Home NDC 54031-069 GOODBYE ACNE Complete treatment gel
Product NDC 54031-069
11-digit product format 540310069
Labeler code 54031
Product ID 54031-069_0a20cdf1-4008-331f-e063-6394a90a04dc
Type HUMAN OTC DRUG
Nonproprietary name Salicylic Acid
Dosage form GEL
Route TOPICAL
Labeler Peter Thomas Roth, LLC
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-06-15
Substance SALICYLIC ACID
Active strength .9638 g/48.19g
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 GOODBYE ACNE Complete treatment gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID .9638 g/48.19g
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 346298 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 54031-069-01 GOODBYE ACNE Complete treatment gel 48.19 g in 1 TUBE GEL 48.19 2 54031-069-02 GOODBYE ACNE Complete treatment gel 48.19 g in 1 CARTON GEL 48.19 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54031-069 GOODBYE ACNE COMPLETE TREATMENT GEL (SALICYLIC ACID) GEL [PETER THOMAS ROTH, LLC] 2 Current NDC, 2 package rows 20231115_09b88031-f5fe-8ae1-e063-6394a90a8a6a.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 14 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 Sample Exclude flag Status 54031-069-01 54031006901 48.19 g in 1 TUBE (54031-069-01) 48.19 g 2021-06-15 No No Current 54031-069-02 54031006902 48.19 g in 1 CARTON (54031-069-02) 48.19 g 2021-06-15 No No Current