Orajel Medicated for Toothache and Gum, Liquid

Product NDC
10237-796
11-digit product format
102370796
Labeler code
10237
Product ID
10237-796_557be35d-65ca-291a-e063-6294a90aac6e
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine and Menthol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Church & Dwight Co., Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-07
Substance
BENZOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength
200; 1 mg/mL; mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 Medicated for Toothache and Gum, Liquid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/mL
MENTHOL, UNSPECIFIED FORM1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2110600Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac3d605d-241d-1a6f-e053-2a95a90ae391Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-796-45Orajel Medicated for Toothache and Gum, Liquid13.3 mL in 1 BOTTLE, GLASSLIQUID13.35
10237-796-45Orajel Medicated for Toothache and Gum, Liquid1 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-796ORAJEL MEDICATED FOR TOOTHACHE AND GUM, LIQUID (BENZOCAINE AND MENTHOL) LIQUID [CHURCH & DWIGHT CO., INC.]4Current NDC, Legacy NDC, 2 package rows20241129_ac3d605d-241d-1a6f-e053-2a95a90ae391.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 17 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oral Pain ReliefBENZOCAINE AND BENZALKONIUM CHLORIDEUniversal Distribution Center LLC18520f9b-4d35-1e9c-e063-6294a90aaa392025-10-30WarningsExact identifier
application number: M022
Iodent Oral AnalgesicBENZOCAINEUnited Exchange Corp.63902125-f8dc-0ada-e053-2991aa0a7ce52025-10-30WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEBETTER LIVING BRANDS, LLC3bded237-4d2c-4b38-bedc-267fdc3741942025-10-29WarningsExact identifier
application number: M022
WALMART SALINESALINE NASAL (SODIUM CHLORIDE)WALMART STORES INC06906744-49a5-4bab-8539-af2d235df9e82025-10-28WarningsExact identifier
application number: M022
SalineNASALPUBLIX SUPER MARKETS, INC19841567-9511-43d6-ba4e-d1e1bd3481a42025-10-28WarningsExact identifier
application number: M022
PUBLIX Sore Throat Fast Relief Oral AnestheticPHENOLPUBLIX SUPER MARKETS, INC89291f12-bbc3-4472-8ad3-a34485af72c92025-10-28WarningsExact identifier
application number: M022
PUBLIX Sore Throat Menthol FlavorPHENOLPUBLIX SUPER MARKETS, INC9296c49e-557c-43ed-9527-fcba5093a8dc2025-10-28WarningsExact identifier
application number: M022
WinCo Foods Maximum Strength Oral AnalgesicBENZOCAINEWinCo Foods, LLCc22a7726-8c3f-41bf-b852-8456b2be6f932025-10-28WarningsExact identifier
application number: M022
Rugby Cherry FlavorPHENOLRUGBY LABORATORIES3d668c78-8130-45d4-bcb7-dddcb2fbe7a32025-10-25WarningsExact identifier
application number: M022
LolliCaine Bubble GumBENZOCAINECentrix, Inc.56ae3a84-6bca-4906-a03d-9d755e1fba3b2025-10-24WarningsExact identifier
application number: M022
Meijer Sore ThroatPHENOLMEIJER DISTRIBUTION INC.360f9756-1cd7-41b2-8ee2-9d1bb7234cf12025-10-24WarningsExact identifier
application number: M022
MEIJER SalineNASALMEIJERa5c6d800-078a-4b66-9d4c-cf3c53f5c1382025-10-24WarningsExact identifier
application number: M022
meijer Maximum Strength Sore Throat Fast ReliefPHENOL AND GLYCERINMEIJER DISTRIBUTION INCf1f17aab-7ea7-4dac-a854-48b4b560ec4f2025-10-24WarningsExact identifier
application number: M022
Diabetic Tussin Sore Throat CherryPHENOLMEDTECH PRODUCTS INCab351229-5771-4c6c-92a8-721cc41c002f2025-10-23WarningsExact identifier
application number: M022
Chloraseptic Total Sore Throat and Cough, Sugar FreeMENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEPrestige Brands Holdings, Inc.34e4234c-ed61-4795-99fe-d281cdb0af882025-10-23WarningsExact identifier
application number: M022
Chloraseptic Total Sore Throat and CoughMENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDEPrestige Brands Holdings, Inc.6b1a50d0-be54-4fcb-b5e2-b47abf3555c02025-10-23WarningsExact identifier
application number: M022
Chloraseptic Childrens Sore Throat CherryPHENOLPrestige Brands Holdings, Inc.38ff6922-1abe-4fa9-a74e-ede604f707b52025-10-23WarningsExact identifier
application number: M022
Boka SensitivePOTASSIUM NITRATEKaraka LLC40be9fab-53db-c67a-e063-6394a90a48cb2025-10-23WarningsExact identifier
application number: M022
Canker Care PlusMENTHOL, UNSPECIFIED FORMQuantum, Inc.1ec960db-52d5-4d99-a7f7-a2e538d287242025-10-20WarningsExact identifier
application number: M022
meijer Sensitive EXTRA WHITENINGPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.bbcffb88-0bd4-4883-bb83-0b7a1428ad122025-10-20WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2110600benzocaine 20 % / menthol 0.1 % Mucous Membrane Topical SolutionPSNac3d605d-241d-1a6f-e053-2a95a90ae3915
2110600benzocaine 200 MG/ML / menthol 1 MG/ML Mucous Membrane Topical SolutionSCDac3d605d-241d-1a6f-e053-2a95a90ae3915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10237-796-45102370796451 BOTTLE, GLASS in 1 CARTON (10237-796-45) / 13.3 mL in 1 BOTTLE, GLASS2020-08-070000-00-00NoNoCurrent