jock itch

Generic: butenafine hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name jock itch
Generic Name butenafine hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

butenafine hydrochloride 10 mg/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-2101
Product ID 51672-2101_3907ca33-83bf-59c5-e063-6294a90a6aaa
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA205181
Listing Expiration 2026-12-31
Marketing Start 2017-11-17

Pharmacologic Class

Classes
benzylamine antifungal [epc] benzylamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516722101
Hyphenated Format 51672-2101

Supplemental Identifiers

RxCUI
1298448
UNII
R8XA2029ZI

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name jock itch (source: ndc)
Generic Name butenafine hydrochloride (source: ndc)
Application Number ANDA205181 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51672-2101-1) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-2101-2) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-2101-8) / 12 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-2101-9) / 24 g in 1 TUBE
source: ndc

Packages (4)

51672-2101-1 1 TUBE in 1 CARTON (51672-2101-1) / 15 g in 1 TUBE 51672-2101-2 1 TUBE in 1 CARTON (51672-2101-2) / 30 g in 1 TUBE 51672-2101-8 1 TUBE in 1 CARTON (51672-2101-8) / 12 g in 1 TUBE 51672-2101-9 1 TUBE in 1 CARTON (51672-2101-9) / 24 g in 1 TUBE

Ingredients (1)

butenafine hydrochloride (10 mg/g)

Linked Drug Pages (1)

Jock Itch ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3907ca33-83bf-59c5-e063-6294a90a6aaa", "openfda": {"unii": ["R8XA2029ZI"], "rxcui": ["1298448"], "spl_set_id": ["14a23a39-b567-4db4-bac0-c008c0ca6171"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-2101-1)  / 15 g in 1 TUBE", "package_ndc": "51672-2101-1", "marketing_start_date": "20171117"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-2101-2)  / 30 g in 1 TUBE", "package_ndc": "51672-2101-2", "marketing_start_date": "20171117"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-2101-8)  / 12 g in 1 TUBE", "package_ndc": "51672-2101-8", "marketing_start_date": "20171117"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-2101-9)  / 24 g in 1 TUBE", "package_ndc": "51672-2101-9", "marketing_start_date": "20171117"}], "brand_name": "Jock Itch", "product_id": "51672-2101_3907ca33-83bf-59c5-e063-6294a90a6aaa", "dosage_form": "CREAM", "pharm_class": ["Benzylamine Antifungal [EPC]", "Benzylamines [CS]"], "product_ndc": "51672-2101", "generic_name": "Butenafine Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Jock Itch", "active_ingredients": [{"name": "BUTENAFINE HYDROCHLORIDE", "strength": "10 mg/g"}], "application_number": "ANDA205181", "marketing_category": "ANDA", "marketing_start_date": "20171117", "listing_expiration_date": "20261231"}