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 29 of 54 · 1,079 matching rows.
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