Home NDC 36800-443 Topcare
Product NDC 36800-443
11-digit product format 368000443
Labeler code 36800
Product ID 36800-443_5d30e185-1cc3-2777-e063-6394a90a7577
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form LIQUID
Route ORAL
Labeler Topco Associates LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-10-01
Substance BENZOCAINE
Active strength 20 g/100g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 Topcare
Brand name suffix Maximum Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 20 g/100g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308657 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 36800-443-58 TopcareMaximum Strength 14.17 g in 1 BOTTLE, WITH APPLICATOR LIQUID 14.17 14 36800-443-58 TopcareMaximum Strength 1 in 1 BLISTER PACK LIQUID 1 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-443 TOPCARE MAXIMUM STRENGTH (BENZOCAINE) LIQUID [TOPCO ASSOCIATES LLC] 13 Current NDC, Legacy NDC, 2 package rows 20250119_6586fcda-b232-46b4-8461-c0042a4127c6.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 32 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 36800-443-48 36800044348 1 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK (36800-443-48) > 14.17 g in 1 BOTTLE, WITH APPLICATOR 2014-10-01 0000-00-00 No No Current 36800-443-58 36800044358 1 BOTTLE, WITH APPLICATOR in 1 BLISTER PACK (36800-443-58) / 14.17 g in 1 BOTTLE, WITH APPLICATOR 2014-10-01 No No Current