FDA.reportPublic FDA data

Orajel 3X Medicated For Toothache and Gum

Product NDC
10237-790
11-digit product format
102370790
Labeler code
10237
Product ID
10237-790_45c2eb22-063f-1dd9-e063-6394a90aae42
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; 2.6; 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

Additional Listing Data#

Finished product
Yes
Brand name base
Orajel 3X Medicated For Toothache and Gum
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g
MENTHOL2.6 mg/g
ZINC CHLORIDE1.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5, L7T10EIP3A, 86Q357L16B
Rxcui2362013

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
10237-790-12Orajel 3X Medicated For Toothache and Gum3.5 g in 1 TUBEGEL3.511
10237-790-12Orajel 3X Medicated For Toothache and Gum1 in 1 CARTONGEL111
10237-790-25Orajel 3X Medicated For Toothache and Gum1 in 1 CARTONGEL111
10237-790-25Orajel 3X Medicated For Toothache and Gum7 g in 1 TUBEGEL711
10237-790-42Orajel 3X Medicated For Toothache and Gum1 in 1 CARTONGEL111
10237-790-42Orajel 3X Medicated For Toothache and Gum11.9 g in 1 TUBEGEL11.911

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-790ORAJEL 3X MEDICATED FOR TOOTHACHE AND GUM (BENZOCAINE, MENTHOL, ZINC CHLORIDE) GEL [CHURCH & DWIGHT CO., INC.]10Current NDC, Legacy NDC, 6 package rows20241129_99a2b061-0875-59a4-e053-2995a90ab373.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2362013benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral GelPSN99a2b061-0875-59a4-e053-2995a90ab37311
2362013benzocaine 0.2 MG/MG / menthol 0.0026 MG/MG / zinc chloride 0.0015 MG/MG Oral GelSCD99a2b061-0875-59a4-e053-2995a90ab37311
2362013benzocaine 20 % / menthol 0.26 % / zinc chloride 0.15 % Oral GelSY99a2b061-0875-59a4-e053-2995a90ab37311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-790-12102370790121 TUBE in 1 CARTON (10237-790-12) / 3.5 g in 1 TUBE1 tube2019-11-010000-00-00NoNoCurrent
10237-790-25102370790251 TUBE in 1 CARTON (10237-790-25) / 7 g in 1 TUBE1 tube2019-11-010000-00-00NoNoCurrent
10237-790-42102370790421 TUBE in 1 CARTON (10237-790-42) / 11.9 g in 1 TUBE1 tube2019-11-010000-00-00NoNoCurrent