FDA.reportPublic FDA data

Orajel 4X Medicated For Toothache and Gum

Product NDC
10237-787
11-digit product format
102370787
Labeler code
10237
Product ID
10237-787_45c2eac1-8aed-0f2f-e063-6294a90a0602
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride, 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
BENZOCAINE; MENTHOL, UNSPECIFIED FORM; BENZALKONIUM CHLORIDE; ZINC CHLORIDE
Active strength
200; 5; 1.3; 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g
MENTHOL, UNSPECIFIED FORM5 mg/g
BENZALKONIUM CHLORIDE1.3 mg/g
ZINC CHLORIDE1.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
L7T10EIP3AInternal UNII lookup
F5UM2KM3W7Internal 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
2369638Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
999851ac-925c-7d1f-e053-2a95a90a240bAvailable 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
10237-787-25Orajel 4X Medicated For Toothache and Gum1 in 1 CARTONGEL19
10237-787-25Orajel 4X Medicated For Toothache and Gum7 g in 1 TUBEGEL79

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-787ORAJEL 4X MEDICATED FOR TOOTHACHE AND GUM (BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE) GEL [CHURCH & DWIGHT CO., INC.]8Current NDC, Legacy NDC, 2 package rows20241129_999851ac-925c-7d1f-e053-2a95a90a240b.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 26 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BurkhartSTANNOUS FLUORIDEBurkhart Dental Supply Inc048c9978-e32e-4f77-9a4e-40acd5fcdfaf2025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incaa09dcc0-e641-4c6d-8a84-ba890c0fce4c2025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc4255da05-d264-4a4c-bd67-53d4862c06822025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc2282ea74-94c1-40be-a77f-290763a762502025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc99bce4c6-4593-40a1-b28d-8334a79b9d422025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incaa233c68-c6ac-44a5-b50e-3f5cd843bd252025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incbb11bfb4-1b50-48c6-8273-452b47b478332025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc867cef7b-fe6e-4a45-87c1-35579a681c6c2025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incc6238079-0bcc-4c35-9b73-455252d41ee52025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incb144aca9-91d1-4106-a39c-b928192ad41e2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.0192ccf9-1715-4e23-a6bf-8bd838cd8b0d2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.edcb8451-6fa7-4bc2-95f6-2a0806f7f3da2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.576660ed-203a-4842-9d39-c5be10daf9762025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.1796b3ec-833a-4cf1-ba50-bc4da827f84f2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.d923fa75-f556-45e3-9f52-39a62e89984b2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.cd3ede8c-2c77-4d81-8dff-8198025a21562025-01-09WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCcb7f5f9b-4192-15e6-e053-2995a90a64572025-01-09WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLC2b494372-de59-e462-e063-6294a90a08da2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Citya225d515-430d-4e34-846c-0bfec3e741092025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City372f99c9-4ad3-4631-b8c8-2a34c47343cc2025-01-09WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2369638benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.5 % / zinc chloride 0.15 % Oral GelPSN999851ac-925c-7d1f-e053-2a95a90a240b9
2369638benzalkonium chloride 0.0013 MG/MG / benzocaine 0.2 MG/MG / menthol 0.005 MG/MG / zinc chloride 0.0015 MG/MG Oral GelSCD999851ac-925c-7d1f-e053-2a95a90a240b9
2369638benzalkonium chloride 0.13 % / benzocaine 20 % / menthol 0.5 % / zinc chloride 0.15 % Oral GelSY999851ac-925c-7d1f-e053-2a95a90a240b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-787-25102370787251 TUBE in 1 CARTON (10237-787-25) / 7 g in 1 TUBE1 tube2019-11-010000-00-00NoNoCurrent