Home NDC 10237-760 Orajel Antiseptic Rinse For All Mouth Sores
Product NDC 10237-760
11-digit product format 102370760
Labeler code 10237
Product ID 10237-760_45c2ec2f-1ee1-84f8-e063-6294a90ae393
Type HUMAN OTC DRUG
Nonproprietary name Hydrogen Peroxide and Menthol
Dosage form LIQUID
Route ORAL
Labeler Church & Dwight Co., Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-11-01
Substance HYDROGEN PEROXIDE; MENTHOL, UNSPECIFIED FORM
Active strength 15; 1 mg/mL; mg/mL
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 10237-760-16 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 10237-760-16 9bebd1f3094a…5416666fcb17…
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 Antiseptic Rinse For All Mouth Sores
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROGEN PEROXIDE 15 mg/mL MENTHOL, UNSPECIFIED FORM 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BBX060AN9V Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2584344 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10237-760-16 Orajel Antiseptic Rinse For All Mouth Sores 473.2 mL in 1 BOTTLE LIQUID 473.2 5 10237-760-48 Orajel Antiseptic Rinse For All Mouth Sores 3 in 1 PACKAGE LIQUID 3 5 10237-760-48 Orajel Antiseptic Rinse For All Mouth Sores 473.2 mL in 1 BOTTLE LIQUID 473.2 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROGEN PEROXIDE ACTIVE INGREDIENT BBX060AN9V ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.] 1 MENTHOL ACTIVE INGREDIENT L7T10EIP3A ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.] 1 HYDROGEN PEROXIDE ACTIVE MOIETY BBX060AN9V ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.] 1 METHYL SALICYLATE INACTIVE INGREDIENT LAV5U5022Y ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.] 1 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.] 1 POLOXAMER 338 INACTIVE INGREDIENT F75JV2T505 ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-760 ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE AND MENTHOL) LIQUID [CHURCH & DWIGHT CO., INC.] 4 Current NDC, Legacy NDC, 3 package rows 20241128_06188d36-0d60-6ae6-e054-00144ff8d46c.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 41 · 818 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City e554b5b2-cf91-464a-a930-3e1087f12c8d 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 98da331c-76c2-49fe-b687-6bfba4ae2e75 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City d2195efa-597d-4ba9-a9b0-8df0d8f49311 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City fba82d55-94db-4432-b532-603fe57202be 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 9ed0fe31-e5f2-4d6d-8686-1286c6659847 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City d5f42c30-343c-4e1d-950c-89bbd361fd27 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 7dce407f-bbe4-4a27-97ff-be33fd447461 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC cb7f28f3-a908-47a9-e053-2995a90a6cbd 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 921bdb76-f6d3-4e0a-a0ac-277dcc4e8d28 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. a80cfd29-8314-4639-a811-afd5fdb630b0 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 69271b7a-18c0-4445-8164-cb1620fb5475 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 40bd7406-7ee6-47fe-8481-0a4c8cefce65 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 43194fe1-87a1-4ffa-ad73-a1dcec91fd63 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. b0b3ab27-704a-44b8-8473-d21ac3359ba1 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 39f64f10-f442-45a9-a060-9f99e78c678d 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. ed5a294a-fc03-43dd-825d-23a232060900 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. be558e5b-cf35-4035-a69c-8d66deeac6b2 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. a2591a96-ed66-45b1-abf6-6b26d0bb4f44 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. efe92e48-5086-4b61-a298-0d8ceefe100e 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. 1d6a1182-ab63-460a-ab91-8d4c2ae5d01e 2025-01-09 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 10237-760-16 10237076016 473.2 mL in 1 BOTTLE (10237-760-16) 473.2 ml 2014-11-01 0000-00-00 No No Current 10237-760-48 10237076048 3 BOTTLE in 1 PACKAGE (10237-760-48) / 473.2 mL in 1 BOTTLE 3 bottle 2021-09-01 0000-00-00 No No Current