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Terbinafine Hydrochloride
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Terbinafine Hydrochloride | 1 g/100g | 992528 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Allylamine Antifungal [EPC] | EPC | All 11 members |
| Allylamine [CS] | CS | All 11 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 077511-001 | TERBINAFINE HYDROCHLORIDE | CREAM | TERBINAFINE HYDROCHLORIDE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUses • 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
openFDA Drug LabelingPurpose Antifungal
Dosage and Administration
openFDA Drug LabelingDirections • 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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo not use • on nails or scalp • in or near the mouth or the eyes • for vaginal yeast infections
Stop Use
openFDA Drug LabelingStop 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 LabelingActive ingredient Terbinafine hydrochloride 1%
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Product: 50090-1278 NDC: 50090-1278-0 15 g in a TUBE / 1 in a CARTON
Adverse event reports
Source: openFDA FAERSAttributed 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| 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
| 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.