Home NDC 10237-796 Orajel Medicated for Toothache and Gum, Liquid
Product NDC 10237-796
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 34 of 41 · 818 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 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