ORANGE OIL, COLD PRESSED
UNII AKN3KSD11B

Substance Identification & Data

This profile provides standardized clinical and technical data for Orange Oil, Cold Pressed, uniquely identified by the FDA Unique Ingredient Identifier (UNII) AKN3KSD11B.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 8008-57-9 and the RxNorm Concept ID (RxCUI) 1309230. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code
AKN3KSD11B
CAS Registry Number
8008-57-9
RxNorm Concept ID
1309230

Detailed Substance Profile

Preferred Name
ORANGE OIL, COLD PRESSED
Official standardized name for this substance within the FDA UNII nomenclature system.
Molecular Formula
AKN3KSD11B
The specific atomic composition represented as a molecular structure string.
NCI Thesaurus
C107337
National Cancer Institute reference terminology for clinical and research data.
Substance Type
structurallyDiverse
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
ITIS TSN
825213
Taxonomic Serial Number for species identified in the Integrated Taxonomic Information System.
NCBI Taxonomy
2711
Unique numeric identifier used to specify biological species in the NCBI database.
USDA PLANTS ID
CISI
Botanical identifier maintained by the U.S. Department of Agriculture.
GRIN Nomen ID
10689
Identifier from the Germplasm Resources Information Network botanical database.
MPNS Record
WCSCMP-3287406
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 Orange Oil, Cold Pressed. 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

CITRUS AURANTIUM DULCIS (ORANGE) OIL
CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL

Common Names & Synonyms

CITRUS AURANTIUM DULCIS (SWEET ORANGE) OIL
CITRUS SINENSIS (SWEET ORANGE) PEEL OIL
CITRUS SINENSIS FRUIT RIND OIL
CITRUS SINENSIS OIL
OIL OF ORANGE
OIL OF ORANGE [HSDB]
OIL OF ORANGE [MI]
OILS, ORANGE
ORANGE OIL
ORANGE OIL [II]
ORANGE OIL [JAN]
ORANGE OIL [VANDF]
ORANGE OIL EXTRACT
ORANGE OIL, COLD PRESSED
ORANGE OIL, COLD-PRESSED
ORANGE OIL, COLDPRESSED [FCC]
ORANGE OIL, SWEET
ORANGE PEEL SWEET OIL [FHFI]
ORANGE VOLATILE OIL
SWEET ORANGE OIL [MART.]

Technical Codes

FEMA NO. 2825

NDC Products Containing ORANGE OIL, COLD PRESSED

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. Display is limited to the first 200 products.
→ 3LAB, INC 1
→ 3LAB, Inc 3
→ Adaptive Health, LLC 1
→ Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 5
→ Allure LAbs 1
→ Allure Labs 4
→ Allure Labs Inc 1
→ Allure Labs, Inc 1
→ Ambi Enterprise LLC 1
→ Andalou naturals 5
→ Autumn Harp 2
→ BLUEZONWIDE CO.,LTD 2
→ Bali Body Pty Ltd 2
→ Baxter Laboratories Pty. Ltd. 1
→ Bu Brands, LLC 1
→ CMS LAB Inc. 1
→ COSMAX USA, CORPORATION 4
→ Cannanumb LLC 1
→ Clinical Resolution Laboratory, Inc. 1
→ Conopco Inc. d/b/a/ Unilever 2
→ Corganics, LP 1
→ CosMedical Technologies, LLC 1
→ Cosmetic Enterprise Ltd 1
→ DUKE CANNON SUPPLY CO. 1
→ Dermalogica 1
→ Dermalogica, Inc 1
→ Dermalogica, Inc. 2
→ Dermalogica, LLC. 4
→ Devatis Inc. 1
→ Devatis, Inc. 1
→ Dr. Loretta, LLC 1
→ EO Products, LLC 3
→ Ebanel Laboratories, Inc 1
→ FRUIT OF THE EARTH, INC. 1
→ Fruit of the Earth, Inc. 2
→ GOJO Industries, Inc. 2
→ GSCM Ventures Inc. DBA Revitol 1
→ H-E-B 1
→ H.E.B 1
→ Have & Be Co., Ltd. 5
→ Hello Bello 3
→ Human Science, LLC 1
→ HydroPeptide LLC 1
→ IT COSMETICS, LLC 7
→ Isagenix International, LLC 1
→ June Jacobs Labs LLC 2
→ June Jacobs Labs, LLC 3
→ KOS� America, Inc. 1
→ KW ABSC, INC. 14
→ L'BRI HEALTH & BEAUTY 1
→ LABORATORIO MAGNACHEM INTERNATIONAL SRL 2
→ LG H&H CO., LTD. 2
→ LG HOUSEHOLD & HEALTH CARE LTD. 1
→ LG Household and Healthcare, Inc. 2
→ Laboratoires Dermo-Cosmetik Inc. 1
→ Lotus Brands, Inc. 2
→ METROPOLITANGRAPHIC ARTS, Inc. 1
→ Medline Industries, LP 4
→ Merrick Medicine Company, Inc 1
→ Nelson Bach USA Limited 1
→ Neora, LLC 2
→ ORIGINS NATURAL RESOURCES INC. 7
→ PERENNEBELL Co., Ltd 2
→ PERENNEBELL Co., Ltd. 1
→ Peer Pharm Ltd. 3
→ Private Label Skin Care 1
→ Product Management, LLC 1
→ Pur-lisse Beauty, LLC 11
→ RB Health (US) LLC 2
→ Rite Aid 1
→ STL International INC 2
→ Spry Life LLC 2
→ Supergoop, LLC 2
→ Superior Chemical Corporation 3
→ Swiss-American CDMO, LLC 3
→ Synchronicity Spa, Inc. DBA Suntegrity 2
→ THE KROGER COMPANY 1
→ The Caldrea Company 1
→ The Hain Celestial Group, Inc. 2
→ The Procter & Gamble Manufacturing Company 3
→ Tom's of Maine, Inc. 1
→ Tropical Seas, Inc. 1
→ Twin Med LLC 2
→ W.S. Badger Company, Inc. 2
→ YENSA Beauty, LLC 16
→ doTERRA International, LLC 2
→ e.l.f. Cosmetics, Inc. 1

3LAB, INC

NDC Product
Human Otc Drug

3lab Ww Day Spf40 Broad Spectrum
NDC 76159-205

Generic Name
Homosalate, Octisalate, Avobenzone, Octocrylene
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

3LAB, Inc

Adaptive Health, LLC

NDC Product
Human Otc Drug

Instaflex Pain Relief Cream
NDC 72779-100

Generic Name
Menthol
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH NOT FINAL
Active Listing

Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions

NDC Product
Human Otc Drug

Myco Clinic Pain Relief
NDC 24909-010

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

Myco Clinic Pain Relief
NDC 24909-011

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

Myco Clinic Pain Relief
NDC 24909-012

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

Myco Clinic Pain Relief
NDC 24909-013

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

Allure LAbs

NDC Product
Human Otc Drug

Prevention Clear Solar Gel Spf30
NDC 62742-4226

Generic Name
Avobenzon, Octisalate And Octocrylene
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Allure Labs

NDC Product
Human Otc Drug

Prevention Sun Serum Spf30
NDC 62742-4225

Generic Name
Zinc Oxide
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Allure Labs Inc

Allure Labs, Inc

Ambi Enterprise LLC

Andalou naturals

NDC Product
Human Otc Drug

1000 Roses Daily Shade Facial Spf 18
NDC 55560-0103

Generic Name
Octisalate, Octocrylene, And Avobenzone
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Ultra Sheer Daily Defense Facial Spf 18
NDC 55560-3331

Generic Name
Homosalate, Octisalate, And Avobenzone
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Autumn Harp

BLUEZONWIDE CO.,LTD

Bali Body Pty Ltd

NDC Product
Human Otc Drug

Bali Body Tinted Super Serum Natural Spf 30
NDC 70630-0031

Generic Name
Octisalate, Octocrylene, Titanium Dioxide, Zinc Oxide
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Bali Body Tinted Super Serum Tan Spf 30
NDC 70630-0032

Generic Name
Octisalate, Octocrylene, Titanium Dioxide, Zinc Oxide
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Baxter Laboratories Pty. Ltd.

NDC Product
Human Otc Drug

Sun Glazed Spf 30 Sunscreen Glow Oil
NDC 70157-034

Generic Name
Avobenzone, Homosalate, Octocrylene
Dosage Form
Oil
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Bu Brands, LLC

CMS LAB Inc.

COSMAX USA, CORPORATION

NDC Product
Human Otc Drug

Musely Daycream Spf40
NDC 68577-198

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

Herbal Uv Defense Spf40
NDC 68577-199

Generic Name
Homosalate, Octisalate, Avobenzone, Octocrylene
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Cannanumb LLC

NDC Product
Human Otc Drug

Canna Numb Roll On
NDC 72614-265

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

Clinical Resolution Laboratory, Inc.

NDC Product
Human Otc Drug

Fungus Master
NDC 63742-098

Generic Name
Miconazole Nitrate
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Conopco Inc. d/b/a/ Unilever

NDC Product
Human Otc Drug

Love Beauty And Planet
NDC 64942-1841

Generic Name
Beloved Cherry Blossom And Tea Rose Hand Sanitizer
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Love Beauty And Planet
NDC 64942-1842

Generic Name
Beloved Patchouli And Orange Flower Hand Sanitizer
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Corganics, LP

NDC Product
Human Otc Drug

Relief Pain Relieving Cream
NDC 58559-001

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

CosMedical Technologies, LLC

NDC Product
Human Otc Drug

Ultra Replenishing Sunscreen Spf 40
NDC 70060-1901

Generic Name
Homosalate, Octisalate, Octocrylene, Zinc Oxyide Cream
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Cosmetic Enterprise Ltd

DUKE CANNON SUPPLY CO.

NDC Product
Human Otc Drug

Cannon Balm 140
NDC 71782-141

Generic Name
Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone
Dosage Form
Stick
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Dermalogica

NDC Product
Human Otc Drug

Breakout Clearing Foaming Wash
NDC 68479-101

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

Dermalogica, Inc

NDC Product
Human Otc Drug

Age Bright Clearing Serum
NDC 68479-184

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

Dermalogica, Inc.

NDC Product
Human Otc Drug

Overnight Clearing
NDC 68479-706

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

Clearing Defense Spf 30
NDC 68479-807

Generic Name
Avobenzone, Homosalate, Octisalate, And Octocrylene
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Dermalogica, LLC.

NDC Product
Human Otc Drug

Deep Acne
NDC 68479-240

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

Breakout Clearing Booster
NDC 68479-773

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

Clarifying Bacne
NDC 68479-782

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

Clearing Defense Spf30
NDC 68479-872

Generic Name
Octocrylene, Homosalate, Octisalate, And Avobenzone
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Devatis Inc.

NDC Product
Human Prescription Drug

Amoxicillin And Clavulanate Potassium
NDC 73043-008

Generic Name
Amoxicillin And Clavulanate Potassium
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing

Devatis, Inc.

NDC Product
Human Prescription Drug

Amoxicillin And Clavulanate Potassium
NDC 73043-010

Generic Name
Amoxicillin And Clavulanate Potassium
Dosage Form
Powder, For Suspension
Route
Oral
Marketing
ANDA
Active Listing

Dr. Loretta, LLC

NDC Product
Human Otc Drug

Urban Antioxidant Sunscreen Spf 40
NDC 71501-1902

Generic Name
Homosalate, Octisalate, Octocrylene, Zinc Oxyide Cream
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

EO Products, LLC

Ebanel Laboratories, Inc

NDC Product
Human Otc Drug

Fungus Master Antifungal Treatment
NDC 72654-001

Generic Name
Miconazole Nitrate
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

FRUIT OF THE EARTH, INC.

Fruit of the Earth, Inc.

GOJO Industries, Inc.

GSCM Ventures Inc. DBA Revitol

NDC Product
Human Otc Drug

Acne Forte Acne Treatment Cream
NDC 52063-709

Generic Name
Benzoyl Peroxide
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

H-E-B

H.E.B

Have & Be Co., Ltd.

NDC Product
Human Otc Drug

Dr.jart Premium Beauty Balm Fair-light
NDC 49404-148

Generic Name
Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Dr.jart Premium Beauty Balm Medium-tan
NDC 49404-150

Generic Name
Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Dr.jart Premium Beauty Balm Deep Tan-deep
NDC 49404-151

Generic Name
Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Hello Bello

NDC Product
Human Otc Drug

Baby Mineral Sunscreen Spf55
NDC 73418-100

Generic Name
Zinc Oxide
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Mineral Sunscreen Spf 50
NDC 73418-102

Generic Name
Zinc Oxide
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Human Science, LLC

NDC Product
Human Otc Drug

Human Science Muscle Pain Relief
NDC 71356-818

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

HydroPeptide LLC

NDC Product
Human Otc Drug

Solar Defense Body
NDC 60934-004

Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage Form
Aerosol, Spray
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

IT COSMETICS, LLC

Isagenix International, LLC

June Jacobs Labs LLC

NDC Product
Human Otc Drug

Rapid Repair Healing Cream
NDC 65278-110

Generic Name
Allantoin, Dimethicone
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

June Jacobs Labs, LLC

NDC Product
Human Otc Drug

Advanced Sun Resistance Spf 30
NDC 65278-319

Generic Name
Homosalate, Octinoxate, Oxybenzone, Octisalate, Avobenzone
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

KOS� America, Inc.

NDC Product
Human Otc Drug

Sekkisei Herbal Uv Defense Gel
NDC 66820-0400

Generic Name
Avobenzone, Homosalate, Octisalate, And Octocrylene
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

KW ABSC, INC.

NDC Product
Human Otc Drug

Cle Ccc Warm Light
NDC 69231-023

Generic Name
Titanium Dioxide, Octinoxate, Octisalate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH NOT FINAL
Active Listing
NDC Product
Human Otc Drug

Cle Ccc Warm Medium Light
NDC 69231-024

Generic Name
Titanium Dioxide, Octinoxate, Octisalate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH NOT FINAL
Active Listing
NDC Product
Human Otc Drug

Cle Ccc Warm Medium
NDC 69231-025

Generic Name
Titanium Dioxide, Octinoxate, Octisalate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH NOT FINAL
Active Listing
NDC Product
Human Otc Drug

Cle Ccc Warm Medium Deep
NDC 69231-026

Generic Name
Titanium Dioxide, Octinoxate, Octisalate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH NOT FINAL
Active Listing
NDC Product
Human Otc Drug

Cle Ccc Golden Medium Deep
NDC 69231-027

Generic Name
Titanium Dioxide, Octinoxate, Octisalate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH NOT FINAL
Active Listing
NDC Product
Human Otc Drug

Cle Ccc Neutral Light
NDC 69231-028

Generic Name
Titanium Dioxide, Octinoxate, Octisalate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cle Ccc Neutral Medium Light
NDC 69231-029

Generic Name
Titanium Dioxide, Octinoxate, Octisalate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cle Ccc Neutral Medium
NDC 69231-030

Generic Name
Titanium Dioxide, Octinoxate, Octisalate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cle Ccc Cool Medium Deep
NDC 69231-031

Generic Name
Titanium Dioxide, Octinoxate, Octisalate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cle Ccc Warm Deep
NDC 69231-032

Generic Name
Titanium Dioxide, Octinoxate, Octisalate, Avobenzone
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cle Ccc Neutral Fair
NDC 69231-033

Generic Name
Titanium Dioxide, Octinoxate, Octisalate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cle Ccc Golden Medium
NDC 69231-034

Generic Name
Titanium Dioxide, Octinoxate, Octisalate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cle Ccc Olive Medium Deep
NDC 69231-035

Generic Name
Titanium Dioxide, Octinoxate, Octisalate
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Cle Ccc Neutral Deep
NDC 69231-036

Generic Name
Titanium Dioxide, Octinoxate, Octisalate, Avobenzone
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

L'BRI HEALTH & BEAUTY

NDC Product
Human Otc Drug

Lbri Pure N Natural Spf 30
NDC 71238-326

Generic Name
Zinc Oxide
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

LABORATORIO MAGNACHEM INTERNATIONAL SRL

NDC Product
Human Otc Drug

Broncochem Maximum Cough Night
NDC 65131-035

Generic Name
Dextromethorphan Hbr-pyrilamine Maleate
Dosage Form
Syrup
Route
Oral
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Broncochem Maximum Cough Night
NDC 65131-110

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

LG H&H CO., LTD.

NDC Product
Human Otc Drug

Belif Aqua Bomb - Glow Sunstick Spf50
NDC 53208-730

Generic Name
Homosalate, Octocrylene, Ethylhexyl Salicylate, Butyl Methox...
Dosage Form
Stick
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Belif Aqua Bomb - Glow Sunstick Spf50
NDC 53208-731

Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage Form
Stick
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

LG HOUSEHOLD & HEALTH CARE LTD.

LG Household and Healthcare, Inc.

Laboratoires Dermo-Cosmetik Inc.

NDC Product
Human Otc Drug

Gm Collin Puracne
NDC 64127-195

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

Lotus Brands, Inc.

METROPOLITANGRAPHIC ARTS, Inc.

Medline Industries, LP

NDC Product
Human Otc Drug

Medline
NDC 53329-147

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

Remedy Nutrashield
NDC 53329-157

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

Remedy Antifungal With Olivamine
NDC 53329-162

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

Remedy Calazime Skin Protectant
NDC 53329-165

Generic Name
Calamine, Menthol, White Petrolatum, Zinc Oxide
Dosage Form
Paste
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Merrick Medicine Company, Inc

NDC Product
Human Otc Drug

Percy Medicine
NDC 0322-2222

Generic Name
Bismuth Subsalicylate
Dosage Form
Liquid
Route
Oral
Marketing
OTC MONOGRAPH DRUG
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

Neora, LLC

NDC Product
Human Otc Drug

Neora Age Iq Invisi-bloc Sunscreen
NDC 72935-002

Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Neora Age Iq Invisi-bloc Sunscreen
NDC 72935-003

Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

ORIGINS NATURAL RESOURCES INC.

NDC Product
Human Otc Drug

Ginzing Spf 30 Daily Moisturizer
NDC 59427-116

Generic Name
Avobenzone,homosalate,octisalate,octocrylene
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

PERENNEBELL Co., Ltd

PERENNEBELL Co., Ltd.

NDC Product
Human Otc Drug

Some By Mi V10 Hyal Lip Sun Protector
NDC 74472-703

Generic Name
Avobenzone, Homosalate, Octisalate
Dosage Form
Lipstick
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Peer Pharm Ltd.

Private Label Skin Care

NDC Product
Human Otc Drug

Clarifying Cleanser
NDC 72957-011

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

Product Management, LLC

NDC Product
Human Otc Drug

No Bs Moisturizer Spf20
NDC 71852-334

Generic Name
Octinoxate, Octisalate, Avobenzone
Dosage Form
Lotion
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Pur-lisse Beauty, LLC

RB Health (US) LLC

Rite Aid

STL International INC

NDC Product
Human Otc Drug

Teeter Renew Muscles Pain Relieving
NDC 70329-717

Generic Name
Methyl Salicylate, Menthol
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing
NDC Product
Human Otc Drug

Teeter Renew Muscles Pain Relieving
NDC 70329-730

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

Spry Life LLC

NDC Product
Human Otc Drug

Sweet Honey Lip Balm
NDC 70994-401

Generic Name
Zinc Oxide, Calendula Officials Flowers
Dosage Form
Salve
Route
Topical
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing
NDC Product
Human Otc Drug

Citrus Zest Lip Balm
NDC 70994-402

Generic Name
Calendula Officials Flowers
Dosage Form
Salve
Route
Topical
Marketing
UNAPPROVED HOMEOPATHIC
Active Listing

Supergoop, LLC

Superior Chemical Corporation

NDC Product
Human Otc Drug

North Woods Derma Gel Clear
NDC 53125-801

Generic Name
Alcohol
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Swiss-American CDMO, LLC

NDC Product
Human Otc Drug

Image Prevention Refiner Primer Spf50
NDC 60232-1830

Generic Name
Zinc Oxide, Titanium Dioxide Sunscreen
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Synchronicity Spa, Inc. DBA Suntegrity

NDC Product
Human Otc Drug

Natural Mineral Body Sunscreen
NDC 69949-100

Generic Name
Zinc Oxide
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

THE KROGER COMPANY

NDC Product
Human Otc Drug

Kroger Invisible Sunscreen Spf 40
NDC 30142-239

Generic Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage Form
Gel
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

The Caldrea Company

The Hain Celestial Group, Inc.

NDC Product
Human Otc Drug

Avalon Organics Antidandruff
NDC 61995-1606

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

The Procter & Gamble Manufacturing Company

NDC Product
Human Otc Drug

Old Spice Pure Sport High Endurance
NDC 69423-611

Generic Name
Aluminum Zirconium Pentachlorohydrex Gly
Dosage Form
Stick
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Tom's of Maine, Inc.

Tropical Seas, Inc.

NDC Product
Human Otc Drug

Expedition Backcountry Spf 30
NDC 52854-326

Generic Name
Octocrylene, Octisalate, And Avobenzone
Dosage Form
Spray
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

Twin Med LLC

NDC Product
Human Otc Drug

Procure Dimethicone 5%
NDC 55681-024

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

Procure Skin Repair Cream
NDC 55681-033

Generic Name
Dimethicone 1.5%
Dosage Form
Cream
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

W.S. Badger Company, Inc.

YENSA Beauty, LLC

doTERRA International, LLC

NDC Product
Human Otc Drug

On Guard Sanitizing Gel
NDC 71630-098

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

On Guard Sanitizing Wipes
NDC 71630-383

Generic Name
Alcohol
Dosage Form
Cloth
Route
Topical
Marketing
OTC MONOGRAPH DRUG
Active Listing

e.l.f. Cosmetics, Inc.

External Clinical & Regulatory Resources

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