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

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10237-760-16e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage10237-760-169bebd1f3094a…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
IngredientStrength
HYDROGEN PEROXIDE15 mg/mL
MENTHOL, UNSPECIFIED FORM1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BBX060AN9VInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2584344Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06188d36-0d60-6ae6-e054-00144ff8d46cAvailable on FDA.report

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

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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Gum Therapy Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCed6889b6-58db-41cf-e053-2a95a90a7de22024-11-11WarningsExact identifier
application number: M022
Listerine FreshBurst AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC62b5c3ee-01cc-4c4e-9f28-e7dafa7372d82024-11-11WarningsExact identifier
application number: M022
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLCdd3729c2-fd05-4db0-a542-487bb0f9001f2024-11-11WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC9e97e4f8-80c2-44e0-862c-0dfca392a4362024-11-11WarningsExact identifier
application number: M022
Orajel 2X Medicated GelORAL PAIN RELIEVERChurch & Dwight Co., Inc.262be295-4eaf-3136-e063-6294a90a7dcc2024-11-05WarningsExact identifier
application number: M022
BIOTENE Fresh Mint OriginalSODIUM FLUORIDEHaleon US Holdings LLC1101c17f-c848-4cd5-a7cd-679b59dbe1bf2024-11-05WarningsExact identifier
application number: M022
bioteneSODIUM MONOFLUOROPHOSPHATEHaleon US Holdings LLCa47a6502-efb2-4072-9562-cbe293531c2b2024-11-04WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser CherrySODIUM PERBORATE MONOHYDRATEVintage Brands Limiteda0e145c8-6b08-40be-ae4f-5678c4a78b1e2024-10-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33b-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33a-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043a3cb4-f560-0ffd-e063-6394a90a2ff62024-10-29WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser MintSODIUM PERBORATE MONOHYDRATEVintage Brands Limitedbe57ca56-834f-4170-a407-f193484d8b0a2024-10-29WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean MintSODIUM FLUORIDEHaleon US Holdings LLC817c0dad-d109-428e-adb5-3354604acc942024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC1f3d68f6-afd6-42e7-b3e5-210228c8e7de2024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals LLC0dd15227-6603-42ac-9a5f-f2dc49e0382a2024-10-28Warnings, Adverse reactionsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0605d5d6-82bd-415e-b5cb-e273f934a4a72024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLCf70fa3fc-cd65-4a80-9efd-129e98fd39982024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief MentholPHENOLChain Drug Consortiumaf661ef0-cdc3-4146-8ae5-59795aa496502024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief Cherry FlavorPHENOLChain Drug Consortiuma9cf9829-4b70-44fa-9719-240b65c067242024-10-28WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEPHARMACY VALUE ALLIANCE, LLC85ae80c1-2bc2-4c90-9559-63510d03e7392024-10-28WarningsExact identifier
application number: M022

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