FDA.reportPublic FDA data

Salicylic Acid

Product NDC
42546-270
Requested package NDC
42546-270-01
11-digit product format
425460270
Labeler code
42546
Product ID
42546-270_3ee9ee78-76b5-450c-9211-4c0574b9959e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Salicylic Acid
Dosage form
KIT
Labeler
PruGen, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-05-01
Marketing end
0000-00-00
Active strength
0
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 packagepackage42546-27042546-270-01IInactivated by FDA2026-10-15

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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42546-270-012024-01-30C16284748780-11030e365-6a4a-111a-e063-dadaa90a10e2Salicylic Acid 6% Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42546-270-01Salicylic Acid1 in 1 BOXKIT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42546-270-01EA - Each42546-2706d9c0c93-fb9e-4941-9fd4-51d113b4317912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZSALICYLIC ACID CREAM [PRUGEN, INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZSALICYLIC ACID CREAM [PRUGEN, INC.]1
AMMONIUM LACTATEINACTIVE INGREDIENT67M901L9NQSALICYLIC ACID CREAM [PRUGEN, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSALICYLIC ACID CREAM [PRUGEN, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSALICYLIC ACID CREAM [PRUGEN, INC.]1
DIMETHICONE 350INACTIVE INGREDIENT2Y53S6ATLUSALICYLIC ACID CREAM [PRUGEN, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSALICYLIC ACID CREAM [PRUGEN, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSALICYLIC ACID CREAM [PRUGEN, INC.]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785ISALICYLIC ACID CREAM [PRUGEN, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSALICYLIC ACID CREAM [PRUGEN, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSALICYLIC ACID CREAM [PRUGEN, INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSALICYLIC ACID CREAM [PRUGEN, INC.]1
PEG-3 DISTEAROYLAMIDOETHYLMONIUM METHOSULFATEINACTIVE INGREDIENT395MHJ5PURSALICYLIC ACID CREAM [PRUGEN, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSALICYLIC ACID CREAM [PRUGEN, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MSALICYLIC ACID CREAM [PRUGEN, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSALICYLIC ACID CREAM [PRUGEN, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSALICYLIC ACID CREAM [PRUGEN, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSALICYLIC ACID CREAM [PRUGEN, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42546-270SALICYLIC ACID KIT [PRUGEN, INC.]7Legacy NDC, 1 package rows20220122_99d7e2ad-2dc3-4177-80eb-137715855b8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477031salicylic acid 6 % Topical CreamPSN99d7e2ad-2dc3-4177-80eb-137715855b8a7
477031salicylic acid 60 MG/ML Topical CreamSCD99d7e2ad-2dc3-4177-80eb-137715855b8a7
477031salicylic acid 6 % Topical CreamSY99d7e2ad-2dc3-4177-80eb-137715855b8a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42546-270-01425460270011 KIT in 1 BOX (42546-270-01) * 454 g in 1 JAR * 355 g in 1 BOTTLE1 kit2011-05-010000-00-00NoNoCurrent