Topicale

Product NDC
10733-173
11-digit product format
107330173
Labeler code
10733
Product ID
10733-173_29694bac-976b-0291-e063-6394a90a32d1
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
PATCH
Route
ORAL
Labeler
Medical Products Laboratories, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-06
Substance
BENZOCAINE
Active strength
180 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
Topicale
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE180 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10733-173-01Topicale5 g in 1 CARTONPATCH54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10733-173TOPICALE (BENZOCAINE) PATCH [MEDICAL PRODUCTS LABORATORIES, INC.]4Current NDC, 1 package rows20241218_8282a4a6-b77c-75fc-e053-2991aa0ad4ac.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10733-173-01107330173015 g in 1 CARTON (10733-173-01) 5 g2019-05-06NoNoCurrent