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 51 of 54 · 1,079 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Differin Acne Clearing Body SALICYLIC ACID Galderma Laboratories, L.P. ce4d1074-5f74-4ad7-9535-2737f5fff24f 2023-12-11 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm Phytoaction Acne Control Daily Moisturizer SALICYLIC ACID L'Oreal USA Products Inc b7d0d094-6a5b-4776-9f13-1f8d30542476 2023-12-11 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm Phytoaction Deep Cleansing SALICYLIC ACID COSMETIQUE ACTIVE PRODUCTION b61a3f74-a588-47f4-b4a5-c8f97f98d9dd 2023-12-11 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm BHA Exfoliating Serum Acne Treatment SALICYLIC ACID L'Oreal USA Products Inc c6f5e9a4-c938-4c44-ace7-a9688b227d59 2023-12-11 Warnings Exact identifier application number: M006 Clarifying Toner SALICYLIC ACID Allure Labs 0c07e6e9-18c1-20da-e063-6294a90aa3c8 2023-12-08 Warnings Exact identifier application number: M006 Acne Advanced Clarifying Hydrator SALICYLIC ACID Eminence Organic Skin Care Ltd. b710cc36-f589-4116-a0a2-c6966ebebbf2 2023-12-08 Warnings Exact identifier application number: M006 Foaming Cleanser SALICYLIC ACID Allure Labs 0bf4c2d8-2fbf-a1c4-e063-6294a90ac130 2023-12-07 Warnings Exact identifier application number: M006 CLEAROGEN 3 BENZOYL PEROXIDE Allure Labs 0bdf9f38-5763-a4d0-e063-6394a90a41dc 2023-12-06 Warnings Exact identifier application number: M006 REPLENIX ACNE 10% WASH PARABEN FREE WITH ALOE BENZOYL PEROXIDE Topiderm, Inc. ea9a32c4-3795-4718-9394-bac69091c732 2023-12-04 Warnings Exact identifier application number: M006 Acne Advanced Treatment System SALICYLIC ACID Eminence Organic Skin Care Ltd. 9acf53a6-10f1-470d-b270-3a0203cf89c0 2023-12-02 Warnings Exact identifier application number: M006 Cetaphil Gentle Clear BPO Acne Cleanser BENZOYL PEROXIDE Galderma Laboratories, L.P. 6397f20f-d69f-47e4-a123-4cc7e1abfcad 2023-11-29 Warnings Exact identifier application number: M006 Acne Fighting Spot with Aloe clear SALICYLIC ACID Zhejiang Ayan Biotech Co.,Ltd. db0054b1-29b9-48fa-8a02-86683bae8134 2023-11-21 Warnings Exact identifier application number: M006 Cetaphil Gentle Clear Clarifying Acne Cleanser SALICYLIC ACID Galderma Laboratories, L.P. 9add83f2-7da6-4cd0-b91b-f6c937a56255 2023-11-20 Warnings Exact identifier application number: M006 Dr. Gross AB Acne Daily Breakout SALICYLIC ACID Topiderm, Inc 79d7f1f6-d08f-4be0-afc1-9ab4338a954d 2023-11-20 Warnings Exact identifier application number: M006 Dr. Dennis Gross Alpha Beta On the Spot Eliminator SALICYLIC ACID Topiderm, Inc e0dccdbc-56fd-4034-b479-f2a2ebde2234 2023-11-16 Warnings Exact identifier application number: M006 Cetaphil Gentle Clear Triple-Action Acne Serum SALICYLIC ACID Galderma Laboratories, L.P. 3e6eb59f-c523-460e-87ed-750b4a8cacac 2023-11-16 Warnings Exact identifier application number: M006 Medicated Wash SALICYLIC ACID Vivier Pharma, Inc. e90ab8b6-6a77-4e02-9d71-45cd7383cb0a 2023-11-14 Warnings Exact identifier application number: M006 GOODBYE ACNE Complete treatment gel SALICYLIC ACID Peter Thomas Roth, LLC 09b88031-f5fe-8ae1-e063-6394a90a8a6a 2023-11-14 Warnings Exact identifier application number: M006 L BRI Pure n Natural Deep Clean Toner SALICYLIC ACID L'BRI HEALTH AND BEAUTY INC 353e948e-da5d-4c15-adcb-77ef978cf05f 2023-11-11 Warnings Exact identifier application number: M006 MD-Acne Body Acne Treatment BENZOYL PEROXIDE MD Algorithms Inc. 97981e9b-d56a-42f6-a75f-647b4732021e 2023-11-11 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