Home NDC 80489-357-01 Drs. ACNE SPOT TREATMENT
Product NDC 80489-357
Requested package NDC 80489-357-01
11-digit product format 804890357
Labeler code 80489
Product ID 80489-357_56368d1e-55eb-bf6c-e063-6294a90a4a90
Type HUMAN OTC DRUG
Nonproprietary name SALICYLIC ACID
Dosage form GEL
Route TOPICAL
Labeler OL PHARMA TECH, LLC Drs. PHARMACY
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-02-01
Substance SALICYLIC ACID
Active strength 20 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 Drs. ACNE SPOT TREATMENT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID 20 mg/g
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80489-357-01 Drs. ACNE SPOT TREATMENT 1 in 1 CARTON GEL 1 2 80489-357-01 Drs. ACNE SPOT TREATMENT 20 g in 1 TUBE, WITH APPLICATOR GEL 20 2 80489-357-02 Drs. ACNE SPOT TREATMENT 1 in 1 CARTON GEL 1 2 80489-357-02 Drs. ACNE SPOT TREATMENT 30 g in 1 TUBE, WITH APPLICATOR GEL 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80489-357 DRS. ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [OL PHARMA TECH, LLC DRS. PHARMACY] 2 Current NDC, 4 package rows 20240417_161b2306-364a-e1b8-e063-6394a90a6c88.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 18 of 56 · 1,101 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 80489-357-01 80489035701 1 TUBE, WITH APPLICATOR in 1 CARTON (80489-357-01) / 20 g in 1 TUBE, WITH APPLICATOR 2024-04-13 No No Current