Home NDC 57337-168-01 Spot Acne Treatment Oil Free 0.75oz
Product NDC 57337-168
Requested package NDC 57337-168-01
11-digit product format 573370168
Labeler code 57337
Product ID 57337-168_212f77ca-82d4-6a78-e063-6394a90aed32
Type HUMAN OTC DRUG
Nonproprietary name Salicylic Acid
Dosage form CREAM
Route TOPICAL
Labeler Rejoice International Corp.
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-02
Substance SALICYLIC ACID
Active strength 2 g/100g
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 Spot Acne Treatment Oil Free 0.75oz
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID 2 g/100g
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 317152 Internal RxNorm 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 57337-168-01 Spot Acne Treatment Oil Free 0.75oz 21 g in 1 TUBE CREAM 21 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57337-168 SPOT ACNE TREATMENT OIL FREE 0.75OZ (SALICYLIC ACID) CREAM [REJOICE INTERNATIONAL CORP.] 1 Current NDC, 1 package rows 20240904_212f77ca-82d3-6a78-e063-6394a90aed32.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 42 of 54 · 1,079 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 57337-168-01 57337016801 21 g in 1 TUBE (57337-168-01) 21 g 2024-09-02 No No Current