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 FDA2026-10-20

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 17 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO WASO KOSHIRICE ACNE CALMING TREATMENTSALICYLIC ACIDSHISEIDO AMERICAS CORPORATION3b584705-21a8-4e37-96cc-f9c8058db5c42026-01-05WarningsExact identifier
application number: M006
I DEW CARE CLEAN ZIT AWAY ACNE FOAMING CLEANSERSALICYLIC ACIDMemebox Corporation297bbe36-23be-0995-e063-6294a90a98df2026-01-01WarningsExact identifier
application number: M006
Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment MaskBENZOYL PEROXIDECosco International, Inc.6d7fd1ce-2155-4aa4-87c6-c6fc0c0d3f422026-01-01WarningsExact identifier
application number: M006
Acne Treatment GelSALICYLIC ACIDS+688783fd-574e-40dd-a4cb-c59afdebcddc2025-12-31WarningsExact identifier
application number: M006
Sei Bella Clarity Clear Acne All-Over Clearing Serum Cleansing SerumSALICYLIC ACIDMelaleuca, Inc.19266ab3-54cd-225d-e063-6294a90aa5122025-12-31WarningsExact identifier
application number: M006
Clarity Clear Skin Solutions Acne Spot TreatmentBENZOYL PEROXIDEMelaleuca, Inc.193667e8-3a4d-9270-e063-6294a90a1c262025-12-31WarningsExact identifier
application number: M006
Sei Bella Clarity Clear Refining Foaming Cleanser Acne treatmentSALICYLIC ACIDMelaleuca, Inc.19370e9a-4907-2ddc-e063-6294a90a97112025-12-31WarningsExact identifier
application number: M006
CLEAR MED 10%BENZOYL PEROXIDECONTROL CORRECTIVE SKINCARE INC7acd1404-2af7-4ec4-b1e9-a905c9f823b82025-12-31WarningsExact identifier
application number: M006
CLEAR MED 5%BENZOYL PEROXIDECONTROL CORRECTIVE SKINCARE INC03799b2c-cab1-4672-9004-29e4873d022f2025-12-31WarningsExact identifier
application number: M006
SALICYLIC WASHSALICYLIC ACIDCONTROL CORRECTIVE SKINCARE INC3c6fee91-6f02-40b6-b71f-495b4f235d172025-12-31WarningsExact identifier
application number: M006
SULFUR CALMING MASKSULFURCONTROL CORRECTIVE SKINCARE INC446bd2ea-da88-422a-b086-e61b2d5b62692025-12-31WarningsExact identifier
application number: M006
ACNE SPOT TREATMENTSALICYLIC ACIDCONTROL CORRECTIVE SKINCARE INC11d47f80-02ae-44a6-acf1-3babb762967b2025-12-31WarningsExact identifier
application number: M006
EXFO TONIC ACNE TREATMENTSALICYLIC ACIDCONTROL CORRECTIVE SKINCARE INC782867ee-8e38-42fc-bd31-c16e618b01d22025-12-31WarningsExact identifier
application number: M006
THYLOXSULFURBradford Soap Works, Inc.5f52b769-9893-4391-b98f-3765e7b494852025-12-31WarningsExact identifier
application number: M006
AVEDA OUTER PEACE ACNE RELIEF PADSSALICYLIC ACIDAveda Corporationc37052cc-6705-48ff-adf1-0dec7d7360072025-12-31WarningsExact identifier
application number: M006
Acne Care Charcoal CleanserACNE CARE CHARCOAL CLEANSERWhole Foods Market891c09a1-116b-3afd-e053-2995a90a856c2025-12-30WarningsExact identifier
application number: M006
Acne Care MoisturizerACNE CARE MOISTURIZERWhole Foods Market8957fab8-ec9c-2494-e053-2995a90a6c292025-12-30WarningsExact identifier
application number: M006
Body Acne TreatmentBODY SPRAYSkin PS Brands099ddba5-8e34-1e11-e063-6294a90af4c02025-12-30WarningsExact identifier
application number: M006
Salicylic Acid CleanserEXFOLIATING AND CLARIFYING FACE WASHSkin PS Brandsfb230cde-b225-6df6-e053-6294a90aa6532025-12-30WarningsExact identifier
application number: M006
BP Acne Spot TreatmentACNE SPOT TREATMENTSkin PS Brandsfeb0ed89-878b-2497-e053-6394a90ad1c12025-12-30WarningsExact 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