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 45 of 54 · 1,079 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Replenix Gly-Sal 10-2 cleanser SALICYLIC ACID Topiderm, Inc. 00d1f8af-88de-4a14-80ec-5ee9fd38b191 2024-08-02 Warnings Exact identifier application number: M006 AL0076001 Alba Botanica Acnedote Deep Pore Wash SALICYLIC ACID The Hain Celestial Group, Inc. 6157c9c6-f252-5b49-e053-2991aa0ad8ed 2024-07-31 Warnings Exact identifier application number: M006 AL00761 Alba Botanica Acnedote Face and Body Scrub SALICYLIC ACID The Hain Celestial Group, Inc. c55efca6-5a5b-134b-e053-2a95a90a8245 2024-07-31 Warnings Exact identifier application number: M006 Gly-Sal 5-2 SALICYLIC ACID Topiderm, Inc. a75e4cee-678f-4e44-9e5e-bafae1c23f9b 2024-07-31 Warnings Exact identifier application number: M006 Face Reality Advanced Acne Med BENZOYL PEROXIDE Face Reality e1eb8496-0611-4dbc-befb-fb43ec164433 2024-07-26 Warnings Exact identifier application number: M006 Face Reality 5% Advanced Acne Med BENZOYL PEROXIDE Face Reality 0e52972d-b4d9-43f8-8dbb-2eec0782e0f7 2024-07-26 Warnings Exact identifier application number: M006 Face Reality 10% Advanced Acne Med BENZOYL PEROXIDE Face Reality a214ea15-6346-4729-ba84-fbc842faf92a 2024-07-26 Warnings Exact identifier application number: M006 Replenix Gly-Sal 2-2 SALICYLIC ACID Topiderm, Inc. 6c6bbedc-e2ee-46a0-8800-e356bdd262b0 2024-07-25 Warnings Exact identifier application number: M006 Thayers Since 1847 Natural Remedies Double Action Acne Serum SALICYLIC ACID L'Oreal USA Products Inc f9daadf9-a9d3-4f2d-af07-5f0b70f7803f 2024-07-17 Warnings Exact identifier application number: M006 BLEMISH DOTS - RETINOL (10 PATCHES) SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. c7164d75-75e7-494a-9595-028ecbf26276 2024-07-14 Warnings Exact identifier application number: M006 BLEMISH DOTS - CHARCOAL (10 PATCHES) SALICYLIC ACID 0.5% Ganzhou Olivee Cosmetic Co., Ltd. 286f642f-7359-41b9-9daf-e866a87fbefa 2024-07-14 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment SALICYLIC ACID L'Oreal USA Products Inc 74c49388-3314-47e8-80b1-19c09e6ea1f9 2024-07-14 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment SALICYLIC ACID COSMETIQUE ACTIVE PRODUCTION 873de079-8b8d-45cd-8c7c-4645818f5aaa 2024-07-14 Warnings Exact identifier application number: M006 Dr. Zenovia Clear Complexion SALICYLIC ACID Topiderm, Inc. 4ff9b26d-3cd9-4539-b389-edd2df24a466 2024-06-28 Warnings Exact identifier application number: M006 LEROSETT Botanical Acne Cleanser SALICYLIC ACID GUNILLA OF SWEDEN, INC. 8b31d155-c257-4452-9e22-0c69fa36173e 2024-06-27 Warnings Exact identifier application number: M006 SkinCeuticals Silymarin CF Acne Treatment Antioxidant SALICYLIC ACID Cosmetique Active Production fcc3c44b-3090-45b5-91e4-e591c92a08c8 2024-06-24 Warnings Exact identifier application number: M006 Peace Out Early Stage Acne Dot SALICYLIC ACID Peace Out LLC. 0632d458-d326-ade4-e063-6294a90af3ba 2024-06-20 Warnings Exact identifier application number: M006 Replenix BP Acne BENZOYL PEROXIDE Topiderm, Inc. f449e020-a4d8-4a1b-82eb-4dc59e99b8d4 2024-06-18 Warnings Exact identifier application number: M006 b pure Pressed Powder for Acne Prone Skin Fair SALICYLIC ACID Fourstar Group USA, Inc. ecf22bd1-4fc3-4455-ae01-13f97f53dc34 2024-06-17 Warnings Exact identifier application number: M006 b pure Pressed Powder for Acne Prone Skin Tan SALICYLIC ACID Fourstar Group USA, Inc. 1158f6c2-2b59-4ed3-8d28-73b6da885a5d 2024-06-17 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