Home NDC 10237-764-08 Orajel Toothache Rinse
Product NDC 10237-764
Requested package NDC 10237-764-08
11-digit product format 102370764
Labeler code 10237
Product ID 10237-764_27e7c3b6-5f9a-a7f3-e063-6394a90a02a7
Type HUMAN OTC DRUG
Nonproprietary name Benzyl Alcohol, Zinc Chloride
Dosage form LIQUID
Route TOPICAL
Labeler Church & Dwight Co., Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-12-01
Substance BENZYL ALCOHOL; ZINC CHLORIDE
Active strength 2.7; 1.5 mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Pediculicide [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 Toothache Rinse
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZYL ALCOHOL 2.7 mg/mL ZINC CHLORIDE 1.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LKG8494WBH 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 1865199 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 10237-764-08 Orajel Toothache Rinse 236.6 mL in 1 BOTTLE LIQUID 236.6 8 10237-764-16 Orajel Toothache Rinse 473.2 mL in 1 BOTTLE LIQUID 473.2 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-764 ORAJEL TOOTHACHE RINSE (BENZYL ALCOHOL, ZINC CHLORIDE) LIQUID [CHURCH & DWIGHT CO., INC.] 8 Current NDC, Legacy NDC, 2 package rows 20241128_41709710-5392-3119-e054-00144ff88e88.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 27 of 40 · 786 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 10237-764-08 10237076408 236.6 mL in 1 BOTTLE (10237-764-08) 236.6 ml 2016-12-01 0000-00-00 No No Current