Home NDC 10733-166 Topicale
Product NDC 10733-166
11-digit product format 107330166
Labeler code 10733
Product ID 10733-166_28dd05fd-da61-a52d-e063-6394a90afe83
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route ORAL
Labeler Medical Products Laboratories, Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-03-05
Substance BENZOCAINE
Active strength 180 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 Topicale
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 180 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 1042838 Internal RxNorm lookup 1049213 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10733-166-35 Topicale 35 g in 1 CARTON GEL 35 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10733-166 TOPICALE (BENZOCAINE) GEL [MEDICAL PRODUCTS LABORATORIES, INC.] 4 Current NDC, 1 package rows 20241213_826eaef8-4457-3dc2-e053-2991aa0a528b.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 27 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 Sample Exclude flag Status 10733-166-35 10733016635 35 g in 1 CARTON (10733-166-35) 35 g 2019-03-05 No No Current