-0615

Generic Name
Agnus Castus, Allegheny Monkeyflower, Anacardium Orientale, ...
Dosage Form
Solution/ Drops
Route
Sublingual
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

Army & Air Force Exchange Service

Aurobindo Pharma Limited

NDC Product
Human Prescription Drug

Clozapine
NDC 59651-260

Generic Name
Clozapine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Clozapine
NDC 59651-261

Generic Name
Clozapine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Clozapine
NDC 59651-262

Generic Name
Clozapine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Clozapine
NDC 59651-263

Generic Name
Clozapine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Clozapine
NDC 59651-264

Generic Name
Clozapine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

Aurohealth LLC

NDC Product
Human Otc Drug

Loratadine Odt
NDC 58602-744

Generic Name
Loratadine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Loratadine Odt
NDC 58602-821

Generic Name
Loratadine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Loratadine Odt
NDC 58602-830

Generic Name
Loratadine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Loratadine Odt
NDC 58602-881

Generic Name
Loratadine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

AvKARE

NDC Product
Human Prescription Drug

Zolmitriptan Od
NDC 42291-998

Generic Name
Zolmitriptan
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Zolmitriptan Od
NDC 42291-999

Generic Name
Zolmitriptan
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

Avaria Health & Beauty Corp

NDC Product
Human Otc Drug

Kalaya Breathe Easy Vaporizing Rub
NDC 43493-0004

Generic Name
Vaporizing Rub
Dosage Form
Ointment
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Avaria Health and Beauty Corp

NDC Product
Human Otc Drug

Kalaya Breath Refresh
NDC 43493-0005

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

Better Living Brands, LLC

NDC Product
Human Otc Drug

Loratadine Odt
NDC 21130-221

Generic Name
Loratadine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

Bryant Ranch Prepack

NDC Product
Human Prescription Drug

Spironolactone And Hydrochlorothiazide
NDC 63629-1068

Generic Name
Spironolactone And Hydrochlorothiazide
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone And Hydrochlorothiazide
NDC 63629-1069

Generic Name
Spironolactone And Hydrochlorothiazide
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone And Hydrochlorothiazide
NDC 63629-1071

Generic Name
Spironolactone And Hydrochlorothiazide
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone
NDC 63629-2437

Generic Name
Spironolactone
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone
NDC 63629-2438

Generic Name
Spironolactone
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

CDMA- QC

NDC Product
Human Otc Drug

Stomach Relief
NDC 63868-622

Generic Name
Bismuth Subsalicylate
Dosage Form
Tablet
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

CVS Pharmacy

NDC Product
Human Otc Drug

Natural Herb Cough Drops
NDC 51316-850

Generic Name
Menthol Herb
Dosage Form
Pastille
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Lemon Mint Herb Throat Drops
NDC 51316-852

Generic Name
Sugar Free Lemon Mint Herb
Dosage Form
Pastille
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Camber Pharmaceuticals, Inc.

NDC Product
Human Prescription Drug

Diclofenac Potassium
NDC 31722-046

Generic Name
Diclofenac Potassium
Dosage Form
Powder, For Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Famotidine
NDC 31722-063

Generic Name
Famotidine
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nitrofurantoin
NDC 31722-491

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

Citalopram Hydrobromide
NDC 31722-564

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

Escitalopram Oxalate
NDC 31722-569

Generic Name
Escitalopram Oxalate
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing

Cardinal Health 107, LLC

NDC Product
Human Prescription Drug

Nifedipine
NDC 55154-0196

Generic Name
Nifedipine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing

Chartwell RX, LLC

NDC Product
Human Prescription Drug

Nifedipine
NDC 62135-739

Generic Name
Nifedipine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nifedipine
NDC 62135-740

Generic Name
Nifedipine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Diazepam
NDC 62135-767

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

Diazepam
NDC 62135-768

Generic Name
Diazepam Oral Solution (concentrate)
Dosage Form
Solution
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Cyproheptadine
NDC 62135-949

Generic Name
Cyproheptadine Hydrochloride
Dosage Form
Syrup
Route
Oral
Marketing
ANDA
Active Listing

DISCOUNT DRUG MART

NDC Product
Human Otc Drug

Loratadine Odt
NDC 53943-035

Generic Name
Loratadine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

DLC LABORATORIES, INC.

NDC Product
Human Otc Drug

De La Cruz Desempacho
NDC 24286-1523

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

ENDO USA, Inc.

NDC Product
Human Prescription Drug

Zolpidem Tartrate Sublingual
NDC 49884-898

Generic Name
Zolpidem Tartrate Sublingual
Dosage Form
Tablet
Route
Sublingual
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Zolpidem Tartrate Sublingual
NDC 49884-899

Generic Name
Zolpidem Tartrate Sublingual
Dosage Form
Tablet
Route
Sublingual
Marketing
ANDA
Active Listing

Eagle Indo Pharma, PT

NDC Product
Human Otc Drug

Eagle Balm
NDC 60954-010

Generic Name
Camphor Menthol
Dosage Form
Ointment
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Eminence Organic Skin Care Ltd.

NDC Product
Human Otc Drug

Acne Advanced Treatment System
NDC 15751-3000

Generic Name
Salicylic Acid
Dosage Form
Kit
Route
N/A
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Acne Advanced Cleansing
NDC 15751-3010

Generic Name
Salicylic Acid
Dosage Form
Liquid
Route
Topical
Marketing
OTC MONOGRAPH FINAL
Active Listing
NDC Product
Human Otc Drug

Acne Advanced Clarifying Masque
NDC 15751-3020

Generic Name
Salicylic Acid
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Acne Advanced Clarifying Hydrator
NDC 15751-3030

Generic Name
Salicylic Acid
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Endo USA, Inc.

NDC Product
Human Prescription Drug

Lamotrigine
NDC 49884-484

Generic Name
Lamotrigine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lamotrigine
NDC 49884-485

Generic Name
Lamotrigine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lamotrigine
NDC 49884-486

Generic Name
Lamotrigine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Lamotrigine
NDC 49884-487

Generic Name
Lamotrigine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Diclofenac Potassium
NDC 49884-905

Generic Name
Diclofenac Potassium
Dosage Form
Powder, For Solution
Route
Oral
Marketing
ANDA
Active Listing

Epic Laboratories, LLC

NDC Product
Human Otc Drug

Therapain Plus
NDC 58418-827

Generic Name
Menthol Roll-on
Dosage Form
Liquid
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

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

Extra Strength Gas Relief
NDC 57896-292

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

Golden State Medical Supply, Inc.

NDC Product
Human Prescription Drug

Rizatriptan Benzoate
NDC 51407-679

Generic Name
Rizatriptan Benzoate
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Rizatriptan Benzoate
NDC 51407-680

Generic Name
Rizatriptan Benzoate
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

HF Acquisition Co LLC, DBA HealthFirst

NDC Product
Human Prescription Drug

Nitroglycerin Lingual
NDC 51662-1393

Generic Name
Nitroglycerin Lingual
Dosage Form
Spray
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nitroglycerin Lingual
NDC 51662-1423

Generic Name
Nitroglycerin Lingual
Dosage Form
Spray
Route
Oral
Marketing
ANDA
Active Listing

HY-VEE, INC

NDC Product
Human Otc Drug

Hyvee Cough Drops Original Herb
NDC 42507-906

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

Healing Natural Oils LLC

NDC Product
Human Otc Drug

H-headaches Formula
NDC 61077-038

Generic Name
Apium Graveolens, Nux Vomica
Dosage Form
Oil
Route
Topical
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

H-joint And Muscle Formula
NDC 61077-137

Generic Name
Arnica Montana, Bellis Perennis, Chamomilla
Dosage Form
Oil
Route
Topical
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Nifedipine
NDC 23155-194

Generic Name
Nifedipine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Nifedipine
NDC 23155-195

Generic Name
Nifedipine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing

Hikma Pharmaceuticals USA Inc.

NDC Product
Human Prescription Drug

Citalopram
NDC 0054-0062

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

Hisun Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Donepezil Hydrochloride
NDC 42658-119

Generic Name
Donepezil Hydrochloride
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Donepezil Hydrochloride
NDC 42658-120

Generic Name
Donepezil Hydrochloride
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

Humco Holding Group, Inc.

NDC Product
Human Otc Drug

Povidone Iodine
NDC 0395-9128

Generic Name
Povidone Iodine Gargle 0.5%
Dosage Form
Liquid
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Povidone Iodine
NDC 0395-9136

Generic Name
Povidone Iodine Oral Rinse 0.5%
Dosage Form
Liquid
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Jubilant Cadista Pharmacuticals Inc.

NDC Product
Human Prescription Drug

Risperidone
NDC 59746-010

Generic Name
Risperidone
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Risperidone
NDC 59746-020

Generic Name
Risperidone
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Risperidone
NDC 59746-030

Generic Name
Risperidone
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Risperidone
NDC 59746-040

Generic Name
Risperidone
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Risperidone
NDC 59746-050

Generic Name
Risperidone
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone
NDC 59746-216

Generic Name
Spironolactone
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone
NDC 59746-216

Generic Name
Spironolactone
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone
NDC 59746-217

Generic Name
Spironolactone
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone
NDC 59746-217

Generic Name
Spironolactone
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone
NDC 59746-218

Generic Name
Spironolactone
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone
NDC 59746-218

Generic Name
Spironolactone
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Zolmitriptan Od
NDC 59746-461

Generic Name
Zolmitriptan
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Zolmitriptan Od
NDC 59746-462

Generic Name
Zolmitriptan
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

LABORATORIO MAGNACHEM INTERNATIONAL SRL

NDC Product
Human Otc Drug

Broncochem Maximum Cough Kids
NDC 65131-180

Generic Name
Dextromethorphan Hbr-guaifenesin
Dosage Form
Syrup
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Lannett Company, Inc.

NDC Product
Human Prescription Drug

Famotidine
NDC 0527-5190

Generic Name
Famotidine
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing

MENPER DISTRIBUTORS INC.

NDC Product
Human Otc Drug

Bisolvine Aloe-miel
NDC 53145-402

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

Macleods Pharmaceuticals Limited

NDC Product
Human Prescription Drug

Escitalopram
NDC 33342-053

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

Memantine Hydrochloride
NDC 33342-066

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

Rizatriptan Benzoate
NDC 33342-093

Generic Name
Rizatriptan Benzoate
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Rizatriptan Benzoate
NDC 33342-094

Generic Name
Rizatriptan Benzoate
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Vardenafil
NDC 33342-203

Generic Name
Vardenafil
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Major Pharmaceuticals

NDC Product
Human Prescription Drug

Nifedipine
NDC 0904-7229

Generic Name
Nifedipine
Dosage Form
Capsule
Route
Oral
Marketing
ANDA
Active Listing

Medline Industries, LP

NDC Product
Human Otc Drug

Activice
NDC 53329-984

Generic Name
Menthol
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Activice
NDC 53329-991

Generic Name
Menthol
Dosage Form
Spray
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Activice
NDC 53329-992

Generic Name
Menthol
Dosage Form
Liquid
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Menper Distributors, Inc.

NDC Product
Human Otc Drug

Berro Y Cebolla Dm
NDC 53145-080

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

Anti-empacho
NDC 53145-300

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

Method Pharmaceuticals, LLC

Mylan Institutional Inc.

NDC Product
Human Prescription Drug

Clozapine
NDC 51079-288

Generic Name
Clozapine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

Mylan Pharmaceuticals Inc.

NDC Product
Human Prescription Drug

Clozapine
NDC 0378-3813

Generic Name
Clozapine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Clozapine
NDC 0378-3815

Generic Name
Clozapine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

Par Health USA, LLC

NDC Product
Human Prescription Drug

Alprazolam
NDC 49884-110

Generic Name
Alprazolam
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Alprazolam
NDC 49884-111

Generic Name
Alprazolam
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Alprazolam
NDC 49884-213

Generic Name
Alprazolam
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Alprazolam
NDC 49884-214

Generic Name
Alprazolam
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

Patrin Pharma, Inc.

NDC Product
Human Prescription Drug

Cyproheptadine Hydrochloride
NDC 39328-544

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

Pfizer Laboratories Div Pfizer Inc

NDC Product
Human Prescription Drug

Aldactone
NDC 0025-1001

Generic Name
Spironolactone
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Aldactone
NDC 0025-1031

Generic Name
Spironolactone
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing
NDC Product
Human Prescription Drug

Aldactone
NDC 0025-1041

Generic Name
Spironolactone
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
NDA
Active Listing

PharmPak, Inc.

NDC Product
Human Prescription Drug

Spironolactone
NDC 54348-340

Generic Name
Spironolactone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Proficient Rx LP

NDC Product
Human Prescription Drug

Spironolactone
NDC 63187-841

Generic Name
Spironolactone
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone
NDC 63187-861

Generic Name
Spironolactone
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing

PuraCap Pharmaceutical LLC

NDC Product
Human Otc Drug

Extra Strength Antacid
NDC 51013-323

Generic Name
Calcium Carbonate
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH FINAL
Active Listing

QPharma, Inc.

NDC Product
Human Prescription Drug

Spironolactone
NDC 42708-101

Generic Name
Spironolactone
Dosage Form
Tablet, Film Coated
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone
NDC 42708-126

Generic Name
Spironolactone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)

NDC Product
Human Otc Drug

Qc Gas Relief Mint Flavor
NDC 63868-108

Generic Name
Simethicone
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Richmond Pharmaceuticals, Inc.

NDC Product
Human Otc Drug

Simethicone
NDC 54738-518

Generic Name
Simethicone
Dosage Form
Tablet, Chewable
Route
Oral
Marketing
OTC MONOGRAPH FINAL
Active Listing

Ricola Ag

Ricola USA Inc.

Rising Pharma Holdings, Inc.

NDC Product
Human Prescription Drug

Escitalopram Oxalate
NDC 16571-769

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

Rizatriptan Benzoate
NDC 57237-085

Generic Name
Rizatriptan Benzoate
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Rizatriptan Benzoate
NDC 57237-086

Generic Name
Rizatriptan Benzoate
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Phenytoin
NDC 64980-573

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

Spironolactone
NDC 64980-706

Generic Name
Spironolactone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone
NDC 64980-707

Generic Name
Spironolactone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Spironolactone
NDC 64980-708

Generic Name
Spironolactone
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Rowpar Pharmaceuticals, Inc.

NDC Product
Human Otc Drug

Closys
NDC 58578-0749

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

Closys Fluoride Rinse
NDC 58578-1234

Generic Name
Sodium Fluoride
Dosage Form
Rinse
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Rugby Laboratories

NDC Product
Human Otc Drug

Loratadine Odt
NDC 0536-1367

Generic Name
Loratadine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

Safecor Health, LLC

NDC Product
Human Prescription Drug

Clozapine
NDC 48433-022

Generic Name
Clozapine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

Sage Products LLC

NDC Product
Human Otc Drug

Antiseptic Oral Rinse
NDC 53462-175

Generic Name
Cetylpyridinium Chloride
Dosage Form
Mouthwash
Route
Buccal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Antiplaque Solution
NDC 53462-275

Generic Name
Cetylpyridinium Chloride
Dosage Form
Mouthwash
Route
Buccal
Marketing
OTC MONOGRAPH DRUG
Active Listing

Seroyal USA

NDC Product
Human Otc Drug

Unda 19
NDC 62106-1118

Generic Name
Aluminium Metallicum, Drosera, Illicium Verum, Mentha Piperi...
Dosage Form
Liquid
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

Sinsin Pharmaceutical Co., Ltd.

NDC Product
Human Otc Drug

Sinsinpap Cool
NDC 55264-012

Generic Name
Levomenthol, Thymol, Camphor, Mentha, Eucalyptus
Dosage Form
Patch
Route
Cutaneous; Topical; Transdermal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Arex Sinsin Pas
NDC 55264-020

Generic Name
Camphor, Mentha Oil, Menthol, Methyl Salicylate, Zinc Oxide
Dosage Form
Patch
Route
Cutaneous; Topical; Transdermal
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Arex Sinsin Pas
NDC 55264-021

Generic Name
Camphor, Mentha Oil, Menthol, Methyl Salicylate, Zinc Oxide
Dosage Form
Patch
Route
Cutaneous; Topical; Transdermal
Marketing
OTC MONOGRAPH DRUG
Active Listing

Strides Pharma Science Limited

NDC Product
Human Prescription Drug

Omeprazole/sodium Bicarbonate
NDC 64380-182

Generic Name
Omeprazole
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Omeprazole/sodium Bicarbonate
NDC 64380-183

Generic Name
Omeprazole
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing

Sun Pharmaceutical Industries, Inc.

NDC Product
Human Prescription Drug

Spironolactone And Hydrochlorothiazide
NDC 53489-144

Generic Name
Spironolactone And Hydrochlorothiazide
Dosage Form
Tablet
Route
Oral
Marketing
ANDA
Active Listing

Target Corporation Inc.

NDC Product
Human Otc Drug

Natural Herbal Cough Drops
NDC 11673-144

Generic Name
Cough Drops
Dosage Form
Pastille
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Teva Pharmaceuticals USA, Inc.

NDC Product
Human Prescription Drug

Clozapine
NDC 0093-5416

Generic Name
Clozapine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Clozapine
NDC 0093-5417

Generic Name
Clozapine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Prescription Drug

Clozapine
NDC 0093-5419

Generic Name
Clozapine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

The Procter & Gamble Manufacturing Company

NDC Product
Human Otc Drug

Head And Shoulders Itchy Scalp 2in1
NDC 37000-081

Generic Name
Pyrithione Zinc
Dosage Form
Lotion/shampoo
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Topco Associates LLC

NDC Product
Human Otc Drug

Menthol
NDC 36800-252

Generic Name
Maximum Strength Medicated Foot Powder Talc Free
Dosage Form
Powder
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Torrent Pharmaceuticals Limited

NDC Product
Human Prescription Drug

Diclofenac Potassium
NDC 13668-672

Generic Name
Diclofenac Potassium
Dosage Form
Powder, For Solution
Route
Oral
Marketing
ANDA
Active Listing

Unifirst First Aid Corporation

NDC Product
Human Otc Drug

Pain Relief
NDC 47682-321

Generic Name
Analgesic Menthol
Dosage Form
Spray
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Vitality Works

NDC Product
Human Otc Drug

Slenderiix
NDC 64616-077

Generic Name
Weight Management Formula
Dosage Form
Liquid
Route
Oral
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

WALGREEN CO

NDC Product
Human Otc Drug

Ultra Strength Antacid
NDC 0363-2730

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

WALGREEN CO.

NDC Product
Human Otc Drug

Childrens Loratadine Odt
NDC 0363-4020

Generic Name
Loratadine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Loratadine Odt
NDC 0363-9937

Generic Name
Loratadine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

WHOLE FOODS MARKET, INC.

NDC Product
Human Otc Drug

Herbal Flavor Menthol Cough Drops
NDC 42681-0039

Generic Name
Herbal Flavor Menthol Cough Drops
Dosage Form
Pastille
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing

Wal-Mart Stores, Inc.

NDC Product
Human Otc Drug

Loratadine Odt
NDC 49035-806

Generic Name
Loratadine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing
NDC Product
Human Otc Drug

Loratadine Odt
NDC 49035-806

Generic Name
Loratadine
Dosage Form
Tablet, Orally Disintegrating
Route
Oral
Marketing
ANDA
Active Listing

Wasatch Product Development

NDC Product
Human Otc Drug

Te-fu Recovery Massage
NDC 44717-539

Generic Name
Menthol, Methyl Salicylate
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

External Clinical & Regulatory Resources

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