Home NDC 10237-889 Orajel 4X Medicated Toothache and Gum PM Cream
Product NDC 10237-889
11-digit product format 102370889
Labeler code 10237
Product ID 10237-889_5a1cdaf4-3389-280c-e063-6294a90ac70f
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride
Dosage form CREAM
Route TOPICAL
Labeler Church & Dwight Co., Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-31
Substance BENZOCAINE; BENZALKONIUM CHLORIDE; ZINC CHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength 200; .2; 1.5; 2.6 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 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 4X Medicated Toothache and Gum PM Cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/g BENZALKONIUM CHLORIDE .2 mg/g ZINC CHLORIDE 1.5 mg/g MENTHOL, UNSPECIFIED FORM 2.6 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 2751338 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 17 of 41 · 818 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Oral Pain Relief BENZOCAINE AND BENZALKONIUM CHLORIDE Universal Distribution Center LLC 18520f9b-4d35-1e9c-e063-6294a90aaa39 2025-10-30 Warnings Exact identifier application number: M022 Iodent Oral Analgesic BENZOCAINE United Exchange Corp. 63902125-f8dc-0ada-e053-2991aa0a7ce5 2025-10-30 Warnings Exact identifier application number: M022 Ear Wax Removal Aid Drops CARBAMIDE PEROXIDE BETTER LIVING BRANDS, LLC 3bded237-4d2c-4b38-bedc-267fdc374194 2025-10-29 Warnings Exact identifier application number: M022 WALMART SALINE SALINE NASAL (SODIUM CHLORIDE) WALMART STORES INC 06906744-49a5-4bab-8539-af2d235df9e8 2025-10-28 Warnings Exact identifier application number: M022 Saline NASAL PUBLIX SUPER MARKETS, INC 19841567-9511-43d6-ba4e-d1e1bd3481a4 2025-10-28 Warnings Exact identifier application number: M022 PUBLIX Sore Throat Fast Relief Oral Anesthetic PHENOL PUBLIX SUPER MARKETS, INC 89291f12-bbc3-4472-8ad3-a34485af72c9 2025-10-28 Warnings Exact identifier application number: M022 PUBLIX Sore Throat Menthol Flavor PHENOL PUBLIX SUPER MARKETS, INC 9296c49e-557c-43ed-9527-fcba5093a8dc 2025-10-28 Warnings Exact identifier application number: M022 WinCo Foods Maximum Strength Oral Analgesic BENZOCAINE WinCo Foods, LLC c22a7726-8c3f-41bf-b852-8456b2be6f93 2025-10-28 Warnings Exact identifier application number: M022 Rugby Cherry Flavor PHENOL RUGBY LABORATORIES 3d668c78-8130-45d4-bcb7-dddcb2fbe7a3 2025-10-25 Warnings Exact identifier application number: M022 LolliCaine Bubble Gum BENZOCAINE Centrix, Inc. 56ae3a84-6bca-4906-a03d-9d755e1fba3b 2025-10-24 Warnings Exact identifier application number: M022 Meijer Sore Throat PHENOL MEIJER DISTRIBUTION INC. 360f9756-1cd7-41b2-8ee2-9d1bb7234cf1 2025-10-24 Warnings Exact identifier application number: M022 MEIJER Saline NASAL MEIJER a5c6d800-078a-4b66-9d4c-cf3c53f5c138 2025-10-24 Warnings Exact identifier application number: M022 meijer Maximum Strength Sore Throat Fast Relief PHENOL AND GLYCERIN MEIJER DISTRIBUTION INC f1f17aab-7ea7-4dac-a854-48b4b560ec4f 2025-10-24 Warnings Exact identifier application number: M022 Diabetic Tussin Sore Throat Cherry PHENOL MEDTECH PRODUCTS INC ab351229-5771-4c6c-92a8-721cc41c002f 2025-10-23 Warnings Exact identifier application number: M022 Chloraseptic Total Sore Throat and Cough, Sugar Free MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE Prestige Brands Holdings, Inc. 34e4234c-ed61-4795-99fe-d281cdb0af88 2025-10-23 Warnings Exact identifier application number: M022 Chloraseptic Total Sore Throat and Cough MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE Prestige Brands Holdings, Inc. 6b1a50d0-be54-4fcb-b5e2-b47abf3555c0 2025-10-23 Warnings Exact identifier application number: M022 Chloraseptic Childrens Sore Throat Cherry PHENOL Prestige Brands Holdings, Inc. 38ff6922-1abe-4fa9-a74e-ede604f707b5 2025-10-23 Warnings Exact identifier application number: M022 Boka Sensitive POTASSIUM NITRATE Karaka LLC 40be9fab-53db-c67a-e063-6394a90a48cb 2025-10-23 Warnings Exact identifier application number: M022 Canker Care Plus MENTHOL, UNSPECIFIED FORM Quantum, Inc. 1ec960db-52d5-4d99-a7f7-a2e538d28724 2025-10-20 Warnings Exact identifier application number: M022 meijer Sensitive EXTRA WHITENING POTASSIUM NITRATE, SODIUM FLUORIDE Meijer, Inc. bbcffb88-0bd4-4883-bb83-0b7a1428ad12 2025-10-20 Warnings Exact identifier application number: M022
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10237-889-25 10237088925 1 TUBE in 1 CARTON (10237-889-25) / 7 g in 1 TUBE 1 tube 2026-08-31 No No Current