Home NDC 57337-034 Oil-Free Foaming Acne Wash Facial Cleanser
Product NDC 57337-034
11-digit product format 573370034
Labeler code 57337
Product ID 57337-034_126c1352-8e10-57d9-e063-6294a90abe83
Type HUMAN OTC DRUG
Nonproprietary name Salicylic Acid
Dosage form GEL
Route TOPICAL
Labeler Rejoice International
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-11-21
Substance SALICYLIC ACID
Active strength 4 mg/177mg
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 Oil-Free Foaming Acne Wash Facial Cleanser
Brand name suffix Tea Tree Oil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID 4 mg/177mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O414PZ4LPZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 562600 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57337-034-01 Oil-Free Foaming Acne Wash Facial CleanserTea Tree Oil 177 mg in 1 BOTTLE GEL 177 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-034 OIL-FREE FOAMING ACNE WASH FACIAL CLEANSER TEA TREE OIL (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL] 5 Current NDC, Legacy NDC, 1 package rows 20240229_7ae434d1-8b07-4121-9163-df07598d4156.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 40 of 55 · 1,088 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57337-034-01 57337003401 177 mg in 1 BOTTLE (57337-034-01) 177 mg 2013-11-21 0000-00-00 No No Current