SALICYLIC ACID

Product NDC
54295-302
11-digit product format
542950302
Labeler code
54295
Product ID
54295-302_aa82c73c-e094-46a9-9d16-4a1201d4857b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
CREAM
Route
TOPICAL
Labeler
Trinity Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2012-12-10
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
60 mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct54295-302IInactivated by FDA2026-09-14
excluded packagepackage54295-30254295-302-21IInactivated by FDA2026-09-14

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 · 14 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 packagepackage54295-302-21fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54295-302-2186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54295-302-21bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage54295-302-218dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54295-302-21e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54295-302-219bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage54295-302-21110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54295-302-21SALICYLIC ACID1 in 1 CARTONCREAM12
54295-302-21SALICYLIC ACID454 g in 1 BOTTLECREAM4542

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54295-302-21GM - Gram54295-302b13ca75d-60e3-4731-8589-cc0cdf6a68d412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
AMMONIUM LACTATEINACTIVE INGREDIENT67M901L9NQSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
DIMETHICONE 350INACTIVE INGREDIENT2Y53S6ATLUSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
DISTEAROYLETHYL HYDROXYETHYLMONIUM METHOSULFATEINACTIVE INGREDIENTG52U8T64UMSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
GLYCERYL 1-STEARATEINACTIVE INGREDIENT258491E1RZSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
TRIETHYLENE GLYCOLINACTIVE INGREDIENT3P5SU53360SALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RSALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54295-302SALICYLIC ACID CREAM [TRINITY PHARMACEUTICALS, LLC]2Legacy NDC, 2 package rows20230323_e615b9e7-af48-481c-841d-41cbc0673c7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477031salicylic acid 6 % Topical CreamPSNe615b9e7-af48-481c-841d-41cbc0673c7d2
477031salicylic acid 60 MG/ML Topical CreamSCDe615b9e7-af48-481c-841d-41cbc0673c7d2
477031salicylic acid 6 % Topical CreamSYe615b9e7-af48-481c-841d-41cbc0673c7d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54295-302-21542950302211 in 1 CARTONHistorical