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 4 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GingiCaine Gel, Pina ColadaGINGICAINE GEL, PINA COLADA FLAVORGingi-Pak a Division of the Belport6284e1fe-be33-69bf-e053-2991aa0a90ab2026-06-29WarningsExact identifier
application number: M022
GingiCaine Gel, Chocolate MintGINGICAINE GEL, CHOCOLATE MINT FLAVORGingi-Pak a Division of the Belport6285c4f2-c139-49a9-e053-2991aa0a2b032026-06-29WarningsExact identifier
application number: M022
UltraCare Anesthetic GelBENZOCAINEThe Bellport Company, Inc. dba Gingi-Pakf5dd8fa8-0b6a-5a30-e053-2995a90ad1942026-06-26WarningsExact identifier
application number: M022
GingiCaine GelGINGICAINE GEL BANANA FLAVORGingi-Pak a Division of the Belport62857d06-a829-4efa-e053-2991aa0a6d152026-06-25WarningsExact identifier
application number: M022
GingiCaine Gel, Cotton Candy FlavorGINGICAINE GEL, COTTON CANDY FLAVORGingi-Pak a Division of the Belport628515a5-175f-ac2c-e053-2991aa0a19ce2026-06-25WarningsExact identifier
application number: M022
Perox-A-Mint SolutionHYDROGEN PEROXIDESage Products, LLC50823ff5-ad08-4449-bc4a-9a8ae25ec0d52026-06-24WarningsExact identifier
application number: M022
Antiseptic Oral RinseCETYLPYRIDINIUM CHLORIDESage Products LLCefff8bae-154d-46bc-8dd4-7168004256632026-06-24Exact identifier
application number: M022
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brands8c6ac499-9bd2-4ea5-9f26-df7947bff4a62026-06-22WarningsExact identifier
application number: M022
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brandsdcc37403-0192-4658-bb7a-059273ce00472026-06-22WarningsExact identifier
application number: M022
ToothachePOLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDEGuchutang Biotechnology (Longyan) Co., Ltd54ad2ceb-272f-e5ba-e063-6394a90aec5f2026-06-20WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEDelon Laboratories (1990) Ltdd4aa09bf-8207-47dd-bc42-01e660da94382026-06-16WarningsExact identifier
application number: M022
TideFresh MOUTH SORE AND TOOTHACHEBENZOCAINE 20% MOUTH SORE AND TOOTHACHEWenzhou Yuyuan Pharmaceutical Co., Ltd.541e1814-c00e-efdf-e063-6394a90a41a12026-06-13WarningsExact identifier
application number: M022
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
application number: M022
OrazenSODIUM MONOFLUOROPHOSPHATEOrazen Incfa5b6bd8-443f-79e7-e053-6394a90a55132026-06-03WarningsExact identifier
application number: M022
Fishermans Friend Mixed BerryMENTHOLLofthouse of Fleetwood53391c4d-ee2d-ade3-e063-6394a90ac77d2026-06-01WarningsExact identifier
application number: M022
Orajel Medicated for Toothache and Gum, LiquidBENZOCAINE AND MENTHOLChurch & Dwight Co., Inc.ac3d605d-241d-1a6f-e053-2a95a90ae3912026-06-01WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFBENZOCAINE AND MENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6140d487-d87c-4954-9247-83492bcc57382026-05-27WarningsExact identifier
application number: M022
Dolodent Maximum StrengthBENZOCAINEPharmadel LLC351ecc2b-cc1a-2bbf-e063-6394a90a5c142026-05-26WarningsExact identifier
application number: M022
MOUTH ULCERPANTHENOLGuangzhou Shengli Shidai Cosmetics Co., Ltd.5264f81c-bffe-4f6d-e063-6394a90ae3bf2026-05-22WarningsExact identifier
application number: M022
Sensitivity Relief Fluoride FreePOTASSIUM NITRATEHealth and Natural Beauty USA Corpc23b2a83-ebc3-4bcf-a216-7693944dcfa02026-05-22WarningsExact 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