Home NDC 42961-810 Dental Relief
Product NDC 42961-810
11-digit product format 429610810
Labeler code 42961
Product ID 42961-810_8ac8fc4b-8b2d-408d-b9ab-dcacda68471d
Type HUMAN OTC DRUG
Nonproprietary name benzocaine
Dosage form LIQUID
Route TOPICAL
Labeler Cintas Corporation
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-04-08
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 Dental Relief
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 · 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42961-810-02 Dental Relief 0.5 g in 1 PACKET LIQUID 0.5 6 42961-810-03 Dental Relief 10 in 1 BAG LIQUID 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42961-810 DENTAL RELIEF (BENZOCAINE) LIQUID [CINTAS CORPORATION] 5 Current NDC, Legacy NDC, 2 package rows 20241226_0f40f775-797e-43cf-88c9-00eea666494f.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 40 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Iolite BENZOCAINE Dharma Research, Inc. e4b2d22b-00b3-45a6-9b7d-8ee719587059 2023-10-09 Warnings Exact identifier application number: M022 Iolite BENZOCAINE Dharma Research, Inc. a0e284f6-292f-4231-8596-f7cee4e0a12f 2023-10-09 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC fe92637a-c88a-f9dd-e053-6294a90a7fa3 2023-07-01 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC c979e958-2042-471a-bf03-e84e68620106 2023-06-20 Warnings Exact identifier application number: M022 Orajel Gum Pain 3X Medicated BENZOCAINE, MENTHOL, ZINC CHLORIDE Church & Dwight Co., Inc. 9a1632ad-2b47-5653-e053-2995a90ae0d9 2023-01-20 Warnings Exact identifier application number: M022 KOLORZ TOPICAL ANESTHETIC TRIPLE MINT BENZOCAINE DMG AMERICA, LLC 0f90b227-f938-4e1a-a79e-1967b1a0477e 2021-10-01 Warnings Exact identifier application number: M022
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 42961-810-02 42961081002 0.5 g in 1 PACKET 0.5 g Historical 42961-810-03 42961081003 10 PACKET in 1 BAG (42961-810-03) / .5 g in 1 PACKET (42961-810-02) 10 packet 2021-04-08 0000-00-00 No No Current 42961-810-04 42961081004 500 PACKET in 1 BOX (42961-810-04) > .5 g in 1 PACKET (42961-810-02) 500 packet 2021-04-08 0000-00-00 No No Current