FDA.reportPublic FDA data

Orajel 3X Medicated For Toothache and Gum

Product NDC
10237-790
11-digit product format
102370790
Labeler code
10237
Product ID
10237-790_45c2eb22-063f-1dd9-e063-6394a90aae42
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine, Menthol, Zinc chloride
Dosage form
GEL
Route
TOPICAL
Labeler
Church & Dwight Co., Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-01
Substance
MENTHOL; BENZOCAINE; ZINC CHLORIDE
Active strength
2.6; 200; 1.5 mg/g; mg/g; mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10237-79010237-790-12DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10237-79010237-790-12DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10237-79010237-790-12DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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 3X Medicated For Toothache and Gum
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2.6 mg/g
BENZOCAINE200 mg/g
ZINC CHLORIDE1.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
U3RSY48JW5Internal UNII lookup
86Q357L16BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2362013Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
99a2b061-0875-59a4-e053-2995a90ab373Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-790-12Orajel 3X Medicated For Toothache and Gum3.5 g in 1 TUBEGEL3.511
10237-790-12Orajel 3X Medicated For Toothache and Gum1 in 1 CARTONGEL111
10237-790-25Orajel 3X Medicated For Toothache and Gum1 in 1 CARTONGEL111
10237-790-25Orajel 3X Medicated For Toothache and Gum7 g in 1 TUBEGEL711
10237-790-42Orajel 3X Medicated For Toothache and Gum1 in 1 CARTONGEL111
10237-790-42Orajel 3X Medicated For Toothache and Gum11.9 g in 1 TUBEGEL11.911

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-790ORAJEL 3X MEDICATED FOR TOOTHACHE AND GUM (BENZOCAINE, MENTHOL, ZINC CHLORIDE) GEL [CHURCH & DWIGHT CO., INC.]10Current NDC, Legacy NDC, 6 package rows20241129_99a2b061-0875-59a4-e053-2995a90ab373.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 18 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Essential CareSODIUM MONOFLUOROPHOSPHATEKenvue Brands LLC90b5c3d8-baa4-44ab-8f73-e177007f02192025-10-10WarningsExact identifier
application number: M022
DuoCare Clinical Oral RinseCETYLPYRIDINIUM CHLORIDEMedline Industries, LP98e61cd5-7e29-7066-e053-2a95a90afa212025-10-10WarningsExact identifier
application number: M022
4-in-1 Teeth Care Pens4-IN-1 TEETH CARE PENSJiangxi Dentalbright Technology Co., Ltd40b756b7-ce1b-6482-e063-6294a90a04252025-10-09WarningsExact identifier
application number: M022
Giltuss BucalsepBENZOCAINE, MENTHOL, ZINC CHLORIDEGil Pharmaceutical Corp85053391-8d71-ab4f-e053-2991aa0a7e082025-10-09WarningsExact identifier
application number: M022
Listerine Gum Therapy Mouthwash Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC40a0bdf3-1698-1449-e063-6394a90ab13d2025-10-08WarningsExact identifier
application number: M022
Kalaya Breath RefreshMOUTHWASHAvaria Health and Beauty Corp750e99ff-72e4-3c2f-e053-2a91aa0ad5a02025-10-08WarningsExact identifier
application number: M022
Trader JoesSODIUM FLUORIDE 0.24% AND POTASSIUM NITRATE 5%TRADER JOE'S COMPANY159abeba-6da2-2643-e063-6394a90a730d2025-10-08WarningsExact identifier
application number: M022
Family Wellness Oral Pain ReliefBENZOCAINE 20%FAMILY DOLLAR SERVICES INC105d87d6-9147-43d4-e063-6394a90a57ee2025-10-08WarningsExact identifier
application number: M022
Equate Glistening MintSODIUM FLUORIDEWalmart Inc.39ff21ee-a362-014e-e063-6294a90a0d912025-10-03WarningsExact identifier
application number: M022
Mouth Sore Relief Professional StrengthBENZOCAINECVS Pharmacy1b7209f6-8368-47fa-8df2-b049613b8c1b2025-09-30WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEFamily Dollar (FAMILY WELLNESS)9db73da2-5b70-41e6-bcf9-caa7f11420242025-09-29WarningsExact identifier
application number: M022
Esunix Oral Bacteriostatic LiquidCETYLPYRIDINIUM CHLORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f47d7e1-b6ae-efd1-e063-6394a90a46022025-09-27WarningsExact identifier
application number: M022
Chloraseptic Sore Throat CherryPHENOLPrestige Brands Holdings, Inc.d5d62f7a-8f92-4d42-a2fb-691f896f72fc2025-09-26WarningsExact identifier
application number: M022
Giltuss BucalsepBENZOCAINE, MENTHOL, ZINC CHLORIDEDextrum Laboratories Inc.3fa233dc-156c-1e95-e063-6294a90a8bbd2025-09-25WarningsExact identifier
application number: M022
Finafta MultiOralBENZOCAINEDextrum Laboratories Inc.cb027ab8-4175-4cc0-a73e-991dfb113df92025-09-23WarningsExact identifier
application number: M022
4-in-1 Teeth Care Pens4-IN-1 TEETH CARE PENSJiangxi Dentalbright Technology Co., Ltd3f872924-0c44-267b-e063-6394a90a1a672025-09-23WarningsExact identifier
application number: M022
Dental ReliefBENZOCAINECintas Corporation0f40f775-797e-43cf-88c9-00eea666494f2025-09-23WarningsExact identifier
application number: M022
Seavue Anti-caries GelSODIUM FLUORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f4c6086-b96d-8fa4-e063-6294a90ad8002025-09-21WarningsExact identifier
application number: M022
Seavue Dental DesensitizerPOTASSIUM NITRATE AND SODIUM FLUORIDE DENTIFRICEXiling (Zhenjiang) Medical Technology Co., Ltd.3f47f399-1a14-5264-e063-6394a90aeb1c2025-09-20WarningsExact identifier
application number: M022
Povi-OnePOVIDONE-IODINE 10% TOPICALElevate Oral Care27c29a33-d1cc-d72f-e063-6394a90a4d452025-09-19WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2362013benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral GelPSN99a2b061-0875-59a4-e053-2995a90ab37311
2362013benzocaine 0.2 MG/MG / menthol 0.0026 MG/MG / zinc chloride 0.0015 MG/MG Oral GelSCD99a2b061-0875-59a4-e053-2995a90ab37311
2362013benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral GelSY99a2b061-0875-59a4-e053-2995a90ab37311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-790-12102370790121 TUBE in 1 CARTON (10237-790-12) / 3.5 g in 1 TUBE1 tube2019-11-010000-00-00NoNoCurrent
10237-790-25102370790251 TUBE in 1 CARTON (10237-790-25) / 7 g in 1 TUBE1 tube2019-11-010000-00-00NoNoCurrent
10237-790-42102370790421 TUBE in 1 CARTON (10237-790-42) / 11.9 g in 1 TUBE1 tube2019-11-010000-00-00NoNoCurrent