Home NDC 25047-751 KOLORZ TOPICAL ANESTHETIC
Product NDC 25047-751
11-digit product format 250470751
Labeler code 25047
Product ID 25047-751_0cfa1933-ee1f-4b02-84e2-64c6e31fd29a
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route DENTAL
Labeler DMG AMERICA, LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-09-06
Substance BENZOCAINE
Active strength 200 mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 KOLORZ TOPICAL ANESTHETIC
Brand name suffix TRIPLE MINT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238910 Internal RxNorm lookup 856886 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 25047-751-01 KOLORZ TOPICAL ANESTHETICTRIPLE MINT 29.6 g in 1 BOTTLE GEL 29.6 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25047-751 KOLORZ TOPICAL ANESTHETIC TRIPLE MINT (BENZOCAINE) GEL KOLORZ TOPICAL ANESTHETIC CHERRY BURST (BENZOCAINE) GEL KOLORZ TOPICAL ANESTHETIC COTTON CANDY (BENZOCAINE) GEL KOLORZ TOPICAL ANESTHETIC BLUE RASBERRY (BENZOCAINE) GEL KOLORZ TOPICAL ANESTHETIC PINA COLADA (BENZOCAINE) GEL [DMG AMERICA, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20241124_0f90b227-f938-4e1a-a79e-1967b1a0477e.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 9 of 40 · 786 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 25047-751-01 25047075101 29.6 g in 1 BOTTLE (25047-751-01) 29.6 g 2019-09-06 0000-00-00 No No Current