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 19 of 56 · 1,101 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join clear days ahead oil-free salicylic acid acne treatment cleanser SALICYLIC ACID Philosophy Inc. e76dfe48-db23-47e9-8f86-640c9c7bc2a4 2025-12-17 Warnings Exact identifier application number: M006 clear days ahead oil-free salicylic acid acne treatment and moisturizer SALICYLIC ACID Philosophy Inc. d7895387-100c-4cc4-9c25-0f3b9d0f5937 2025-12-17 Warnings Exact identifier application number: M006 clear days ahead overnight repair salicylic acid acne treatment pads SALICYLIC ACID Philosophy Inc. 741c6f90-2e32-4700-bb9f-d30329bd3dc3 2025-12-17 Warnings Exact identifier application number: M006 clear days ahead fast-acting salicylic acid acne spot treatment SALICYLIC ACID Philosophy a61d0f78-9759-4085-b5e5-577d349be9fd 2025-12-17 Warnings Exact identifier application number: M006 Stage Fight Acne Mask SULFUR, RESORCINOL Bioelements, Inc 21ca8de4-28b5-425f-e063-6394a90a3340 2025-12-17 Warnings Exact identifier application number: M006 Spot Defy SULFUR Bioelements, Inc. 6f35f950-8d04-4181-a897-5679fde1e2d9 2025-12-17 Warnings Exact identifier application number: M006 BlemFree SALICYLIC ACID Equibal, Inc. d6720efc-dbbe-4304-bb31-972b506a08bf 2025-12-17 Warnings Exact identifier application number: M006 Blemfree SALICYLIC ACIDE Equibal, Inc. 424dba97-0d40-4801-9fec-4b80ab60f900 2025-12-17 Warnings Exact identifier application number: M006 Renu Laboratories Acne Sulphur L ACNE SULFUR LOTION Renu Laboratories, LLC 13de0e4c-b134-41c0-e054-00144ff88e88 2025-12-16 Warnings Exact identifier application number: M006 SUPER SPOT REMOVER ACNE TREATMENT SALICYLIC ACID ORIGINS NATURAL RESOURCES INC. a0aece76-008b-4af3-be39-13156acc73af 2025-12-15 Warnings Exact identifier application number: M006 DRx Blemish Clarifying Mask SULFUR Dr. Dennis Gross Skincare 7093a8d4-1910-4b23-9d88-d3398db0916a 2025-12-15 Warnings Exact identifier application number: M006 e.l.f. PLZ Clarify Facial Oil SALICYLIC ACID e.l.f. Cosmetics, Inc. 26cde11d-e05e-35a7-e063-6394a90a1fdf 2025-12-14 Warnings Exact identifier application number: M006 Image Clear Cell Acne Spot Treatment SALICYLIC ACID ACNE GEL Swiss-American CDMO, LLC f1b272ba-683e-4eff-a3ac-a046f547d5e5 2025-12-11 Warnings Exact identifier application number: M006 Dr Mellaxeen SKIN SAVER ACNE RELIEF Stick SALICYLIC ACID Longway Lab Inc. 45b85ebb-c00a-61df-e063-6294a90a11bc 2025-12-11 Warnings Exact identifier application number: M006 Dr.Mellaxeen SKIN SAVER DAILY ACNE ESSENTIALS Kit SALICYLIC ACID Longway Technology(Guangzhou)Co.,Ltd. 45b89790-1056-b6a2-e063-6294a90a6f66 2025-12-11 Warnings Exact identifier application number: M006 MULTI-ACTION CLEAR - ACNE CLEARING TREATMENT 2% SALICYLIC ACID SALICYLIC ACID StriVectin Operating Company, Inc. f1d93376-4fc2-751f-e053-2a95a90a6888 2025-12-09 Warnings Exact identifier application number: M006 PowerSpot Cleanse SULFUR Bluemercury 443ae172-bacd-4122-8d78-d2214bcb02fd 2025-12-09 Warnings Exact identifier application number: M006 GM COLLIN PURACNE SALICYLIC ACID Laboratoires Dermo-Cosmetik Inc. 2619cc3b-5246-4519-94c4-07e0338b273c 2025-12-09 Warnings Exact identifier application number: M006 Hero Cosmetics Pimple Correct Salicylic Acid Acne Treatment SALICYLIC ACID Church & Dwight Co., Inc. 869afe67-edae-4778-b990-08c2313d5aad 2025-12-05 Warnings Exact identifier application number: M006 XIMONTH Bee Venom All-In-One Cream SALICYLIC ACID Shantou Ximonth Biotechnology Co., Ltd. 451e2c76-dd85-7b04-e063-6294a90afad3 2025-12-04 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