Salex

Product NDC
13548-011
11-digit product format
135480011
Labeler code
13548
Product ID
13548-011_417d7527-db4c-4925-b456-18e3ab94922a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Salicylic acid
Dosage form
LOTION
Route
TOPICAL
Labeler
Coria Laboratories
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2004-10-01
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
60 mg/mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct13548-011DDiscontinued by firm2026-10-12
excluded packagepackage13548-01113548-011-10DDiscontinued by firm2026-10-12

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13548-011-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13548-011-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13548-011-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13548-011-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13548-011-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13548-011-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13548-011-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13548-011-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13548-011-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13548-011-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13548-011-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13548-011-10557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13548-011-09ML - Milliliter13548-0113e465a60-f15e-4446-b5be-ff5ca08a333312012-07-24
13548-011-10ML - Milliliter13548-011512ae17a-154b-4312-900f-20c8d3d1e25112020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Salicylic acidACTIVE INGREDIENTO414PZ4LPZSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
Salicylic acidACTIVE MOIETYO414PZ4LPZSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
ammonium lactateINACTIVE INGREDIENT67M901L9NQSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
behentrimonium methosulfateINACTIVE INGREDIENT5SHP745C61SALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
cetyl alcoholINACTIVE INGREDIENT936JST6JCNSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
dimethicone 350INACTIVE INGREDIENT2Y53S6ATLUSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
edetate disodiumINACTIVE INGREDIENT7FLD91C86KSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4SALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9TSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
Polyoxyl 100 StearateINACTIVE INGREDIENTYD01N1999RSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3SALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
SODIUM LAURETH-3 SULFATEINACTIVE INGREDIENTBPV390UAP0SALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
TrolamineINACTIVE INGREDIENT9O3K93S3TKSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3
waterINACTIVE INGREDIENT059QF0KO0RSALEX (SALICYLIC ACID) CREAM SALEX (SALICYLIC ACID) LOTION SALEX (SALICYLIC ACID) SHAMPOO [CORIA LABORATORIES]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13548-011-10135480011101 BOTTLE in 1 KIT (13548-011-10) > 237 mL in 1 BOTTLE (13548-011-08) 1 bottle2004-10-010000-00-00NoNoCurrent