FDA.reportPublic FDA data

Orajel 3X Medicated For All Mouth Sores

Product NDC
10237-783
11-digit product format
102370783
Labeler code
10237
Product ID
10237-783_45c2f5a1-7e8a-1fbd-e063-6394a90ab88f
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
BENZOCAINE; MENTHOL; ZINC CHLORIDE
Active strength
200; 1; 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

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 All Mouth Sores
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g
MENTHOL1 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
U3RSY48JW5Internal UNII lookup
L7T10EIP3AInternal 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
2266762Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
99b589ac-9833-fb60-e053-2995a90a0935Available 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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
10237-783-12Orajel 3X Medicated For All Mouth Sores1 in 1 CARTONGEL15
10237-783-12Orajel 3X Medicated For All Mouth Sores3.5 g in 1 TUBEGEL3.55
10237-783-18Orajel 3X Medicated For All Mouth Sores1 in 1 CARTONGEL15
10237-783-18Orajel 3X Medicated For All Mouth Sores5.1 g in 1 TUBEGEL5.15
10237-783-42Orajel 3X Medicated For All Mouth Sores1 in 1 CARTONGEL15
10237-783-42Orajel 3X Medicated For All Mouth Sores11.9 g in 1 TUBEGEL11.95

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-783ORAJEL 3X MEDICATED FOR ALL MOUTH SORES (BENZOCAINE, MENTHOL, ZINC CHLORIDE) GEL [CHURCH & DWIGHT CO., INC.]4Current NDC, Legacy NDC, 6 package rows20241129_99b589ac-9833-fb60-e053-2995a90a0935.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 24 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.d22f7776-1b3c-4744-bcfe-8d9597218d732025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.9c6a26e8-1253-49f7-9ce2-45c0d39f05c52025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.48178733-7433-41ec-b178-1314e0edab1a2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.af430cf4-f1b4-4b57-b8e3-87df96d655d32025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.2b089fec-cae3-4dc9-964d-d37f732a2f9f2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.6c137a93-4a34-4849-997f-bd0c572466ef2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.e8aa9709-e8f6-47a6-ab29-1fef2309786b2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.8c55b39c-8231-46a1-92ef-9fb4e3f40c1e2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.9e82dc54-aeca-457f-b4b9-2f18cc2695382025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.1a8f5964-770a-4d14-a7b6-18b5da9159b02025-01-16WarningsExact identifier
application number: M022
Top Quality Mfg. Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.7209ceef-9842-400e-89fa-6f4f300536752025-01-16WarningsExact identifier
application number: M022
Top Quality Mfg. Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.1bcb43d9-4e02-443a-8208-dd094f0203b02025-01-16WarningsExact identifier
application number: M022
Top Quality Mfg. Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.fbac0cb4-0ccb-4d9d-9deb-a827c7bc8c662025-01-16WarningsExact identifier
application number: M022
Top Quality Mfg. Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.891d54a9-5cbd-4897-90bf-ade9a3d046fc2025-01-16WarningsExact identifier
application number: M022
Top Quality Mfg. Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.59c03588-5421-4416-a25f-a4778b4d3ea32025-01-16WarningsExact identifier
application number: M022
Top Quality Mfg. Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.68b643c0-a61e-4f68-9791-5f18f4fa8d812025-01-16WarningsExact identifier
application number: M022
Top Quality Mfg. Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.e2e53f9c-5c5c-4771-8345-ff7dcc7bcc4e2025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722cdf3-7671-eb27-e053-2a95a90a09c42025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722bf24-ae85-54f6-e053-2995a90a1d352025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721864d-0950-8379-e053-2a95a90a3bcb2025-01-16WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2266762benzocaine 20 % / menthol 0.1 % / zinc chloride 0.15 % Oral GelPSN99b589ac-9833-fb60-e053-2995a90a09355
2266762benzocaine 0.2 MG/MG / menthol 0.001 MG/MG / zinc chloride 0.0015 MG/MG Oral GelSCD99b589ac-9833-fb60-e053-2995a90a09355
2266762benzocaine 20 % / menthol 0.1 % / zinc chloride 0.15 % Oral GelSY99b589ac-9833-fb60-e053-2995a90a09355

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-783-12102370783121 TUBE in 1 CARTON (10237-783-12) / 3.5 g in 1 TUBE1 tube2019-11-010000-00-00NoNoCurrent
10237-783-18102370783181 TUBE in 1 CARTON (10237-783-18) / 5.1 g in 1 TUBE1 tube2019-11-010000-00-00NoNoCurrent
10237-783-42102370783421 TUBE in 1 CARTON (10237-783-42) / 11.9 g in 1 TUBE1 tube2019-11-010000-00-00NoNoCurrent