FDA.reportPublic FDA data

Orajel 4X Medicated For Toothache and Gum, Cream

Product NDC
10237-788
11-digit product format
102370788
Labeler code
10237
Product ID
10237-788_45c2f5a1-7e8d-1fbd-e063-6394a90ab88f
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Church & Dwight Co., Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-01
Substance
BENZALKONIUM CHLORIDE; BENZOCAINE; MENTHOL, UNSPECIFIED FORM; ZINC CATION
Active strength
1.3; 200; 2.6; 1.5 mg/g; 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

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 4X Medicated For Toothache and Gum, Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/g
BENZOCAINE200 mg/g
MENTHOL, UNSPECIFIED FORM2.6 mg/g
ZINC CATION1.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup
U3RSY48JW5Internal UNII lookup
L7T10EIP3AInternal UNII lookup
13S1S8SF37Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2370903Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
999aa7b9-bf9e-9285-e053-2a95a90a345bAvailable 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
10237-788-33Orajel 4X Medicated For Toothache and Gum, Cream9.4 g in 1 TUBECREAM9.47
10237-788-33Orajel 4X Medicated For Toothache and Gum, Cream1 in 1 CARTONCREAM17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-788ORAJEL 4X MEDICATED FOR TOOTHACHE AND GUM, CREAM (BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE) CREAM [CHURCH & DWIGHT CO., INC.]6Current NDC, Legacy NDC, 2 package rows20241129_999aa7b9-bf9e-9285-e053-2a95a90a345b.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 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Maximum Strength Oral Pain RelievingBENZOCAINEChain Drug Marketing Association Incdbde8e7f-85d8-4083-b01a-3a7e410a77472025-10-17WarningsExact identifier
application number: M022
Quality ChoiceBENZOCAINEChain Drug Marketing Association, Inc.24c3c4a3-bd76-198d-e063-6394a90ad45a2025-10-16WarningsExact identifier
application number: M022
Sore Throat Relief Cherry FlavorPHENOLCardinal Healthb84203bd-23e9-427d-83d8-f4c88266e23c2025-10-14WarningsExact identifier
application number: M022
FinaftaBENZOCAINE, GLYCERINEfficient Laboratories Inc.03368603-3e11-c2fa-e063-6294a90a04ea2025-10-14WarningsExact identifier
application number: M022
Sensodyne Pronamel Clinical Enamel Strength Whitening ActionPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCe8a62f24-1db6-45fb-b6e1-5e57103f82bc2025-10-14WarningsExact identifier
application number: M022
evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINTPOTASSIUM NITRATE, SODIUM FLUORIDEAshtel Studios, Inc.bc74d2a6-fe34-44cf-b015-70ed4d47c9332025-10-13WarningsExact identifier
application number: M022
Listerine Essential CareSODIUM MONOFLUOROPHOSPHATEKenvue Brands LLC90b5c3d8-baa4-44ab-8f73-e177007f02192025-10-10WarningsExact identifier
application number: M022
Anesgerm LA MUELA Fast Pain ReliefBENZOCAINE 20%Germa Products, LLCbf7842a2-9c0b-3fc3-e053-2995a90a36c12025-10-10WarningsExact identifier
application number: M022
Aftaseptic Instant Pain ReliefSALISYLIC ACID 1%Germa Products, LLCbeb32fba-503a-f5e5-e053-2a95a90a57e52025-10-10WarningsExact 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
Vicks VapoCool Sore ThroatBENZOCAINE AND MENTHOLThe Procter & Gamble Manufacturing Company8749824b-6d04-430d-e053-2995a90a2db82025-10-06WarningsExact identifier
application number: M022
Vicks VapoCool SEVEREMENTHOLThe Procter & Gamble Manufacturing Companyc77f8878-5eef-b006-e053-2a95a90a18662025-10-03WarningsExact identifier
application number: M022
Vicks VapoCOOL SEVEREMENTHOLThe Procter & Gamble Manufacturing Company042b6ea0-baf3-52d2-e063-6394a90ac6fb2025-10-03WarningsExact identifier
application number: M022
Equate Glistening MintSODIUM FLUORIDEWalmart Inc.39ff21ee-a362-014e-e063-6294a90a0d912025-10-03WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamPSN999aa7b9-bf9e-9285-e053-2a95a90a345b7
2370903benzalkonium chloride 1.3 MG/ML / benzocaine 200 MG/ML / menthol 2.6 MG/ML / zinc chloride 1.5 MG/ML Oral CreamSCD999aa7b9-bf9e-9285-e053-2a95a90a345b7
2370903benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral CreamSY999aa7b9-bf9e-9285-e053-2a95a90a345b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-788-33102370788331 TUBE in 1 CARTON (10237-788-33) / 9.4 g in 1 TUBE1 tube2019-11-010000-00-00NoNoCurrent