NDC 51672-2080-01 - Terbinafine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 51672-2080
Requested NDC: 51672-2080-01
Package NDCs from labels: 51672-2080-1, 51672-2080-2, 51672-2080-8, 51672-2080-9, 51672-2080-6, 51672-2080-3, 51672-2080-4, 51672-2080-01
Manufacturer: Preferred Pharmaceuticals, Inc
Effective date: 2026-10-09
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Terbinafine Hydrochloride - Preferred Pharmaceuticals, Inc	Preferred Pharmaceuticals, Inc	2026-10-09	HUMAN OTC DRUG LABEL
Terbinafine Hydrochloride - A-S Medication Solutions	A-S Medication Solutions	2026-09-11	HUMAN OTC DRUG LABEL
Terbinafine Hydrochloride Cream 1% Antifungal Cream	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc.	2026-02-20	HUMAN OTC DRUG LABEL
Terbinafine Hydrochloride - A-S Medication Solutions	A-S Medication Solutions	2023-12-09	HUMAN OTC DRUG LABEL
Terbinafine Hydrochloride - Proficient Rx LP	Proficient Rx LP	2022-07-01	HUMAN OTC DRUG LABEL
Terbinafine Hydrochloride Cream 1% Antifungal Cream	REMEDYREPACK INC.	2021-03-31	HUMAN OTC DRUG LABEL
Terbinafine Hydrochloride Cream 1% Antifungal Cream	Physicians Total Care, Inc.	2014-02-24	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51672-2080-1	Terbinafine Hydrochloride	15 g in 1 TUBE	CREAM	15	6
51672-2080-1	Terbinafine Hydrochloride	1 in 1 CARTON	CREAM	1	6
51672-2080-2	Terbinafine Hydrochloride	30 g in 1 TUBE	CREAM	30	6
51672-2080-2	Terbinafine Hydrochloride	1 in 1 CARTON	CREAM	1	6
51672-2080-3	Terbinafine Hydrochloride	60 g in 1 TUBE	CREAM	60	6
51672-2080-3	Terbinafine Hydrochloride	1 in 1 CARTON	CREAM	1	6
51672-2080-4	Terbinafine Hydrochloride	1 in 1 CARTON	CREAM	1	6
51672-2080-4	Terbinafine Hydrochloride	15 g in 1 TUBE	CREAM	15	6
51672-2080-6	Terbinafine Hydrochloride	1 in 1 CARTON	CREAM	1	6
51672-2080-6	Terbinafine Hydrochloride	45 g in 1 TUBE	CREAM	45	6
51672-2080-8	Terbinafine Hydrochloride	1 in 1 CARTON	CREAM	1	6
51672-2080-8	Terbinafine Hydrochloride	12 g in 1 TUBE	CREAM	12	6
51672-2080-9	Terbinafine Hydrochloride	1 in 1 CARTON	CREAM	1	6
51672-2080-9	Terbinafine Hydrochloride	24 g in 1 TUBE	CREAM	24	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-2080	TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3	Current NDC, Legacy NDC, 14 package rows	20210304_92b31fc4-0f02-4857-b11f-49b9f942ee84.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-2080-1	GM - Gram	51672-2080	5b077eb2-4a3e-4467-b213-af80bebdfea2	1	2012-07-24
51672-2080-2	GM - Gram	51672-2080	b99b56d3-5b68-429b-b864-d7cef0ee2970	1	2012-07-24
51672-2080-8	GM - Gram	51672-2080	250969be-c2ab-423f-9beb-f2c9d68abc05	1	2012-07-24
51672-2080-9	GM - Gram	51672-2080	b03e439e-fc3f-496d-b719-b958636880ea	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Terbinafine Hydrochloride	ACTIVE INGREDIENT	012C11ZU6G	TERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]	2
Terbinafine	ACTIVE MOIETY	G7RIW8S0XP	TERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]	2
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	TERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]	2
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	TERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]	2
cetyl palmitate	INACTIVE INGREDIENT	5ZA2S6B08X	TERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]	2
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	TERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]	2
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	TERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]	2
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	TERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]	2
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	TERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]	2
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	TERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	TERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]	2
Terbinafine Hydrochloride	ACTIVE INGREDIENT	012C11ZU6G	TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]	1
Terbinafine Hydrochloride	ACTIVE INGREDIENT	012C11ZU6G	TERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]	1
Terbinafine Hydrochloride	ACTIVE INGREDIENT	012C11ZU6G	TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
Terbinafine	ACTIVE MOIETY	G7RIW8S0XP	TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]	1
Terbinafine	ACTIVE MOIETY	G7RIW8S0XP	TERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]	1
Terbinafine	ACTIVE MOIETY	G7RIW8S0XP	TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	TERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	TERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
cetyl palmitate	INACTIVE INGREDIENT	5ZA2S6B08X	TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]	1
cetyl palmitate	INACTIVE INGREDIENT	5ZA2S6B08X	TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
cetyl palmitate	INACTIVE INGREDIENT	5ZA2S6B08X	TERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]	1
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]	1
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	TERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]	1
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	TERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	TERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	TERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	TERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	TERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 13 of 14 · 264 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e4a4d764-0922-c85a-e053-2a95a90addd3			d46ef39a-107b-400b-a2be-016834d3f258	2022-07-25	Warnings	Exact identifier spl set id: d46ef39a-107b-400b-a2be-016834d3f258
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Proficient Rx LP	76f7525d-2005-4da8-a795-50ede6236c68	2022-07-01	Warnings	Exact identifier application number: ANDA077511 ndc (package): 63187-111-15 ndc (package): 63187-111-30 ndc (product): 63187-111 rxcui: 992528 spl id: 96ea8a54-d84e-4ac6-9ce1-2624f20a4992 spl set id: 76f7525d-2005-4da8-a795-50ede6236c68 unii: 012C11ZU6G
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Asclemed USA, Inc.	45c38269-883c-4198-a9d5-03810a4420ec	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
TERBINAFINE HYDROCHLORIDE	TERBINAFINE TABLETS 250 MG	Cipla USA Inc.	daf41866-6f2b-4483-b575-456becd6e85f	2021-01-05	Warnings, Adverse reactions	Exact identifier unii: 012C11ZU6G
Terbinafine	TERBINAFINE	Exelan Pharmaceuticals Inc.	6dc279cc-9861-4fa8-8083-ca3b3c57b513	2020-10-29	Warnings, Adverse reactions	Exact identifier unii: 012C11ZU6G
Bach Original Flower Remedies	WATER	Nelson Bach USA Limited	09c76050-42c5-4403-865c-a1f6f668d9c0	2020-06-15	Warnings	Exact identifier unii: 059QF0KO0R
Terbinafine	TERBINAFINE	Proficient Rx LP	3925dc10-ad66-46a8-bfa5-1a4314be3521	2020-01-01	Warnings, Adverse reactions	Exact identifier unii: 012C11ZU6G
Sterile Water	WATER	Baxter Healthcare Company	8bcf5572-49e1-4302-9522-56f57904cb4a	2019-12-29	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Dynamic Eyewash with Eyecup	WATER	Dynamic Safety International	7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2	2018-12-17	Warnings	Exact identifier unii: 059QF0KO0R
Bio Rock Water	ROCK WATER	BioActive Nutritional, Inc.	178bd16d-0d4f-49d8-866b-8ab3a3c6889d	2018-07-30	Warnings	Exact identifier unii: 059QF0KO0R
Ivy-Dry Super	BENZYL ALCOHOL, CAMPHOR, MENTHOL	Ivy-Dry, Inc.	4792a667-2378-4b3d-968d-9efb1866792f	2017-12-27	Warnings	Exact identifier unii: LKG8494WBH
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	808dab18-43f1-4895-a023-edbde722863e	2017-12-15	Warnings, Adverse reactions	Exact identifier unii: 012C11ZU6G
Homeoplex D	GLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,	Supplement Clinic, LLC.	cd6b48ab-3566-484d-8deb-15ef6f8e7e8f	2017-11-01	Warnings	Exact identifier unii: LKG8494WBH unii: 2KR89I4H1Y

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.