Home NDC 0316-0227 PanOxyl
Product NDC 0316-0227
11-digit product format 003160227
Labeler code 0316
Product ID 0316-0227_48343359-a966-5327-e063-6294a90a54e5
Type HUMAN OTC DRUG
Nonproprietary name benzoyl peroxide
Dosage form CREAM
Route TOPICAL
Labeler Crown Laboratories
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-03-25
Substance BENZOYL PEROXIDE
Active strength 58.7 mg/g
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 58.7 mg/g
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0316-0227 PANOXYL (BENZOYL PEROXIDE) CREAM [CROWN LABORATORIES] 23 Current NDC, Legacy NDC, 4 package rows 20240717_7b301b94-3cc8-b05b-e053-2991aa0aa561.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 55 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Replenix Acne Gly-Sal 2-2 Foaming Cleanser SALICYLIC ACID Topiderm, Inc. 811dbf95-2b39-45c5-99a2-33c3c9d19570 2019-12-19 Warnings Exact identifier application number: M006 REPLENIX ACNE SOLUTIONS WASH BENZOYL PEROXIDE Topiderm, Inc. 8dc2d27d-3cc4-4874-b4c2-32607849b205 2019-12-17 Warnings Exact identifier application number: M006 REPLENIX ACNE Solution BENZOYL PEROXIDE WASH BENZOYL PEROXIDE Topiderm, Inc. 235e9dd5-13f2-4078-9807-1d87fd9e6cba 2019-12-17 Warnings Exact identifier application number: M006 Replenix Acne BENZOYL PEROXIDE Topiderm, Inc 03d4c298-8f44-41f7-b086-96ae836152bb 2019-10-31 Warnings Exact identifier application number: M006 Replenix Acne BENZOYL PEROXIDE Topiderm, Inc. c12f9005-a549-4447-9beb-df7126f77df1 2019-10-31 Warnings Exact identifier application number: M006 Gly-Sal 10-2 Pads SALICYLIC ACID Topiderm, Inc. b39e845d-4c40-4f9e-9cb5-a8386f326652 2019-10-23 Warnings Exact identifier application number: M006 Gly-Sal 5-2 Pads SALICYLIC ACID Topiderm, Inc. e73bd26c-cdc2-47ab-94e8-3bc49a9b19e8 2019-10-22 Warnings Exact identifier application number: M006 SKIN MEDICA Purifying Foaming Wash SALICYLIC ACID Allergan, Inc. 064d9e2b-077f-4229-b653-666fc5479ae2 2013-03-01 Warnings Exact identifier application number: M006
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0316-0227-06 00316022706 1 TUBE in 1 CARTON (0316-0227-06) / 170 g in 1 TUBE 1 tube 2018-12-01 0000-00-00 No No Current 0316-0227-10 00316022710 1 in 1 CARTON Historical