FDA.reportPublic FDA data

Orajel 2x Gum Pain

Product NDC
10237-799
11-digit product format
102370799
Labeler code
10237
Product ID
10237-799_27eb6e9e-5cd7-d08a-e063-6394a90ad5b6
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Hydrogen Peroxide
Dosage form
RINSE
Route
ORAL
Labeler
Church & Dwight Co., Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-15
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 2x Gum Pain
Brand name suffix
Alcohol-Free
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
adf37010-922c-4441-93d6-1e1a95025e90Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-799-16Orajel 2x Gum Pain Alcohol-Free473.2 mL in 1 BOTTLE, PLASTICRINSE473.22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-799ORAJEL 2X GUM PAIN ALCOHOL-FREE (MENTHOL AND HYDROGEN PEROXIDE) RINSE [CHURCH & DWIGHT CO., INC.]2Current NDC, 1 package rows20241129_adf37010-922c-4441-93d6-1e1a95025e90.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 38 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moon Charcoal Whitening AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c55f7b3-fea1-58f3-e063-6394a90a3bde2023-12-12WarningsExact identifier
application number: M022
ORCA Complete Menthol Pain RelieverMENTHOLORCA Products, LLC99990e27-d66b-4d61-97f2-6a76066eb8b82023-12-08WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc0070858b-e02e-431f-a7c2-313fef01791b2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incd1802f08-80cb-41dd-b34d-9c576b101ddb2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc80182c43-100f-4b15-a07e-819599ab95622023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc19e6426-8f1e-47b3-a3a6-551a5bec6cd92023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1f8431bb-f33c-4fd8-9472-9b59ffb5f18e2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1163d248-d648-443e-bed0-ccb7fd26ba632023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc88caabe2-a096-44d0-98d3-afad1935c0122023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc1b02a2f-db1f-44f0-a74a-d02c085c5bd72023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc39081585-fe6a-4ba1-93f8-d92d26fe75bc2023-12-07WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d7c69357-795c-03d8-e053-2a95a90a03a62023-12-06WarningsExact identifier
application number: M022
Dr. Sheffield Sensitive CareSENSITIVE TOOTH PASTESheffield Pharmaceuticals LLC702a0dec-64cf-4834-8d80-f3d4f0c08a3a2023-11-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCf3bf106c-5320-ced2-e053-2a95a90a71ac2023-11-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0b517321-25ed-2676-e063-6294a90ab4c92023-11-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0b51b67c-03ac-5730-e063-6394a90a50602023-11-29WarningsExact identifier
application number: M022
Pearl WhitePOTASSIUM NITRATE, SODIUM FLUORIDEBeyond International Inc.51c79544-9536-5863-e054-00144ff8d46c2023-11-28WarningsExact identifier
application number: M022
UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDEPOTASSIUM NITRATE AND SODIUM FLUORIDEUniversal Distribution Center LLCfcf59439-7e06-4129-a89f-cdeecdf8d4882023-11-17WarningsExact identifier
application number: M022
PerioRestoreHYDROGEN PEROXIDEDEN-MAT HOLDINGS, LLC.97a07c36-1af8-a636-e053-2a95a90ad6db2023-11-13WarningsExact identifier
application number: M022
Wild Horse 777 OralPHENOLWild Horse 777, Inc.b0b517bb-969f-0c65-e053-2995a90a48b12023-11-10WarningsExact 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 SolutionPSNadf37010-922c-4441-93d6-1e1a95025e902
2584344hydrogen peroxide 15 MG/ML / menthol 1 MG/ML Mucous Membrane Topical SolutionSCDadf37010-922c-4441-93d6-1e1a95025e902
2584344hydrogen peroxide 1.5 % / menthol 0.1 % Mucous Membrane Topical SolutionSYadf37010-922c-4441-93d6-1e1a95025e902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-799-1610237079916473.2 mL in 1 BOTTLE, PLASTIC (10237-799-16) 473.2 ml2023-01-15NoNoCurrent