Home NDC 78863-1180 Benzoazeline Forte
Product NDC 78863-1180
11-digit product format 788631180
Labeler code 78863
Product ID 78863-1180_0a9a9e4f-2fed-4c1a-b9dd-b04e975c987b
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 2022-01-09
Substance BENZOYL PEROXIDE
Active strength .2 g/50g
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 Forte
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOYL PEROXIDE .2 g/50g
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 78863-1180-2 Benzoazeline Forte 50 g in 1 TUBE, WITH APPLICATOR CREAM 50 3 78863-1180-2 Benzoazeline Forte 1 in 1 CARTON CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78863-1180 BENZOAZELINE FORTE (BENZOYL PEROXIDE) CREAM [NOON AESTHETICS M.R. LTD] 2 Current NDC, Legacy NDC, 2 package rows 20240127_eb8c6984-2531-44c0-9a5d-5d64070f04ae.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 22 of 54 · 1,079 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 78863-1180-2 78863118002 1 TUBE, WITH APPLICATOR in 1 CARTON (78863-1180-2) / 50 g in 1 TUBE, WITH APPLICATOR 2022-01-09 0000-00-00 No No Current