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 11 of 14 · 264 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Breckenridge Pharmaceutical, Inc.	c3832113-f517-4b4e-bf9c-31fce1a638e1	2023-12-22	Warnings, Adverse reactions	Exact identifier unii: 012C11ZU6G
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	A-S Medication Solutions	ef8370dc-8ca4-411d-87e1-dc6af3191330	2023-12-09	Warnings	Exact identifier application number: ANDA077511 ndc (package): 50090-1278-0 ndc (product): 50090-1278 rxcui: 992528 spl id: d0db1c47-4dfe-443e-a514-09f727fb0b9f spl set id: ef8370dc-8ca4-411d-87e1-dc6af3191330 unii: 012C11ZU6G
Eye Wash	WATER	Jiangxi Zhenmei Biological Technology Co.,Ltd	c68795b8-bf68-0d01-e053-2a95a90abebb	2023-12-04	Warnings	Exact identifier unii: 059QF0KO0R
CVS Maximum Strength LIDOCAINE PLUS	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	CVS Pharmacy Inc.	e6aff579-affb-41bb-8e36-53ea484cb0c5	2023-11-26	Warnings	Exact identifier unii: LKG8494WBH
3b41da76-67b3-4921-ae37-d0be4c8ada4c			89afb1dc-a236-4154-b8b5-2cab6ad421c8	2023-11-24	Warnings	Exact identifier spl id: 3b41da76-67b3-4921-ae37-d0be4c8ada4c spl set id: 89afb1dc-a236-4154-b8b5-2cab6ad421c8
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	A-S Medication Solutions	6605103b-fd71-4438-8496-f48973b98901	2023-10-31	Warnings, Adverse reactions	Exact identifier unii: 012C11ZU6G
ANUBISMED	HA HYALURONIC	ANUBIS COSMETICS SL	eac771e2-4c1b-3808-e053-2995a90ac5fc	2023-09-05	Warnings	Exact identifier unii: 059QF0KO0R unii: 936JST6JCN
AnubisMed	SPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSION	ANUBIS COSMETICS SL	e99d92c4-8768-9c0a-e053-2a95a90a609e	2023-09-05	Warnings	Exact identifier unii: 059QF0KO0R
AnubisMed	AZELAIC ACID, SALICYLIC ACID	ANUBIS COSMETICS SL	ebf3153d-30f5-54e4-e053-2995a90a74b1	2023-09-05	Warnings	Exact identifier unii: 059QF0KO0R
AnubisMed	GLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACID	ANUBIS COSMETICS SL	eca95dde-cb57-2ab6-e053-2995a90af84f	2023-09-05	Warnings	Exact identifier unii: 059QF0KO0R
AnubisMed	SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA	ANUBIS COSMETICS SL	ebf4b3ab-34e1-185a-e053-2a95a90ace3a	2023-09-05	Warnings	Exact identifier unii: 059QF0KO0R
Lipotox	SQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,	BioActive Nutritional, Inc.	a1538692-ca00-4e52-9b7e-409767ee27e1	2023-09-05	Warnings	Exact identifier unii: LKG8494WBH unii: 2KR89I4H1Y
Anubis Barcelona	GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE	ANUBIS COSMETICS SL	eb651769-4d98-2b3b-e053-2a95a90a36b0	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona	DMAE	ANUBIS COSMETICS SL	f22b212d-d21d-5984-e053-2995a90a683e	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R unii: CAL22UVI4M
Anubis Barcelona	DMAE, ZIRHAFIRM	ANUBIS COSMETICS SL	f2274f8c-08aa-eb02-e053-2a95a90a3998	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R unii: LKG8494WBH
Anubis Barcelona	PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOIN	ANUBIS COSMETICS SL	eb9244ea-6102-3cbe-e053-2a95a90ab8f6	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Vital Line	HYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDES	ANUBIS COSMETICS SL	ebe024f7-7c45-ad60-e053-2995a90a45d6	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R unii: 936JST6JCN
Anubis Barcelona	PROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOL	ANUBIS COSMETICS SL	ebdddcec-f5da-51fe-e053-2995a90a6167	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Regul Oil	PROPYLENE GLYCOL, PANTHENOL, THIAMINE HCL	ANUBIS COSMETICS SL	eb8e5beb-4452-58c2-e053-2a95a90a66e0	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R
Anubis Barcelona Protective Line	ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE	ANUBIS COSMETICS SL	ec83846f-11c0-8f59-e053-2995a90ab9d2	2023-09-01	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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