FDA.reportPublic FDA data

Orajel 2X Medicated Gel

Product NDC
10237-782
11-digit product format
102370782
Labeler code
10237
Product ID
10237-782_262be295-4eb0-3136-e063-6294a90a7dcc
Type
HUMAN OTC DRUG
Nonproprietary name
Oral Pain Reliever
Dosage form
GEL
Route
TOPICAL
Labeler
Church & Dwight Co., Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-23
Substance
BENZOCAINE; MENTHOL
Active strength
200; 2.6 mg/g; mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [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 2X Medicated Gel
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5, L7T10EIP3A
Rxcui2117337

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-782-25Orajel 2X Medicated Gel7 g in 1 TUBEGEL71
10237-782-25Orajel 2X Medicated Gel1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-782ORAJEL 2X MEDICATED GEL (ORAL PAIN RELIEVER) GEL [CHURCH & DWIGHT CO., INC.]1Current NDC, 2 package rows20241109_262be295-4eaf-3136-e063-6294a90a7dcc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2117337benzocaine 20 % / menthol 0.26 % Oral GelPSN262be295-4eaf-3136-e063-6294a90a7dcc1
2117337benzocaine 0.2 MG/MG / menthol 0.0026 MG/MG Oral GelSCD262be295-4eaf-3136-e063-6294a90a7dcc1
2117337benzocaine 20 % / menthol 0.26 % Oral GelSY262be295-4eaf-3136-e063-6294a90a7dcc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-782-25102370782251 TUBE in 1 CARTON (10237-782-25) / 7 g in 1 TUBE1 tube2022-05-23NoNoCurrent