FDA.reportPublic FDA data

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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53634-15353634-153-01IInactivated by FDA2026-10-21

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53634-153-012024-01-30C16284748780-11030e365-6797-111a-e063-dadaa90a10e2salicylic gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53634-153-01salicylic gel15 mL in 1 TUBEGEL151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53634-153SALICYLIC GEL (SALICYLIC ACID) GEL [MALIN AND GOETZ INC]1Legacy NDC, 1 package rows20221202_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 44 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MDacne Body Acne Treatment Benzoyl PeroxideBENZOYL PEROXIDEMDAlgorithms Inc97529268-c45c-49c0-8eb0-15c90def69ea2024-09-19WarningsExact identifier
application number: M006
MDacne Customized Acne Cleanser Hydrating Salicylic AcidSALICYLIC ACIDMDAlgorithms Incff01a623-327d-4350-819f-68188c82b9122024-09-19WarningsExact identifier
application number: M006
Aveeno clear complexion daily moisturizerSALICYLIC ACIDKenvue Brands LLCc13dac31-bccb-4fcc-81c4-90e3e63ba59f2024-09-12WarningsExact identifier
application number: M006
MY BEAUTY SPOT Acne Care Patch KitSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.9bec6363-bc71-47fa-8732-33fa7cc58d6c2024-09-10WarningsExact identifier
application number: M006
Healing Acne Care Patches - Tea Tree and Vitamin ASALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.ad7e5be5-7e20-4616-8094-8dae43cfc0052024-09-10WarningsExact identifier
application number: M006
Healing Acne Care Patches - Tea Tree and Salicylic AcidSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.ec37a585-3adb-4829-93d1-7814adbdc0962024-09-10WarningsExact identifier
application number: M006
Spot Acne Treatment Oil Free 0.75ozSALICYLIC ACID CREAMChina Ningbo Shangge Cosmetics Technology Corp.21cedce7-61e0-6479-e063-6294a90abf5d2024-09-10WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEBryant Ranch Prepack4ea1d07e-b39f-4afb-85ae-0b3c544ac3c72024-09-06WarningsExact identifier
application number: M006
Spot Acne Treatment Oil Free 0.75ozSALICYLIC ACIDRejoice International Corp.212f77ca-82d3-6a78-e063-6394a90aed322024-09-02WarningsExact identifier
application number: M006
HEALING BLEMISH DOTSSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.4e62aee6-978d-4439-83cd-ee24882450e72024-08-28WarningsExact identifier
application number: M006
amazon basics step 3 treatment Acne medicationBENZOYL PEROXIDEAMAZON.COM SERVICES LLCe104ea51-816c-4565-a829-b03957d3d9622024-08-28WarningsExact identifier
application number: M006
amazon basics step 1 cleanser Acne treatmentBENZOYL PEROXIDEAMAZON.COM SERVICES LLC23a060f0-d379-4370-9a79-ca6e854419b42024-08-26WarningsExact identifier
application number: M006
SEYTU SpotSALICYLIC ACIDOmnilife USA, Inc.68252aa0-36cd-4380-8898-16a5e47318662024-08-23WarningsExact identifier
application number: M006
Peach Slices 3 Step Acne Starter KitSALICYLIC ACIDPeach & Lily, Inc0c8860ca-5376-4e98-a7a9-4668dff4f0aa2024-08-14WarningsExact identifier
application number: M006
PHARMA CLEAR CLEANSERSALICYLIC ACIDPHARMAGEL INTERNATIONAL INCd2c39d80-5ccd-43a8-a8bf-eba502bfdbf12024-08-13WarningsExact identifier
application number: M006
PHARMA CLEAR MOISTURIZERSALICYLIC ACIDPHARMAGEL INTERNATIONAL INCc4c08475-bafa-4bb1-92a5-e94e600862642024-08-13WarningsExact identifier
application number: M006
PHARMA CLEAR ACNE TREATMENTSALICYLIC ACIDPHARMAGEL INTERNATIONAL INC6d94f911-d751-45e4-b24d-8d85c6a3cefb2024-08-13WarningsExact identifier
application number: M006
Anti-Everything Face SerumSALICYLIC ACID SERUMBentley laboratories, llC8330e61c-50ec-44a5-91d9-a97e5a9d03882024-08-05WarningsExact identifier
application number: M006
Anti-Everything Face MoisturizerSALICYLIC ACID CREAMBentley Laboratories, LLC36cb28f2-2620-4b88-811f-a2d6c1e22e792024-08-05WarningsExact identifier
application number: M006
Tucks Medicated Cooling PadsWITCH HAZELBlistex Inc1eb3c742-7104-7b47-e063-6394a90a84ba2024-08-02WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
346298salicylic acid 2 % Topical GelPSNee2acdf0-e5dc-9691-e053-2995a90ab49e1
346298salicylic acid 0.02 MG/MG Topical GelSCDee2acdf0-e5dc-9691-e053-2995a90ab49e1
346298salicylic acid 2 % Topical GelSYee2acdf0-e5dc-9691-e053-2995a90ab49e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53634-153-015363401530115 mL in 1 TUBE (53634-153-01) 15 ml2022-11-230000-00-00NoNoCurrent