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 34 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ALMAY CLEAR COMPLEXION MAKEUP FOUNDATION Caramel SALICYLIC ACID ALMAY 2a982e0e-4720-797e-e063-6294a90a43c1 2024-12-31 Warnings Exact identifier application number: M006 ALMAY CLEAR COMPLEXION MAKEUP FOUNDATION Mocha SALICYLIC ACID ALMAY 2a9807d1-cf87-7096-e063-6394a90afca3 2024-12-31 Warnings Exact identifier application number: M006 ALMAY CLEAR COMPLEXION MAKEUP FOUNDATION Natural Tan SALICYLIC ACID ALMAY 2a981e22-d7d1-311b-e063-6294a90ab25f 2024-12-31 Warnings Exact identifier application number: M006 ALMAY CLEAR COMPLEXION CONCEALER SALICYLIC ACID ALMAY c3b57024-120e-390f-e053-2a95a90a6d35 2024-12-30 Warnings Exact identifier application number: M006 Almay Clear Complexion Makeup Buff SALICYLIC ACID Almay 2a83300a-15f0-365a-e063-6394a90a28d1 2024-12-30 Warnings Exact identifier application number: M006 RETINOL CLEARING SALICYLIC ACID Dermalogica, LLC. 4c20d87c-f3cf-4a40-acec-b0a8bfb9b29c 2024-12-30 Warnings Exact identifier application number: M006 Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Balm SALICYLIC ACID L'Oreal USA Products Inc 0c902cfa-d98a-42c3-967b-5a7c51a65249 2024-12-30 Warnings Exact identifier application number: M006 Salicylic Acid Cleanser EXFOLIATING AND CLARIFYING FACE WASH Bentley Laboratories, LLC eb7fa2b5-3bdb-436c-8576-1eea29b8d1ff 2024-12-27 Warnings Exact identifier application number: M006 Acne Control Superclean Body Wash AHA BHA Formula SALICYLIC ACID Bentley Laboratories, LLC 16fd3343-d044-4f6b-af1a-30bc32ce2041 2024-12-27 Warnings Exact identifier application number: M006 SkinCeuticals Blemish Plus Age Defense Acne Treatment SALICYLIC ACID L'Oreal USA Products Inc 5726d12c-708c-46e6-a584-9e5c7a544fc8 2024-12-27 Warnings Exact identifier application number: M006 SkinCeuticals Clarifying Exfoliating Cleanser SALICYLIC ACID L'Oreal USA Products Inc a0cc4ae7-c266-4321-92e6-a46d560a74b2 2024-12-27 Warnings Exact identifier application number: M006 BRODA Acne SALICYLIC ACID Bentley Laboratories, LLC b7e1f105-8998-46a5-b1ae-85d21790b816 2024-12-27 Warnings Exact identifier application number: M006 Monat Be Clarified Acne-Clearing Moisturizer SALICYLIC ACID Cosmax Usa, Corporation 2984d615-7ed1-46c3-e063-6294a90a1f8a 2024-12-26 Warnings Exact identifier application number: M006 Nativae Milia Acne Serum SALICYLIC ACID CDE BRANDS LLC e04cf0a2-bda7-4e5b-9771-769995cf6925 2024-12-26 Warnings Exact identifier application number: M006 Milani Erase Base Blemish Control Primer SALICYLIC ACID Cosmax Usa, Corporation 1b1f1948-2ad9-48d2-9871-6830b2442f43 2024-12-26 Warnings Exact identifier application number: M006 Oxy Sensitive Skin Acne Cleansing Pads SALICYLIC ACID 0.5% The Mentholatum Company 2a36b6c5-f518-66f0-e063-6394a90acd40 2024-12-26 Warnings Exact identifier application number: M006 Oxy Deep Pore Acne Cleansing Pads SALICYLIC ACID 2% The Mentholatum Company 2a385fac-399b-c111-e063-6394a90aefc3 2024-12-26 Warnings Exact identifier application number: M006 Oxy 3-IN-1 Acne Cleansing Pads SALICYLIC ACID 2% The Mentholatum Company 2a398c8d-09e6-513b-e063-6294a90ad857 2024-12-26 Warnings Exact identifier application number: M006 DEEP ACNE SULFUR Dermalogica, LLC. d4e9d230-2ee4-4cc7-a7c9-a7dde50b6f40 2024-12-26 Warnings Exact identifier application number: M006 SUNDAY RILEY SATURN SULFUR ACNE SPOT TREATMENT MASK SULFUR Sunday Riley Modern Skincare, LLC 35364a71-b011-42f5-9941-4a2f8440808b 2024-12-26 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