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Terbinafine Hydrochloride

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Terbinafine Hydrochloride
Generic name
Terbinafine Hydrochloride
Dosage form
Cream
Route
Topical
Marketing category
ANDA · ANDA
Labeler
A-S Medication Solutions
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
10
Packages
17
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Terbinafine Hydrochloride 1 g/100g 992528 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Cream
Route of administration
Topical
Presentations
27

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Allylamine Antifungal [EPC] EPC All 11 members
Allylamine [CS] CS All 11 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
077511
Application type
ANDA · Abbreviated New Drug Application
Approval date
July 2, 2007
Sponsor
SUN PHARMA CANADA
Products on application
1
Submissions recorded
3
Products approved under application 077511.
Product Trade name Form Strength Ingredient Status TE Flags
077511-001 TERBINAFINE HYDROCHLORIDE CREAM TERBINAFINE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 077511.
Type No. Action Status Date Review
Supplement 15 Labeling Approved February 28, 2019 Standard
Supplement 5 Manufacturing (CMC) Approved October 22, 2014 —
Original application 1 Approved July 2, 2007 —

Review documents

  • 0 · Original application · March 28, 2012

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250930). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250930 HUMAN OTC DRUG · 20231209

Indications and Usage

openFDA Drug Labeling

Uses • cures most athlete's foot (tinea pedis) • cures most jock itch (tinea cruris) and ringworm (tinea corporis) • relieves itching, burning, cracking and scaling which accompany these conditions

Purpose Antifungal

Dosage and Administration

openFDA Drug Labeling

Directions • adults and children 12 years and older o use the tip of the cap to break the seal and open the tube o wash the affected skin with soap and water and dry completely before applying o for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. ▪ between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor. ▪ on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor. o for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor. o wash hands after each use • children under 12 years: ask a doctor 1 week between the toes 2 weeks on the bottom or sides of the foot Figure 1 Figure 2

Warnings For external use only Do not use • on nails or scalp • in or near the mouth or the eyes • for vaginal yeast infections When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and ask a doctor if • too much irritation occurs or gets worse. • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Do not use • on nails or scalp • in or near the mouth or the eyes • for vaginal yeast infections

Stop use and ask a doctor if • too much irritation occurs or gets worse. • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Active Ingredient

openFDA Drug Labeling

Active ingredient Terbinafine hydrochloride 1%

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-1278 NDC: 50090-1278-0 15 g in a TUBE / 1 in a CARTON

Adverse event reports

Source: openFDA FAERS
8,840
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: TERBINAFINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
50090-1278-0 50090-1278 A-S Medication Solutions 1 TUBE in 1 CARTON (50090-1278-0) / 15 g in 1 TUBE November 28, 2014
50090-5810-0 50090-5810 A-S Medication Solutions 1 TUBE in 1 CARTON (50090-5810-0) / 30 g in 1 TUBE October 15, 2021
70000-0338-1 70000-0338 Cardinal Health, 110 dba LEADER 1 TUBE in 1 CARTON (70000-0338-1) / 15 g in 1 TUBE July 30, 2018
68788-9814-1 68788-9814 Preferred Pharmaceuticals, Inc 15 g in 1 TUBE (68788-9814-1) April 5, 2012
63187-111-15 63187-111 Proficient Rx LP 1 TUBE in 1 CARTON (63187-111-15) / 15 g in 1 TUBE December 1, 2018
63187-111-30 63187-111 Proficient Rx LP 1 TUBE in 1 CARTON (63187-111-30) / 30 g in 1 TUBE December 1, 2018
70677-1003-1 70677-1003 STRATEGIC SOURCING SERVICES LLC 1 TUBE in 1 CARTON (70677-1003-1) / 30 g in 1 TUBE June 30, 2023
73469-7215-2 73469-7215 Scholl's Wellness Company LLC 1 TUBE in 1 CARTON (73469-7215-2) / 30 g in 1 TUBE September 11, 2025
51672-2080-1 51672-2080 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-2080-1) / 15 g in 1 TUBE July 2, 2007
51672-2080-2 51672-2080 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-2080-2) / 30 g in 1 TUBE July 2, 2007
51672-2080-3 51672-2080 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-2080-3) / 60 g in 1 TUBE July 2, 2007
51672-2080-4 51672-2080 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-2080-4) / 15 g in 1 TUBE April 24, 2017
51672-2080-6 51672-2080 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-2080-6) / 45 g in 1 TUBE July 2, 2007
51672-2080-8 51672-2080 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-2080-8) / 12 g in 1 TUBE July 2, 2007
51672-2080-9 51672-2080 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-2080-9) / 24 g in 1 TUBE July 2, 2007
51672-2140-1 51672-2140 Sun Pharmaceutical Industries, Inc. 1 TUBE in 1 CARTON (51672-2140-1) / 15 g in 1 TUBE February 28, 2019
0363-4502-02 0363-4502 WALGREEN COMPANY 1 TUBE in 1 CARTON (0363-4502-02) / 30 g in 1 TUBE October 25, 2023
50090-1278 50090-1278 A-S Medication Solutions — July 2, 2007
50090-5810 50090-5810 A-S Medication Solutions — July 2, 2007
70000-0338 70000-0338 Cardinal Health, 110 dba LEADER — July 30, 2018
68788-9814 68788-9814 Preferred Pharmaceuticals, Inc — April 5, 2012
63187-111 63187-111 Proficient Rx LP — July 2, 2007
70677-1003 70677-1003 STRATEGIC SOURCING SERVICES LLC — June 30, 2023
73469-7215 73469-7215 Scholl's Wellness Company LLC — September 11, 2025
51672-2080 51672-2080 Sun Pharmaceutical Industries, Inc. — July 2, 2007
51672-2140 51672-2140 Sun Pharmaceutical Industries, Inc. — July 2, 2007
0363-4502 0363-4502 WALGREEN COMPANY — October 25, 2023

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.