FDA.reportPublic FDA data

TKTX

Manufacturer
COMMERCE OPERATIONS LLC
Effective date
2025-03-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:57:46

Label at a glance#

ProductTKTX
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingrediantsActive ingrediants

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive Ingredients

WARNINGS SECTION

warningwarning

OTC - WHEN USING SECTION

when usingwhen using

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childrenkeep out of reach of children

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

INDICATIONS & USAGE SECTION

Indication and usageIndication and usage

OTC - PURPOSE SECTION

purposepurpose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DisplayDisplay

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2548833salicylic acid 5 % Topical CreamPSN4
2548833salicylic acid 50 MG/ML Topical CreamSCD4
2548833salicylic acid 5 % Topical CreamSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85310-302-01TKTX1 g in 1 TUBECREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85310-302TKTX CREAM [COMMERCE OPERATIONS LLC]4Current NDC, 1 package rows20250327_2f867e2b-df7d-c34a-e063-6294a90a1724.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85310-30285310-302-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN E POLYETHYLENE GLYCOL SUCCINATEO03S90U1F2IACT
BENZYL ALCOHOLLKG8494WBHIACT
CREAM463JZS0XJ3IACT
ALOEV5VD430YW9IACT
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TKTXTKTXCOMMERCE OPERATIONS LLC2f867e2b-df7d-c34a-e063-6294a90a17242025-03-25WarningsExact identifier
ndc (package): 85310-302-01
ndc (product): 85310-302
ndc11 (package): 85310030201
spl id: 31300b5b-7fb3-d5bb-e063-6394a90a041d
spl set id: 2f867e2b-df7d-c34a-e063-6294a90a1724

Reported adverse events (FAERS/openFDA)#

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