Home NDC 53634-153-01 salicylic gel
Product NDC 53634-153
Requested package NDC 53634-153-01
11-digit product format 536340153
Labeler code 53634
Product ID 53634-153_ee2acdf0-e5dd-9691-e053-2995a90ab49e
Type HUMAN OTC DRUG
Nonproprietary name Salicylic Acid
Dosage form GEL
Route TOPICAL
Labeler Malin and Goetz Inc
Application M006
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-11-23
Marketing end 0000-00-00
Substance SALICYLIC ACID
Active strength 2 g/100mL
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 53634-153-01 salicylic gel 15 mL in 1 TUBE GEL 15 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53634-153 SALICYLIC GEL (SALICYLIC ACID) GEL [MALIN AND GOETZ INC] 1 Legacy NDC, 1 package rows 20221202_ee2acdf0-e5dc-9691-e053-2995a90ab49e.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 47 of 54 · 1,079 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Peace Out Acne SALICYLIC ACID Peace Out LLC. eac771e2-4c1a-3808-e053-2995a90ac5fc 2024-05-20 Warnings Exact identifier application number: M006 Cetaphil Gentle Clear Pore Clearing Acne Cleanser SALICYLIC ACID Galderma Laboratories, L.P. fc3abc75-5d9a-4b77-9b61-e6beba8a5cfe 2024-05-09 Warnings Exact identifier application number: M006 Walgreens Creamy Acne Face Wash Acne Medication BENZOYL PEROXIDE Walgreen Company 13e5396b-839b-4c08-a98f-f0a36c9a0bff 2024-05-09 Warnings Exact identifier application number: M006 Bubble Knock Out Acne Spot Treatment SALICYLIC ACID BUBBLE BEAUTY 17cf44cf-55f1-86a5-e063-6294a90a35d2 2024-05-06 Warnings Exact identifier application number: M006 Bubble Super Clear Blemish Prevention Serum SALICYLIC ACID BUBBLE BEAUTY 1790ad12-c947-ddc0-e063-6394a90a8569 2024-05-03 Warnings Exact identifier application number: M006 Walgreens Daily Acne Cleanser- Sensitive Skin Formula BENZOYL PEROXIDE Walgreen Company acae5006-e647-4f00-b93a-2c0bceee14cb 2024-05-01 Warnings Exact identifier application number: M006 Derma E Acne Blemish Control Treatment Serum SALICYLIC ACID derma e bf5f489d-07c6-47b8-ae76-701e7ad92e8d 2024-04-30 Warnings Exact identifier application number: M006 Pacifica Clear Mist Facial Acne SALICYLIC ACID Pacifica Beauty, LLC 16ee1a80-d523-1d02-e063-6394a90a9459 2024-04-25 Warnings Exact identifier application number: M006 Benzoyl Peroxide BENZOYL PEROXIDE Burel Pharmaceuticals, LLC 0617d42d-511d-4c1a-a919-b37abbc14efc 2024-04-24 Warnings Exact identifier application number: M006 Blemish Dots SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. f3cd004d-32f1-4888-8129-d355a4750b25 2024-03-24 Warnings Exact identifier application number: M006 Lacura Blemish Dots Conceal and Treat SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. 15c447b5-0e51-43e7-b697-683bc0e686c0 2024-03-20 Warnings Exact identifier application number: M006 My Beauty Spot Acne Buster SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. c61e100b-a141-45b3-842b-855be28b0226 2024-03-20 Warnings Exact identifier application number: M006 My Beauty Spot Acne Buster SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. f5c5a2df-11c5-4134-bf1f-b50564216449 2024-03-20 Warnings Exact identifier application number: M006 Blemish Control Dots aloe vera SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. 4722ff71-7d9f-4ef2-9f8b-3614e80b864f 2024-03-20 Warnings Exact identifier application number: M006 Blemish Control Dots SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. dc5410d0-d9f0-4ea4-b587-8bdfc39ac92b 2024-03-20 Warnings Exact identifier application number: M006 Blemish Dots SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. ca0e6b50-2995-41f8-b944-9f166aac0511 2024-03-13 Warnings Exact identifier application number: M006 Maximum Sterngth Cleansing Pads Equate SALICYLIC ACID Walmart 7db929b6-6470-4840-b016-7e19688548dd 2024-03-11 Warnings Exact identifier application number: M006 Acne Body Wash SALICYLIC ACID Rejoice International 97369cca-735a-425f-a0bc-00bc07691465 2024-02-28 Warnings Exact identifier application number: M006 Oil-Free Foaming Acne Wash Facial Cleanser Grapefruit SALICYLIC ACID Rejoice International a31baa57-1dfd-44d6-87a5-1b06377cb8b9 2024-02-28 Warnings Exact identifier application number: M006 Oil-Free Foaming Acne Wash Facial Cleanser Tea Tree Oil SALICYLIC ACID Rejoice International 7ae434d1-8b07-4121-9163-df07598d4156 2024-02-28 Warnings Exact identifier application number: M006
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53634-153-01 53634015301 15 mL in 1 TUBE (53634-153-01) 15 ml 2022-11-23 0000-00-00 No No Current