Home NDC 78863-1300 BenzoAzeline 5
Product NDC 78863-1300
11-digit product format 788631300
Labeler code 78863
Product ID 78863-1300_3f3bab85-a2c2-4b2b-97f0-be5007302b9e
Type HUMAN OTC DRUG
Nonproprietary name BENZOYL PEROXIDE
Dosage form CREAM
Route TOPICAL
Labeler Noon Aesthetics M.R. Ltd
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-01
Substance BENZOYL PEROXIDE
Active strength 500 mg/mL
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 BenzoAzeline 5
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOYL PEROXIDE 500 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W9WZN9A0GM Internal UNII 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 78863-1300-1 BenzoAzeline 5 1 in 1 CARTON CREAM 1 2 78863-1300-1 BenzoAzeline 5 50 mL in 1 TUBE CREAM 50 2 78863-1300-2 BenzoAzeline 5 1 in 1 CARTON CREAM 1 2 78863-1300-2 BenzoAzeline 5 15 mL in 1 BOTTLE, PUMP CREAM 15 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78863-1300 BENZOAZELINE 5 (BENZOYL PEROXIDE) CREAM [NOON AESTHETICS M.R. LTD] 1 Current NDC, 4 package rows 20240301_0db88619-a1be-46d0-b1e7-26253a8c50e5.zip
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 25 of 54 · 1,079 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Curology Acne-Clearing Gel Serum SALICYLIC ACID Curology, Inc. 3e636042-56a9-142b-e063-6394a90a9859 2025-09-09 Warnings Exact identifier application number: M006 Salicylic Acid 2% Solution SALICYLIC ACID Deciem 39fa19ee-9cc8-8fbc-e063-6394a90a96df 2025-09-09 Warnings Exact identifier application number: M006 Ology Acne Spot SALICYLIC ACID Walgreens Co. 59a97686-04c0-4d53-9efd-19a1c3ece2d8 2025-09-05 Warnings Exact identifier application number: M006 RoyceDerm Rosacea Treatment Cream. SULPHUR 1X HPUS(10%) RoyceDerm LLC 3df717fc-cf2f-8a9a-e063-6394a90ae4e2 2025-09-04 Warnings Exact identifier application number: M006 PHOFAY Salicylic Acid Acne Treatment Essence SALICYLIC ACID Hangzhou Jingshen Trading Co., Ltd. 1a03c857-1040-44ea-817d-7b472160ba6b 2025-09-04 Warnings Exact identifier application number: M006 Biore SALICYLIC ACID Kao USA Inc. 2e1e1aa2-5d41-baa4-e063-6394a90ac3f2 2025-08-31 Warnings Exact identifier application number: M006 Biore Pore Unclogging Scrub SALICYLIC ACID Kao USA Inc. 5667307e-0bab-41c3-a2d6-5ca860546833 2025-08-28 Warnings Exact identifier application number: M006 PHOFAY ACNE SPOTTREATMENT Cream SALICYLIC ACID Hangzhou Jingshen Trading Co., Ltd. 3d40c687-7110-46b1-e063-6394a90a8416 2025-08-26 Warnings Exact identifier application number: M006 PHOFAY ACNE SPOT TREATMENT Cream SALICYLIC ACID Longway Technology(Guangzhou) Co., Ltd. 3d0511f6-168b-5377-e063-6294a90a3ca9 2025-08-23 Warnings Exact identifier application number: M006 PAPATUI Acne Fighting Body SALICYLIC ACID PAPATUI, LLC 3cf9ec1a-4ac3-fceb-e063-6294a90a21a0 2025-08-22 Warnings Exact identifier application number: M006 PAPATUI Acne Fighting Facial Cleanser SALICYLIC ACID PAPATUI, LLC 3cfadbb6-fc5e-5696-e063-6394a90a21f4 2025-08-22 Warnings Exact identifier application number: M006 Neutrogena Oil-Free Acne Stress Control Power Clear Scrub SALICYLIC ACID Kenvue Brands LLC 3cc657cd-ad68-505a-e063-6394a90a41b2 2025-08-20 Warnings Exact identifier application number: M006 Neutrogena Body Clear Body Wash Pink Grapefruit SALICYLIC ACID Kenvue Brands LLC 3cc7eeb1-972c-25ec-e063-6294a90ae929 2025-08-20 Warnings Exact identifier application number: M006 Neutrogena Oil-Free Acne Wash Daily Scrub SALICYLIC ACID Kenvue Brands LLC 3ccd4c1b-3784-f767-e063-6294a90a3543 2025-08-20 Warnings Exact identifier application number: M006 Neutrogena Oil-Free Acne Wash Cream Cleanser SALICYLIC ACID Kenvue Brands LLC 3c9e91bf-664a-9341-e063-6294a90a7fca 2025-08-18 Warnings Exact identifier application number: M006 Neutrogena Oil-Free Acne Stress Control Power-Cream Wash SALICYLIC ACID Kenvue Brands LLC 3ca05f64-0b97-59b7-e063-6394a90ac5d8 2025-08-18 Warnings Exact identifier application number: M006 Ology Acne Clearing Body Mist SALICYLIC ACID Walgreens Co. 33621f58-9df4-a85e-e063-6294a90ae08e 2025-08-12 Warnings Exact identifier application number: M006 Micro Exfoliating Cleanser SALICYLIC ACID SOAP Dr. Loretta, LLC 7e6855db-a8d5-50ff-e053-2a91aa0a5e17 2025-08-06 Warnings Exact identifier application number: M006 Alumier MD Acne Balancing Serum SALICYLIC ACID Alumier Labs 87eb6adc-c38e-d7df-e053-2a95a90aa747 2025-08-06 Warnings Exact identifier application number: M006 my beauty spot BLEMISH DOTS - CHARCOAL (10 PATCHES) SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. cf36f10f-015d-491e-b8b9-99e130f67deb 2025-08-01 Warnings Exact identifier application number: M006
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 78863-1300-1 78863130001 1 TUBE in 1 CARTON (78863-1300-1) / 50 mL in 1 TUBE 1 tube 2024-03-01 No No Current 78863-1300-2 78863130002 1 BOTTLE, PUMP in 1 CARTON (78863-1300-2) / 15 mL in 1 BOTTLE, PUMP 2024-03-01 No No Current