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 3 of 56 · 1,101 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acne Free Free 24 HR Acne Clearing System BENZOYL PEROXIDE AcneFree, LLC c939847a-72eb-96fa-e053-2a95a90a4f9c 2026-07-31 Warnings Exact identifier application number: M006 Terminator 10 BENZOYL PEROXIDE AcneFree, LLC c06778b6-0ed6-7d82-e053-2a95a90a2ef8 2026-07-31 Warnings Exact identifier application number: M006 Acne Free Oil Free Acne Cleanser 2.5 Benzoyl Peroxide BENZOYL PEROXIDE AcneFree LLC c939847a-72cc-96fa-e053-2a95a90a4f9c 2026-07-31 Warnings Exact identifier application number: M006 Benzoyl Peroxide Deep Cleansing Foaming Wash BENZOYL PEROXIDE AcneFree, LLC fe2d0e24-8c68-b2ea-e053-6294a90ad72c 2026-07-31 Warnings Exact identifier application number: M006 Salicylic Acid SALICYLIC ACID Acne Free, LLC 1097fc73-fa47-0f14-e063-6294a90aa499 2026-07-31 Warnings Exact identifier application number: M006 Even and Clear Cleanser SALICYLIC ACID Ambi Enterprises LLC bff537cf-aa79-5250-e053-2995a90a388a 2026-07-31 Warnings Exact identifier application number: M006 Oil Free Deep Cleansing Duo Cleansing Brush Oil Free Acne Cleanser BENZOYL PEROXIDE AcneFree, LLC c7a675fa-b6c0-6237-e053-2a95a90a0406 2026-07-31 Warnings Exact identifier application number: M006 Acne Free SEVERE ACNE 24 HR Acne Clearing System BENZOYL PEROXIDE AcneFree, LLC c939681e-ea93-31ce-e053-2a95a90a8c70 2026-07-31 Warnings Exact identifier application number: M006 Acne Free SENSITIVE SKIN 24 HR Acne Clearing System SALICYLIC ACID, BENZOYL PEROXIDE AcneFree LLC c9397a25-8fed-48d0-e053-2a95a90ab495 2026-07-31 Warnings Exact identifier application number: M006 sulfur acne treatment SULFUR Acne Free 105545d8-974c-5a9a-e063-6294a90aecc4 2026-07-31 Warnings Exact identifier application number: M006 24 Hour Sensitive Skin Acne Clearing System SALICYLIC ACID Acne Free LLC 39ea674d-ff6e-a8c6-e063-6394a90a0656 2026-07-31 Warnings Exact identifier application number: M006 cardae FOLLICULITIS Cream MICONAZOLE NITRATE 2% FOLLICULITIS CREAM Wenzhou Yuyuan Pharmaceutical Co., Ltd. 57e0be6a-3141-f3b6-e063-6394a90a1520 2026-07-30 Warnings Exact identifier application number: M006 SKINTIFIC 3X ACID INTENSIVE ACNE TREATMENT SALICYLIC ACID Gold Inti Trade Corporation 57a7c929-31f5-ef82-e063-6394a90ab9af 2026-07-28 Warnings Exact identifier application number: M006 Acne Treatment with Sulfur SULFUR DLC Laboratories, Inc. 4a1591e8-6135-4b22-b54c-5553c2dc0540 2026-07-28 Warnings Exact identifier application number: M006 amberglow BLEMISH PATCHES SALICYLIC ACID Pearl World Inc. 12054430-25ff-4b72-8f64-822b27abb443 2026-07-27 Warnings Exact identifier application number: M006 RFA BPO Acne Treatment 2.5% BENZOYL PEROXIDE Topiderm, Inc. c5053e9e-7608-45d9-9b9b-9b93210eb917 2026-07-27 Warnings Exact identifier application number: M006 ACNO Solution ACNE TREATMENT SALICYLIC ACID Noon Aesthetics M.R. Ltd 4a267e44-03d9-471f-9708-a5c60ff69097 2026-07-24 Warnings Exact identifier application number: M006 DERMFREE MILIA REMOVER SALICYLIC ACID 1% MILIA REMOVER Jiangxi Yudexi Pharmaceutical Co., LTD 4a5c8a6e-b02d-3a87-e063-6294a90a14ff 2026-07-23 Warnings Exact identifier application number: M006 salicylic acid SALICYLIC ACID Chain Drug Marketing Association 4dc96074-50a1-baa8-e063-6294a90a5aab 2026-07-22 Warnings, Adverse reactions Exact identifier application number: M006 SYLVIRENE MILIA REMOVER SALICYLIC ACID 1% MILIA REMOVER Jiangxi Yudexi Pharmaceutical Co., LTD 4a3751f8-2365-1b34-e063-6394a90acf74 2026-07-21 Warnings Exact identifier application number: M006
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