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 28 of 41 · 818 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. e1db79a4-4a24-4c3f-9ee9-2af3f876ac96 2025-01-09 Warnings Exact identifier application number: M022 iSmile Topical Anesthetic BENZOCAINE iSmile Dental Products, Inc. d3b6669e-479f-4bc1-b533-5e9a0cc65213 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. e42a22ef-1035-4dd0-94b0-43625542d584 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. 3dca05de-cf63-4ca0-88be-473ea637e6b4 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. d6149dfd-f2a5-4bbd-913c-6a95efe5ffd2 2025-01-09 Warnings Exact identifier application number: M022 Tiger Supply Inc Topical Anesthetic BENZOCAINE Tiger Supply Inc. c6eda1de-4490-4a28-8a31-cbf3e102e74e 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc 4261cd90-5087-44a3-bef9-72d33dbf0dfd 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc e70240a8-fa9d-4005-a3a0-5cca6188bf61 2025-01-09 Warnings Exact identifier application number: M022 Comfortcaine Topical Anesthetic BENZOCAINE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc fda3d254-e103-4be9-9086-51ad022b2b3f 2025-01-09 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental c161da79-9ea5-4c7f-890c-4315129fe5bf 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental f7862ee9-117a-493d-83ee-5aef588a86de 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental 011c6a04-a489-41a5-ad2f-8ec281e07933 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental 45422b0f-f1ac-4bec-851a-c1394bc52fcc 2025-01-08 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043c336f-60e3-dc23-e063-6294a90a4b13 2025-01-08 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC e67b8def-c728-4952-9b35-874643cbe0f1 2025-01-08 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC e628bd9f-99e5-4c71-ba8a-caa6c337de54 2025-01-08 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC fef1f48c-e89d-4b75-9ba0-b1b068daf582 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental b18c2bfc-638e-40a7-8ecb-60303aa3f519 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental 64b9ebe6-afbe-4db2-b4bf-14ff5d007ea0 2025-01-08 Warnings Exact identifier application number: M022 Primo Topical Anesthetic BENZOCAINE Tri State Dental f5d37a12-9db1-4f2c-9dd1-72a8361e0e57 2025-01-08 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