Jock Itch

Product NDC
51672-2101
11-digit product format
516722101
Labeler code
51672
Product ID
51672-2101_3907ca33-83bf-59c5-e063-6294a90a6aaa
Type
HUMAN OTC DRUG
Nonproprietary name
Butenafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA205181
Marketing category
ANDA
Marketing start
2017-11-17
Substance
BUTENAFINE HYDROCHLORIDE
Active strength
10 mg/g
Pharmacologic classes
Benzylamine Antifungal [EPC], Benzylamines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Jock Itch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTENAFINE HYDROCHLORIDE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR8XA2029ZI
Rxcui1298448

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2101-1Jock Itch1 in 1 CARTONCREAM16
51672-2101-1Jock Itch15 g in 1 TUBECREAM156
51672-2101-2Jock Itch1 in 1 CARTONCREAM16
51672-2101-2Jock Itch30 g in 1 TUBECREAM306
51672-2101-8Jock Itch1 in 1 CARTONCREAM16
51672-2101-8Jock Itch12 g in 1 TUBECREAM126
51672-2101-9Jock Itch1 in 1 CARTONCREAM16
51672-2101-9Jock Itch24 g in 1 TUBECREAM246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2101JOCK ITCH (BUTENAFINE HYDROCHLORIDE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4Current NDC, Legacy NDC, 8 package rows20171121_14a23a39-b567-4db4-bac0-c008c0ca6171.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298448butenafine HCl 1 % Topical CreamPSN14a23a39-b567-4db4-bac0-c008c0ca61716
1298448butenafine hydrochloride 10 MG/ML Topical CreamSCD14a23a39-b567-4db4-bac0-c008c0ca61716
1298448butenafine HCl 1 % Topical CreamSY14a23a39-b567-4db4-bac0-c008c0ca61716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2101-1516722101011 TUBE in 1 CARTON (51672-2101-1) / 15 g in 1 TUBE1 tube2017-11-170000-00-00NoNoCurrent
51672-2101-2516722101021 TUBE in 1 CARTON (51672-2101-2) / 30 g in 1 TUBE1 tube2017-11-170000-00-00NoNoCurrent
51672-2101-8516722101081 TUBE in 1 CARTON (51672-2101-8) / 12 g in 1 TUBE1 tube2017-11-170000-00-00NoNoCurrent
51672-2101-9516722101091 TUBE in 1 CARTON (51672-2101-9) / 24 g in 1 TUBE1 tube2017-11-170000-00-00NoNoCurrent