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 46 of 54 · 1,079 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gly-Sal 10-2 SALICYLIC ACID Topiderm, Inc. 661cc58b-9360-4b96-b405-afdc2e378397 2024-06-13 Warnings Exact identifier application number: M006 BLAIR and JACK Anti-Bump Acne Treatment BENZOYL PEROXIDE Blair + Jack aa8df86a-639c-4416-aadf-4b58566ed9f1 2024-06-11 Warnings Exact identifier application number: M006 b pure Blemish Concealer for Acne Prone Skin Nude SALICYLIC ACID Fourstar Group USA, Inc. 76e91277-1fb4-490b-b351-39d626bc1fc2 2024-06-11 Warnings Exact identifier application number: M006 b pure Blemish Concealer for Acne Prone Skin Fair SALICYLIC ACID Fourstar Group USA, Inc. 764599e5-2ec3-4223-819e-36415fd915f7 2024-06-11 Warnings Exact identifier application number: M006 Dr. Zenovia Acne Cleanser BENZOYL PEROXIDE Topiderm, Inc. 00fb1ee5-6076-4980-8507-9e58a96e6a6b 2024-06-11 Warnings Exact identifier application number: M006 Dr. Zenovia Spot Treatment BENZOYL PEROXIDE Topiderm, Inc. dfdb3d8e-4d39-4ce4-851f-80b11972ca9e 2024-06-11 Warnings Exact identifier application number: M006 Rugby Benzoyl Peroxide Acne Medication BENZOYL PEROXIDE NuCare Pharmaceuticals,Inc. 69bd4f4c-017a-7422-e053-2991aa0aa655 2024-06-10 Warnings Exact identifier application number: M006 Thayers Natural Remedies Since 1847 Rapid Acne Treatment SULFUR L'Oreal USA Products Inc d7cc3c06-2f89-4c0b-b121-fdd53638b625 2024-06-07 Warnings Exact identifier application number: M006 Differin 10% BPO Acne Treatment BENZOYL PEROXIDE Galderma Laboratories, L.P. 05468eab-f239-42cb-9106-055a105f0fa5 2024-06-06 Warnings Exact identifier application number: M006 2.5 Acne Med BENZOYL PEROXIDE Face Reality, Inc. 58a7f677-996c-4951-8e5d-b5556244f800 2024-06-05 Warnings Exact identifier application number: M006 10 Acne Med BENZOYL PEROXIDE Face Reality, Inc. 91791905-086f-44cf-9c1a-e9f132c6c11b 2024-06-05 Warnings Exact identifier application number: M006 Walgreens Oil-Free Acne Wash Salicylic Acid SALICYLIC ACID Walgreen Company 9f311567-caa2-4302-9cf8-8c341917d16e 2024-06-03 Warnings Exact identifier application number: M006 Walgreens Maximum Strength Acne Treatment Acne medication BENZOYL PEROXIDE Walgreen Company 72ca0ddd-9292-48c9-9189-532a1768c9b7 2024-06-03 Warnings Exact identifier application number: M006 Derma E Acne Matte Moisturizer SALICYLIC ACID derma e 48fd8477-b880-4a31-9227-095d38a7eac5 2024-05-31 Warnings Exact identifier application number: M006 LACTO-S ACNE TREATMENT SALICYLIC ACID Noon Aesthetics M.R. Ltd ea0c7fda-30a0-48df-8a1b-4d6098c0081e 2024-05-31 Warnings Exact identifier application number: M006 Derma E Acne Cleansing Pads SALICYLIC ACID derma e c749a11f-daa1-4d76-b818-cd6509efaceb 2024-05-28 Warnings Exact identifier application number: M006 ULTA All Clear SERUM SALICYLIC ACID APR BEAUTY GROUP INC 199a96c1-94b8-3de6-e063-6394a90ab478 2024-05-28 Warnings Exact identifier application number: M006 Crystal Clear Acne Treatment Pads SALICYLIC ACID Skin Pharm, LLC 0469b1ab-5cfb-416a-b34b-7dc6fef611ff 2024-05-22 Warnings Exact identifier application number: M006 Anti-Aging Blemish Control Peel Pads SALICYLIC ACID June Jacobs Labs, LLC 18fa83ab-1712-398c-e063-6394a90a6b79 2024-05-21 Warnings Exact identifier application number: M006 Peace Out Acne SALICYLIC ACID Peace Out LLC. efa796e8-62a8-6c20-e053-2a95a90aef6f 2024-05-20 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