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 50 of 54 · 1,079 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acne Med 5% BENZOYL PEROXIDE Face Reality, LLC 454983d2-4b11-6268-e054-00144ff8d46c 2023-12-15 Warnings Exact identifier application number: M006 Acne Face and Body Wash BENZOYL PEROXIDE Face Reality Skin Care, LLC 454983d2-4aec-6268-e054-00144ff8d46c 2023-12-15 Warnings Exact identifier application number: M006 Acne Med 2.5% BENZOYL PEROXIDE Face Reality, LLC 454983d2-4b0f-6268-e054-00144ff8d46c 2023-12-15 Warnings Exact identifier application number: M006 Nighttime Control BENZOYL PEROXIDE Circadia by Dr Pugliese, Inc. fb4cc832-4cfd-4e29-a78e-ab848681a224 2023-12-15 Warnings Exact identifier application number: M006 La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment SALICYLIC ACID L'Oreal USA Products Inc 5056320e-e472-44ed-9afd-759ba55f0fd7 2023-12-13 Warnings Exact identifier application number: M006 La Roche Posay Laboratoire Dermatologique Effaclar AntiAcne Pore Refining Acne Treatment SALICYLIC ACID COSMETIQUE ACTIVE PRODUCTION 418d480c-4131-4262-bb56-d5b10bbf7dcb 2023-12-13 Warnings Exact identifier application number: M006 Acne Advanced Clarifying Masque SALICYLIC ACID Eminence Organic Skin Care Ltd. 7916a299-fc90-4eb7-882f-4caa39e2c7aa 2023-12-12 Warnings Exact identifier application number: M006 Serious Skincare Continuously Clear Acne Medication For Problematic skin Dry Lo Pro All- Over Treatment SALICYLIC ACID Flageoli Limited eb57517c-cf9e-4272-9c00-380385f916e0 2023-12-12 Warnings Exact identifier application number: M006 111MedCo 6% Sulfur Skin Cleansing Bar SULFUR 111MedCo LLC 7a2d647f-f10f-4637-b28b-319fed93677b 2023-12-12 Warnings Exact identifier application number: M006 111MedCo 2% Salicylic Acid Cleansing Bar SALICYLIC ACID 111MedCo LLC 6ba7dd8f-b59f-4dfb-b55e-c7fe65a54d8a 2023-12-12 Warnings Exact identifier application number: M006 111 Medco Benzoyl Peroxide BENZOYL PEROXIDE 111 Medco 8590214e-e5a7-8934-e053-2a91aa0a248b 2023-12-12 Warnings Exact identifier application number: M006 MILANI ERASE BASE BLEMISH CONTROL PRIMER Salicylic Acid SALICYLIC ACID New Milani Group, LLC c2d43609-8a7a-4e54-8e8c-66115948dba2 2023-12-12 Warnings Exact identifier application number: M006 Differin Daily Deep Cleanser with BPO BENZOYL PEROXIDE Galderma Laboratories, L.P. 192b231b-51f1-457c-9a82-ef75671c0d34 2023-12-11 Warnings Exact identifier application number: M006 SkinCeuticals Silymarin CF Acne Treatment SALICYLIC ACID L'Oreal USA Products Inc aa439d77-7ba5-4699-8e8b-3bba35f5094d 2023-12-11 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm Acne Control Moisturizer SALICYLIC ACID COSMETIQUE ACTIVE PRODUCTION 04df2f5d-77f0-4553-9d8c-3f10628736ae 2023-12-11 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm Acne Control Daily Moisturizer SALICYLIC ACID L'Oreal USA Products Inc 4acae53c-3250-4703-83ac-f158562926c6 2023-12-11 Warnings Exact identifier application number: M006 Differin Acne Clearing Body Scrub SALICYLIC ACID Galderma Laboratories, L.P. b1e9f483-80ad-49f1-974e-4732bacd9639 2023-12-11 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm BHA Exfoliating Acne Treatment SALICYLIC ACID COSMETIQUE ACTIVE PRODUCTION a2369870-cf81-4ebd-a354-858212d67d0e 2023-12-11 Warnings Exact identifier application number: M006 Vichy Laboratoires Normaderm Phytoaction Daily Deep Cleansing SALICYLIC ACID L'Oreal USA Products Inc 0db3a8cb-7691-4772-9f7d-15de66098e2e 2023-12-11 Warnings Exact identifier application number: M006 Differin Acne Clearing Body Wash SALICYLIC ACID Galderma Laboratories, L.P. b280351f-02d4-4456-85b5-905e83596848 2023-12-11 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