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 2 of 41 · 818 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ludens Watermelon Throat Drops PECTIN Prestige Brands Holdings, Inc. adfb248a-96bb-4742-9df6-c47edccdd671 2026-08-20 Warnings Exact identifier application number: M022 Antiseptic EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL WALMART INC. (see also Equate) 584b38ce-d1ef-4ecc-a887-7c96e7f9669f 2026-08-20 Warnings Exact identifier application number: M022 Antiseptic EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL Walgreens fb93c7f6-e025-4cf2-9997-acfe9a0debdd 2026-08-19 Warnings Exact identifier application number: M022 CVS Saline NASAL CVS PHARMACY f02c41b0-c78e-41cd-aa4a-2756bbe92087 2026-08-19 Warnings Exact identifier application number: M022 Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL Kenvue Brands LLC 5965eb2a-1261-5258-e063-6294a90a7c2d 2026-08-19 Warnings Exact identifier application number: M022 Ludens Honey Licorice Throat Drops MENTHOL Prestige Brands Holdings, Inc. 5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac 2026-08-19 Warnings Exact identifier application number: M022 Ludens Dual Relief PECTIN AND MENTHOL Prestige Brands Holdings, Inc. d0213cb3-ec8e-40cc-82c9-694032f0490f 2026-08-19 Warnings Exact identifier application number: M022 CVS Health Sore Throat Fast Relief Oral Anesthetic PHENOL CVS Pharmacy,Inc. 4fb880db-2185-41ef-a5f9-8983a28d2c5b 2026-08-17 Warnings Exact identifier application number: M022 CVS Sore Throat Cherry PHENOL CVS Pharmacy,Inc. 887c68e0-ff44-4bad-b360-56fb99ed9c45 2026-08-17 Warnings Exact identifier application number: M022 CVS Sore Throat Menthol Flavor PHENOL CVS PHARMACY,INC. 665be058-b965-4b78-80b0-dd8524180932 2026-08-17 Warnings Exact identifier application number: M022 Hydrogen Peroxide 3 Percent HYDROGEN PEROXIDE Harris Teeter, LLC 7e5f175d-f0d6-4665-ac14-1873d6b99c80 2026-08-12 Warnings Exact identifier application number: M022 Gingicaine Gel Variety Pak GINGICAINE GEL VARIETY PAK Gingi-Pak a Division of the Belport 62ed4ff3-18f6-5c67-e053-2991aa0a7792 2026-08-11 Warnings Exact identifier application number: M022 Hydrogen Peroxide 3 Percent ReadyInCase HYDROGEN PEROXIDE P & L Development, LLC b0866db5-3b0d-4478-9b3b-1f077d2f5393 2026-08-06 Warnings Exact identifier application number: M022 Ollie Fresh Mint SODIUM FLUORIDE, POTASSIUM NITRATE Brio Product Group LLC. ebeec44f-3c22-43f2-9256-6ece6025c105 2026-08-06 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE Top Quality Manufacturing, Inc. 5868c5a1-273f-f023-e063-6394a90ac9d8 2026-08-06 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE Top Quality Manufacturing, Inc. 58690bb5-9604-26a4-e063-6394a90afdbe 2026-08-06 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE Top Quality Manufacturing, Inc. 586918cf-7b13-5999-e063-6294a90a88a9 2026-08-06 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE Top Quality Manufacturing, Inc. 586924a0-322d-5dc3-e063-6294a90a1556 2026-08-06 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE Top Quality Manufacturing, Inc. 58692e90-de74-52d3-e063-6394a90a9702 2026-08-06 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE Top Quality Manufacturing, Inc. 586937ae-46af-7066-e063-6294a90ae53e 2026-08-06 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