FDA.reportPublic FDA data

Salicylic Acid

Product NDC
55301-875
11-digit product format
553010875
Labeler code
55301
Product ID
55301-875_b2f4952a-7af1-413d-8068-14b0775eca85
Type
HUMAN OTC DRUG
Nonproprietary name
Astringent
Dosage form
LIQUID
Route
TOPICAL
Labeler
Your Military Exchanges
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-06-05
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
5 mg/mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55301-875DDiscontinued by firm2026-10-05
excluded packagepackage55301-87555301-875-34DDiscontinued by firm2026-10-05

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55301-875-34fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55301-875-3486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55301-875-34bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55301-875-342022-10-06C16284748780-1d6a99b39-8ba8-a426-e053-dadaa90af4c2Exchange Select 875.002/875AE Astringent
55301-875-342022-01-28C16284748780-1d6a99b39-8ba8-a426-e053-dadaa90af4c2Exchange Select 875.002/875AE Astringent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55301-875-34Salicylic Acid237 mL in 1 BOTTLE, PLASTICLIQUID23710

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-875SALICYLIC ACID (ASTRINGENT) LIQUID [YOUR MILITARY EXCHANGES]8Legacy NDC, 1 package rows20240918_d571573f-4100-454c-a1ee-36a155f1b44c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199308salicylic acid 0.5 % Topical SolutionPSNd571573f-4100-454c-a1ee-36a155f1b44c10
199308salicylic acid 5 MG/ML Topical SolutionSCDd571573f-4100-454c-a1ee-36a155f1b44c10
199308salicylic acid 0.5 % Topical SolutionSYd571573f-4100-454c-a1ee-36a155f1b44c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-875-3455301087534237 mL in 1 BOTTLE, PLASTIC (55301-875-34) 237 ml2009-06-050000-00-00NoNoCurrent