Home NDC 85310-302 TKTX
Product NDC 85310-302
11-digit product format 853100302
Labeler code 85310
Product ID 85310-302_31300b5b-7fb3-d5bb-e063-6394a90a041d
Type HUMAN OTC DRUG
Nonproprietary name TKTX
Dosage form CREAM
Route TOPICAL
Labeler COMMERCE OPERATIONS LLC
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-04
Marketing end 2027-12-31
Substance SALICYLIC ACID
Active strength 5 g/100g
NDC exclude flag No
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TKTX Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID 5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O414PZ4LPZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2548833 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85310-302-01 TKTX 1 g in 1 TUBE CREAM 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85310-302 TKTX CREAM [COMMERCE OPERATIONS LLC] 4 Current NDC, 1 package rows 20250327_2f867e2b-df7d-c34a-e063-6294a90a1724.zip
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 7 of 55 · 1,088 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 85310-302-01 85310030201 1 g in 1 TUBE (85310-302-01) 1 g 2025-03-04 2027-12-31 No No Historical