Home NDC 60630-078 DenTek Instant Pain Relief Maximum Strength
Product NDC 60630-078
11-digit product format 606300078
Labeler code 60630
Product ID 60630-078_b1654017-9b63-4ab6-b461-09617e6787ad
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form LIQUID
Route DENTAL; TOPICAL
Labeler DenTek Oral Care, Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-07-31
Substance BENZOCAINE
Active strength 200 mg/mL
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 DenTek Instant Pain Relief Maximum Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/mL
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 60630-078-01 DenTek Instant Pain Relief Maximum Strength 1 in 1 CARTON LIQUID 1 1 60630-078-01 DenTek Instant Pain Relief Maximum Strength 3.5 mL in 1 VIAL, GLASS LIQUID 3.5 1
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 Sample Exclude flag Status 60630-078-01 60630007801 1 VIAL, GLASS in 1 CARTON (60630-078-01) / 3.5 mL in 1 VIAL, GLASS 2015-07-31 No No Current