FDA.reportPublic FDA data

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#

Effective, Related label table
EffectiveRelated label
2024-02-05Orajel Medicated for Toothache and Gum, Liquid
2024-02-05Orajel 2x Medicated for Toothache and Gum, Liquid
2023-01-30Orajel Medicated for Toothache and Gum, Liquid
2023-01-30Orajel 2x Medicated for Toothache and Gum, Liquid

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 10 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Scope All Day CPC Antigingivitis/Antiplaque Mouthwash All DayCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd5f69341-b659-c74a-e053-2a95a90a317e2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Breath Purify and Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd71ed31f-cc33-2fc3-e053-2995a90ad39b2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health ClinicalCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company0a295ee0-55c2-4f21-8f0a-70efc0e516942026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd721e2cb-8f67-3d07-e053-2995a90ae65a2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health AdvantageCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyddcd56fe-25d6-8195-e053-2a95a90a575a2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Bacteria GuardCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc2dc1f31-625d-a032-e053-2995a90a730d2026-01-08WarningsExact identifier
application number: M022
Crest Pro Health Gum plus Bacteria GuardCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc598a4ab-5981-0068-e053-2a95a90af4fa2026-01-08WarningsExact identifier
application number: M022
Oral B Gum Detoxify Special Care RinseCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyc2dcdde4-5542-1f87-e053-2995a90a261c2026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Intense Fresh MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company62991165-ec81-48a8-e053-2991aa0a54f32026-01-08WarningsExact identifier
application number: M022
Crest Gum CareCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company72f1a02f-1d02-7e83-e053-2a91aa0a79472026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Intense Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company6287bc3e-8b05-45d3-e053-2991aa0aaa102026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Multi-Protection Refreshing Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company8867d791-7e93-4f39-aaaf-bfbee8296fd92026-01-08WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum CreamBENZOCAINEHEBa71c5259-cbcf-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
application number: M022
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLC387d264c-90cc-5e67-e063-6394a90a713d2026-01-08WarningsExact identifier
application number: M022
TopCare Sensitive Extra WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDETOPCO Assoc. LLC835f41cf-e920-7df7-e053-2a91aa0a44792026-01-08WarningsExact identifier
application number: M022
Scope Icy BlastCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company164ed151-01d3-021a-e063-6294a90a0e512026-01-08WarningsExact identifier
application number: M022
Crest Pro-Health Advanced Enamel CareSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company1660e7d7-5b8d-8aba-e063-6294a90a50d82026-01-08WarningsExact identifier
application number: M022
Crest Deep Cleanse Germ TreatmentCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company2d6b15d4-7827-ec2f-e063-6294a90a82c82026-01-08WarningsExact identifier
application number: M022
Crest Scope OriginalCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company21eed451-9368-146c-e063-6294a90af62b2026-01-08WarningsExact identifier
application number: M022
3x Medicated Mouth Sore GelBENZOCAINEHEBa71c5259-cbd1-7566-e053-2995a90a2cb62026-01-08WarningsExact 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