Home NDC 80489-300-01 Drs. ACNE CLEAR
Product NDC 80489-300
Requested package NDC 80489-300-01
11-digit product format 804890300
Labeler code 80489
Product ID 80489-300_2b5291da-1ca7-db24-e063-6394a90a0721
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 5 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
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 CLEAR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID 5 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 252296 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80489-300-01 Drs. ACNE CLEAR 1 in 1 CARTON GEL 1 12 80489-300-01 Drs. ACNE CLEAR 20 g in 1 TUBE, WITH APPLICATOR GEL 20 12 80489-300-02 Drs. ACNE CLEAR 30 g in 1 TUBE, WITH APPLICATOR GEL 30 12 80489-300-02 Drs. ACNE CLEAR 1 in 1 CARTON GEL 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80489-300 DRS. ACNE CLEAR (SALICYLIC ACID) GEL [OL PHARMA TECH, LLC DRS. PHARMACY] 12 Current NDC, Legacy NDC, 4 package rows 20250112_d6faa57c-d081-b57c-e053-2a95a90a7926.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 28 of 54 · 1,079 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 80489-300-01 80489030001 1 TUBE, WITH APPLICATOR in 1 CARTON (80489-300-01) / 20 g in 1 TUBE, WITH APPLICATOR 2022-02-01 0000-00-00 No No Current