FDA.reportPublic FDA data

Orajel Antiseptic Alcohol-Free Mouth Sore Rinse

Product NDC
10237-784
11-digit product format
102370784
Labeler code
10237
Product ID
10237-784_27ea6bc8-f26b-d947-e063-6394a90ae2f5
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen peroxide, Menthol
Dosage form
LIQUID
Route
ORAL
Labeler
Church & Dwight Co., Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-01
Substance
MENTHOL, UNSPECIFIED FORM; HYDROGEN PEROXIDE
Active strength
1; 15 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 Alcohol-Free Mouth Sore Rinse
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM1 mg/mL
HYDROGEN PEROXIDE15 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
BBX060AN9VInternal 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
99d47d6a-fa2e-d5ee-e053-2995a90aa11dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-784-16Orajel Antiseptic Alcohol-Free Mouth Sore Rinse473.2 mL in 1 BOTTLELIQUID473.26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-784ORAJEL ANTISEPTIC ALCOHOL-FREE MOUTH SORE RINSE (HYDROGEN PEROXIDE, MENTHOL) LIQUID [CHURCH & DWIGHT CO., INC.]6Current NDC, Legacy NDC, 1 package rows20241129_99d47d6a-fa2e-d5ee-e053-2995a90aa11d.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 SolutionPSN99d47d6a-fa2e-d5ee-e053-2995a90aa11d6
2584344hydrogen peroxide 15 MG/ML / menthol 1 MG/ML Mucous Membrane Topical SolutionSCD99d47d6a-fa2e-d5ee-e053-2995a90aa11d6
2584344hydrogen peroxide 1.5 % / menthol 0.1 % Mucous Membrane Topical SolutionSY99d47d6a-fa2e-d5ee-e053-2995a90aa11d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-784-1610237078416473.2 mL in 1 BOTTLE (10237-784-16) 473.2 ml2019-11-010000-00-00NoNoCurrent