Home NDC 10237-790 Orajel 3X Medicated For Toothache and Gum
Product NDC 10237-790
11-digit product format 102370790
Labeler code 10237
Product ID 10237-790_45c2eb22-063f-1dd9-e063-6394a90aae42
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine, Menthol, Zinc chloride
Dosage form GEL
Route TOPICAL
Labeler Church & Dwight Co., Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-11-01
Substance MENTHOL; BENZOCAINE; ZINC CHLORIDE
Active strength 2.6; 200; 1.5 mg/g; mg/g; mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 10237-790 10237-790-12 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 10237-790 10237-790-12 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 10237-790 10237-790-12 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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 3X Medicated For Toothache and Gum
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 2.6 mg/g BENZOCAINE 200 mg/g ZINC CHLORIDE 1.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup U3RSY48JW5 Internal UNII lookup 86Q357L16B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2362013 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 10237-790-12 Orajel 3X Medicated For Toothache and Gum 3.5 g in 1 TUBE GEL 3.5 11 10237-790-12 Orajel 3X Medicated For Toothache and Gum 1 in 1 CARTON GEL 1 11 10237-790-25 Orajel 3X Medicated For Toothache and Gum 1 in 1 CARTON GEL 1 11 10237-790-25 Orajel 3X Medicated For Toothache and Gum 7 g in 1 TUBE GEL 7 11 10237-790-42 Orajel 3X Medicated For Toothache and Gum 1 in 1 CARTON GEL 1 11 10237-790-42 Orajel 3X Medicated For Toothache and Gum 11.9 g in 1 TUBE GEL 11.9 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-790 ORAJEL 3X MEDICATED FOR TOOTHACHE AND GUM (BENZOCAINE, MENTHOL, ZINC CHLORIDE) GEL [CHURCH & DWIGHT CO., INC.] 10 Current NDC, Legacy NDC, 6 package rows 20241129_99a2b061-0875-59a4-e053-2995a90ab373.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 9 of 41 · 818 matching rows.
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 10237-790-12 10237079012 1 TUBE in 1 CARTON (10237-790-12) / 3.5 g in 1 TUBE 1 tube 2019-11-01 0000-00-00 No No Current 10237-790-25 10237079025 1 TUBE in 1 CARTON (10237-790-25) / 7 g in 1 TUBE 1 tube 2019-11-01 0000-00-00 No No Current 10237-790-42 10237079042 1 TUBE in 1 CARTON (10237-790-42) / 11.9 g in 1 TUBE 1 tube 2019-11-01 0000-00-00 No No Current