Home NDC 53634-153 salicylic gel
Product NDC 53634-153
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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53634-153-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53634-153-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53634-153-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53634-153-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53634-153-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53634-153-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53634-153-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53634-153-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53634-153-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53634-153-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53634-153-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53634-153-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53634-153-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53634-153-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53634-153-01 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 9 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rugby Benzoyl Peroxide Wash Acne Medication BENZOYL PEROXIDE Guangzhou Danting Bath&Body Care Industry Co. Ltd 4f0bb7c0-3c08-02cd-e063-6294a90a6749 2026-04-09 Warnings Exact identifier application number: M006 Rugby Benzoyl Peroxide Acne Medication BENZOYL PEROXIDE Guangzhou Danting Bath&Body Care Industry Co. Ltd 4f0bb38a-765b-d072-e063-6294a90a8d4d 2026-04-09 Warnings Exact identifier application number: M006 ageLOC LumiSpa Treatment Cleanser Acne SALICYLIC ACID NSE Products, Inc 7f478ae8-8b97-4cdf-a023-cea14b992ff9 2026-04-03 Warnings Exact identifier application number: M006 Anew Bare Acne Clearing Treatment 2% Salicylic Acid SALICYLIC ACID THE AVON COMPANY 4e7d1429-0498-5812-e063-6394a90a4d4d 2026-04-02 Warnings Exact identifier application number: M006 UNBLEMISH 30-Day Regimen SALICYLIC ACID, BENZOYL PEROXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE Rodan & Fields e9a52ccc-6ba0-4417-86cc-b2116a5b8d26 2026-04-01 Warnings Exact identifier application number: M006 ageLOC LumiSpa Blemish Serum SALICYLIC ACID NSE Products, Inc. 35cdc16c-9a51-4ee9-b39d-36f29c4176ae 2026-04-01 Warnings Exact identifier application number: M006 UNBLEMISH Refining Acne Wash SALICYLIC ACID Rodan & Fields 08922efa-5a90-4dfb-b9f4-a6c4f8dba3c9 2026-03-31 Warnings Exact identifier application number: M006 purity made simple SALICYLIC ACID Philosophy, Inc. ed785dc1-a1a2-4e89-a4f7-2d0eef3ca2bb 2026-03-31 Warnings Exact identifier application number: M006 UNBLEMISH Dual Intensive Acne Treatment BENZOYL PEROXIDE Rodan & Fields 27ea743c-e080-487d-adc5-e31176f5b9fc 2026-03-30 Warnings Exact identifier application number: M006 SPESOLSKII MILIA REMOVER ESSENCE SALICYLIC ACID 1% MILIA REMOVER ESSENCE BEST GREEN LIMITED 4e35f848-2e9c-d0c6-e063-6294a90a8d4b 2026-03-29 Warnings Exact identifier application number: M006 Purito Acne Intensive Treatment SALICYLIC ACID Hinature Inc. ca5ab57f-ddcb-4ced-8dd3-a698ad2d17de 2026-03-26 Warnings Exact identifier application number: M006 Oxy Vitamin C Serum SALICYLIC ACID 0.5% The Mentholatum Company 2a34ceef-d442-1c2d-e063-6294a90a6639 2026-03-25 Warnings Exact identifier application number: M006 Oxy Sensitive Skin Acne Cream Cleanser BENZOYL PEROXIDE 5% The Mentholatum Company 288da995-eda8-5d1c-e063-6394a90a38b2 2026-03-25 Warnings Exact identifier application number: M006 Oxy Deep Pore Acne Cleansing Pads SALICYLIC ACID The Mentholatum Company 4dde8b03-84e2-5ec7-e063-6394a90a6910 2026-03-25 Warnings Exact identifier application number: M006 Rael Beauty Miracle Clear Complete Acne Serum SALICYLIC ACID Rael, Inc. fdb7ecd2-c4c8-90b6-e053-6294a90a69b1 2026-03-25 Warnings Exact identifier application number: M006 JTOPYRT SALICYLIC ACID PAD Guangzhou Yixiang Trading Co., Ltd. 3dfb8f94-f734-de7d-e063-6394a90abed8 2026-03-25 Warnings Exact identifier application number: M006 Tula Skincare Clear Skin Starters Travel Size Acne and Blemish Fighting Kit SALICYLIC ACID The Procter & Gamble Manufacturing Company 4dc9e3eb-c4d0-b5e1-e063-6394a90a9b7e 2026-03-24 Warnings Exact identifier application number: M006 Oxy 3-IN-1 Acne Cleansing Pads SALICYLIC ACID The Mentholatum Company 4dcc9f0a-24d0-d62e-e063-6394a90aafe2 2026-03-24 Warnings Exact identifier application number: M006 WHAMISA ORGANIC PEAR BLOSSOM SUNSCREEN ZINC OXIDE ENS KOREA Co., Ltd. 34f9688d-efa1-1d3f-e063-6294a90ab127 2026-03-23 Warnings Exact identifier application number: M006 Flobow FACIAL BUMP REFINING ESSENCE SALICYLIC ACID 1% FACIAL BUMP REFINING ESSENCE Jiangxi Yudexi Pharmaceutical Co., LTD 4d6fb8af-5641-4a9a-e063-6294a90abfa9 2026-03-20 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