Home NDC 10237-796-45 Orajel Medicated for Toothache and Gum, Liquid
Product NDC 10237-796
Requested package NDC 10237-796-45
11-digit product format 102370796
Labeler code 10237
Product ID 10237-796_557be35d-65ca-291a-e063-6294a90aac6e
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine and Menthol
Dosage form LIQUID
Route TOPICAL
Labeler Church & Dwight Co., Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-08-07
Substance BENZOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength 200; 1 mg/mL; 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 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 Orajel Medicated for Toothache and Gum, Liquid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/mL MENTHOL, UNSPECIFIED FORM 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2110600 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10237-796-45 Orajel Medicated for Toothache and Gum, Liquid 13.3 mL in 1 BOTTLE, GLASS LIQUID 13.3 5 10237-796-45 Orajel Medicated for Toothache and Gum, Liquid 1 in 1 CARTON LIQUID 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-796 ORAJEL MEDICATED FOR TOOTHACHE AND GUM, LIQUID (BENZOCAINE AND MENTHOL) LIQUID [CHURCH & DWIGHT CO., INC.] 4 Current NDC, Legacy NDC, 2 package rows 20241129_ac3d605d-241d-1a6f-e053-2a95a90ae391.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 Marketing start Marketing end Sample Exclude flag Status 10237-796-45 10237079645 1 BOTTLE, GLASS in 1 CARTON (10237-796-45) / 13.3 mL in 1 BOTTLE, GLASS 2020-08-07 0000-00-00 No No Current