Home NDC 10237-787 Orajel 4X Medicated For Toothache and Gum
Product NDC 10237-787
11-digit product format 102370787
Labeler code 10237
Product ID 10237-787_45c2eac1-8aed-0f2f-e063-6294a90a0602
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium chloride, 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 BENZOCAINE; MENTHOL, UNSPECIFIED FORM; BENZALKONIUM CHLORIDE; ZINC CHLORIDE
Active strength 200; 5; 1.3; 1.5 mg/g; 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 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 4X Medicated For Toothache and Gum
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/g MENTHOL, UNSPECIFIED FORM 5 mg/g BENZALKONIUM CHLORIDE 1.3 mg/g ZINC CHLORIDE 1.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2369638 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 10237-787-25 Orajel 4X Medicated For Toothache and Gum 1 in 1 CARTON GEL 1 9 10237-787-25 Orajel 4X Medicated For Toothache and Gum 7 g in 1 TUBE GEL 7 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-787 ORAJEL 4X MEDICATED FOR TOOTHACHE AND GUM (BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE) GEL [CHURCH & DWIGHT CO., INC.] 8 Current NDC, Legacy NDC, 2 package rows 20241129_999851ac-925c-7d1f-e053-2a95a90a240b.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 10237-787-25 10237078725 1 TUBE in 1 CARTON (10237-787-25) / 7 g in 1 TUBE 1 tube 2019-11-01 0000-00-00 No No Current