FDA.reportPublic FDA data

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

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
IngredientStrength
HYDROGEN PEROXIDE15 mg/mL
MENTHOL, UNSPECIFIED FORM1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBBX060AN9V, L7T10EIP3A
Rxcui2584344

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10237-760-162021-11-04C16284748780-19d75b9d0-0d7b-f424-e053-dadaa90a57ceOrajel Antiseptic Rinse for All Mouth Sores
10237-760-162020-01-31C16284748780-19d75b9d0-0d7b-f424-e053-dadaa90a57ceOrajel Antiseptic Rinse for All Mouth Sores

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-760-16Orajel Antiseptic Rinse For All Mouth Sores473.2 mL in 1 BOTTLELIQUID473.25
10237-760-48Orajel Antiseptic Rinse For All Mouth Sores3 in 1 PACKAGELIQUID35
10237-760-48Orajel Antiseptic Rinse For All Mouth Sores473.2 mL in 1 BOTTLELIQUID473.25

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROGEN PEROXIDEACTIVE INGREDIENTBBX060AN9VORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.]1
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9VORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3AORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.]1
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.]1
POLOXAMER 338INACTIVE INGREDIENTF75JV2T505ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE 1.5%, MENTHOL 0.1%) LIQUID [CHURCH & DWIGHT CO., INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RORAJEL 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
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-760ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES (HYDROGEN PEROXIDE AND MENTHOL) LIQUID [CHURCH & DWIGHT CO., INC.]4Current NDC, Legacy NDC, 3 package rows20241128_06188d36-0d60-6ae6-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2584344hydrogen peroxide 1.5 % / menthol 0.1 % Mucous Membrane Topical SolutionPSN06188d36-0d60-6ae6-e054-00144ff8d46c5
2584344hydrogen peroxide 15 MG/ML / menthol 1 MG/ML Mucous Membrane Topical SolutionSCD06188d36-0d60-6ae6-e054-00144ff8d46c5
2584344hydrogen peroxide 1.5 % / menthol 0.1 % Mucous Membrane Topical SolutionSY06188d36-0d60-6ae6-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-760-1610237076016473.2 mL in 1 BOTTLE (10237-760-16) 473.2 ml2014-11-010000-00-00NoNoCurrent
10237-760-48102370760483 BOTTLE in 1 PACKAGE (10237-760-48) / 473.2 mL in 1 BOTTLE3 bottle2021-09-010000-00-00NoNoCurrent