Home NDC 0316-0264-01 PanOxyl
Product NDC 0316-0264
Requested package NDC 0316-0264-01
11-digit product format 003160264
Labeler code 0316
Product ID 0316-0264_48342795-9bf2-4541-e063-6394a90a10be
Type HUMAN OTC DRUG
Nonproprietary name Benzoyl Peroxide
Dosage form SOAP
Route TOPICAL
Labeler Crown Laboratories
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-01
Substance BENZOYL PEROXIDE
Active strength 12.6 g/113g
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 PanOxyl
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOYL PEROXIDE 12.6 g/113g
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 0316-0264-01 PanOxyl 43 g in 1 CARTON SOAP 43 6 0316-0264-04 PanOxyl 113 g in 1 CARTON SOAP 113 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0316-0264 PANOXYL (BENZOYL PEROXIDE) SOAP [CROWN LABORATORIES] 4 Current NDC, 2 package rows 20240713_ff09cbab-304b-4da9-e053-6394a90ae600.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 7 of 55 · 1,088 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0316-0264-01 00316026401 43 g in 1 CARTON (0316-0264-01) 43 g 2024-02-23 No No Current