Salicylic Acid 6 percent

Product NDC
42546-279
11-digit product format
425460279
Labeler code
42546
Product ID
42546-279_45777b6d-68da-4e50-9613-dfeb5633d965
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Salicylic Acid
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
PruGen LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-01-01
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
6 mg/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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42546-279IInactivated by FDA2026-10-05
excluded packagepackage42546-27942546-279-06IInactivated by FDA2026-10-05

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42546-279-06IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42546-279-06IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42546-279-06IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42546-279-06IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42546-279-06IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42546-279-06IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42546-279-06UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42546-279-06UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42546-279-06UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42546-279-06Salicylic Acid 6 percent177 mL in 1 BOTTLESHAMPOO1774
42546-279-06Salicylic Acid 6 percent1 in 1 BOXSHAMPOO14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42546-279-06ML - Milliliter42546-279c19f31f1-7b8c-4699-9db1-73689f2ea00612013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
salicylic acidACTIVE INGREDIENTO414PZ4LPZSALICYLIC ACID 6 PERCENT (SALICYLIC ACID) SHAMPOO [PRUGEN, INC.]1
salicylic acidACTIVE MOIETYO414PZ4LPZSALICYLIC ACID 6 PERCENT (SALICYLIC ACID) SHAMPOO [PRUGEN, INC.]1
BEHENTRIMONIUM METHOSULFATEINACTIVE INGREDIENT5SHP745C61SALICYLIC ACID 6 PERCENT (SALICYLIC ACID) SHAMPOO [PRUGEN, INC.]1
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LSALICYLIC ACID 6 PERCENT (SALICYLIC ACID) SHAMPOO [PRUGEN, INC.]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XSALICYLIC ACID 6 PERCENT (SALICYLIC ACID) SHAMPOO [PRUGEN, INC.]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXSALICYLIC ACID 6 PERCENT (SALICYLIC ACID) SHAMPOO [PRUGEN, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSALICYLIC ACID 6 PERCENT (SALICYLIC ACID) SHAMPOO [PRUGEN, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSALICYLIC ACID 6 PERCENT (SALICYLIC ACID) SHAMPOO [PRUGEN, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSALICYLIC ACID 6 PERCENT (SALICYLIC ACID) SHAMPOO [PRUGEN, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSALICYLIC ACID 6 PERCENT (SALICYLIC ACID) SHAMPOO [PRUGEN, INC.]1
QUATERNIUM-22INACTIVE INGREDIENTMXO138JCBPSALICYLIC ACID 6 PERCENT (SALICYLIC ACID) SHAMPOO [PRUGEN, INC.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0SALICYLIC ACID 6 PERCENT (SALICYLIC ACID) SHAMPOO [PRUGEN, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSALICYLIC ACID 6 PERCENT (SALICYLIC ACID) SHAMPOO [PRUGEN, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RSALICYLIC ACID 6 PERCENT (SALICYLIC ACID) SHAMPOO [PRUGEN, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42546-279SALICYLIC ACID 6 PERCENT (SALICYLIC ACID) SHAMPOO [PRUGEN LLC]4Legacy NDC, 2 package rows20220203_b66252b0-84b5-45fc-a5f4-fd35dd341e73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
667904salicylic acid 6 % Medicated ShampooPSNb66252b0-84b5-45fc-a5f4-fd35dd341e734
667904salicylic acid 60 MG/ML Medicated ShampooSCDb66252b0-84b5-45fc-a5f4-fd35dd341e734
667904salicylic acid 6 % Medicated ShampooSYb66252b0-84b5-45fc-a5f4-fd35dd341e734

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42546-279-06425460279061 BOTTLE in 1 BOX (42546-279-06) > 177 mL in 1 BOTTLE1 bottle2009-01-010000-00-00NoNoCurrent