Home NDC 85398-001 Folliculitis Cream
Product NDC 85398-001
11-digit product format 853980001
Labeler code 85398
Product ID 85398-001_58f42b88-6f07-46fd-e063-6294a90ad08f
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form CREAM
Route TOPICAL
Labeler Beautivity LLC
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-20
Substance MICONAZOLE NITRATE
Active strength 1.5 g/100g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Folliculitis Cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 1.5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VW4H1CYW1K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2712237 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85398-001-01 Folliculitis Cream 100 g in 1 BOTTLE CREAM 100 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 41 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Avene Cleanance Acne Medicated Clearing Treatment BENZOYL PEROXIDE Pierre Fabre USA Inc. facb99a0-f67e-80bf-e053-6294a90a2332 2024-11-06 Warnings Exact identifier application number: M006 Rugby Benzoyl Peroxide Acne Medication BENZOYL PEROXIDE A-S Medication Solutions a86ae901-53d0-4bfd-808e-59d9a7bc5ef6 2024-11-06 Warnings Exact identifier application number: M006 Meijer Acne Treatment Acne medication BENZOYL PEROXIDE Meijer Distribution, Inc f008ad20-03d0-45ae-8f75-249310eb9e70 2024-11-06 Warnings Exact identifier application number: M006 Meijer Invisible Acne Acne medication BENZOYL PEROXIDE Meijer Distribution, Inc 2a6ec3dd-572d-4314-afbf-23aff0d1e22a 2024-11-06 Warnings Exact identifier application number: M006 Aveeno CLEAR COMPLEXION foaming cleanser SALICYLIC ACID Kenvue Brands LLC 32425c63-7ed9-401b-a271-988b52b4f105 2024-11-05 Warnings Exact identifier application number: M006 Vivant Sulfur Clay Mask SULFUR Vivant Pharmaceuticals, LLC 10cd9db0-5388-b671-e063-6394a90af50d 2024-11-05 Warnings Exact identifier application number: M006 Vivant BP10% Gel Medication BENZOYL PEROXIDE Vivant Pharmaceuticals, LLC 10cc63b8-b4f9-6a78-e063-6294a90aade4 2024-11-05 Warnings Exact identifier application number: M006 Vivant BP3% Exfoliating Cleanser BENZOYL PEROXIDE Vivant Pharmaceuticals, LLC 10be3c7d-d09c-53a7-e063-6294a90a4f09 2024-11-05 Warnings Exact identifier application number: M006 Vivant BP3% Acne Wash BENZOYL PEROXIDE Vivant Pharmaceuticals, LLC 10bf5723-225f-67d7-e063-6394a90a72b1 2024-11-05 Warnings Exact identifier application number: M006 Meijer oil Free Acne Wash Facial Cleanser Pink Grapefruit Acne medication SALICYLIC ACID Meijer Distribution, Inc 3232b833-225f-429f-910c-d11874f3f1d5 2024-11-05 Warnings Exact identifier application number: M006 Neutrogena Oil Free Acne Stress Control Triple Action Toner SALICYLIC ACID Kenvue Brands LLC 817a9746-df57-4b11-b580-f57fe9940a68 2024-11-01 Warnings Exact identifier application number: M006 SkinMedica Acne Clarifying Treatment SALICYLIC ACID Allergan, Inc. 664d4733-e72d-410a-8ed0-a159d9dfa236 2024-11-01 Warnings Exact identifier application number: M006 Walgreens Acne Control Cleanser Acne Medication BENZOYL PEROXIDE Walgreen Company f33e4204-fed9-4f14-a00f-c81b1910254b 2024-10-31 Warnings Exact identifier application number: M006 Walgreens Acne Foaming Wash Acne Medication BENZOYL PEROXIDE Walgreen Company f34affe9-d470-48a5-b0d1-d62b9c44b3f2 2024-10-31 Warnings Exact identifier application number: M006 Clearing Skin Wash SALICYLIC ACID Dermalogica, LLC. 5cd31221-d6b4-47b9-99fd-fdfc2e1b6fdf 2024-10-30 Warnings Exact identifier application number: M006 Walgreens Acne Foaming Cleanser Acne Treatment BENZOYL PEROXIDE Walgreen Company 5b6fab38-4a9e-4c5c-967e-e3a0ff03b606 2024-10-30 Warnings Exact identifier application number: M006 ZO Skin Health Acne Control Benzoyl Peroxide BENZOYL PEROXIDE ZO Skin Health, Inc. 252b2352-a457-4009-a62b-0ec98f018b2e 2024-10-28 Warnings Exact identifier application number: M006 benzoyl peroxide BENZOYL PEROXIDE Padagis Israel Pharmaceuticals Ltd 9702add4-ea36-4c6b-9402-87b44f989a80 2024-10-23 Warnings Exact identifier application number: M006 benzoyl peroxide BENZOYL PEROXIDE Padagis Israel Pharmaceuticals Ltd 7441981a-654d-4f18-be21-66c863ee6d6f 2024-10-23 Warnings Exact identifier application number: M006 benzoyl peroxide BENZOYL PEROXIDE Padagis Israel Pharmaceuticals Ltd 0ba5e88c-a4d5-4550-93fa-d3d7fee45f9f 2024-10-23 Warnings Exact identifier application number: M006
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85398-001-01 85398000101 100 g in 1 BOTTLE (85398-001-01) 100 g 2025-04-20 No No Current