Silka

Product NDC: 50066-080
Requested package NDC: 50066-080-02
11-digit product format: 500660080
Labeler code: 50066
Product ID: 50066-080_38f62b9e-4081-44e8-e063-6394a90a1f3a
Type: HUMAN OTC DRUG
Nonproprietary name: Terbinafine Hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: Genomma Lab USA, Inc.
Application: ANDA077511
Marketing category: ANDA
Marketing start: 2007-07-02
Substance: TERBINAFINE HYDROCHLORIDE
Active strength: 1 g/100g
Pharmacologic classes: Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077511-001	TERBINAFINE HYDROCHLORIDE	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL			2007-07-02

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL	2007-07-02	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Silka
Brand name suffix: Antifungal
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TERBINAFINE HYDROCHLORIDE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
012C11ZU6G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992528	Internal RxNorm lookup
1739221	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a32cf699-e63e-4bd3-a5af-9e1ba447e02e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
55a24767-1759-5f6a-8888-ea4aa0adac21	Product name	1	20140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50066-080-02	Silka Antifungal	30 g in 1 TUBE	CREAM	30	7
50066-080-02	Silka Antifungal	1 in 1 CARTON	CREAM	1	7
50066-080-03	Silka Antifungal	30 g in 1 TUBE	CREAM	30	7
50066-080-03	Silka Antifungal	1 in 1 CARTON	CREAM	1	7
50066-080-05	Silka Antifungal	15 g in 1 TUBE	CREAM	15	7
50066-080-05	Silka Antifungal	1 in 1 CARTON	CREAM	1	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Terbinafine Hydrochloride	ACTIVE INGREDIENT	012C11ZU6G	SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]	1
Terbinafine	ACTIVE MOIETY	G7RIW8S0XP	SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]	1
cetyl palmitate	INACTIVE INGREDIENT	5ZA2S6B08X	SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]	1
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50066-080	SILKA ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [GENOMMA LAB USA, INC.]	6	Current NDC, Legacy NDC, 6 package rows	20240412_a32cf699-e63e-4bd3-a5af-9e1ba447e02e.zip

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 1 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Scholl's Wellness Company LLC	31f59302-eaee-211b-e063-6294a90a08b0	2026-04-03	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	92b31fc4-0f02-4857-b11f-49b9f942ee84	2026-02-20	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
Walgreens Athletes Foot	TERBINAFINE HYDROCHLORIDE	Walgreen Company	d706c56f-0123-4a5a-8c85-240cbe6ef7a5	2025-11-26	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
CVS	TERBINAFINE HYDROCHLORIDE	CVS Pharmacy	17684ba2-3c2c-4259-84fa-3833f19e5a4d	2025-11-25	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
Good Neighbor Pharmacy	TERBINAFINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	0a9e890c-1eed-4fde-a484-852a4dd135c2	2025-10-17	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc	6016e546-6c02-4af0-888c-c0899865c5f0	2025-09-30	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
CVS Pharmacy Athletes Foot	TERBINAFINE HYDROCHLORIDE	CVS Pharmacy	98a4ed66-2813-49de-8cda-94c41cc3ca9f	2025-09-25	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
Athletes Foot	TERBINAFINE HYDROCHLORIDE	Publix Super Markets Inc.	58293d62-089d-49ab-b691-dfd705ac9a9c	2025-09-25	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
equate Athletes Foot	TERBINAFINE HYDROCHLORIDE	Wal-Mart Stores Inc	e799c808-7c0f-482d-99d2-35fc34dbb2ea	2025-08-14	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
Good Neighbor Pharmacy	TERBINAFINE HYDROCHLORIDE	AmerisourceBergen	93ea9e7f-6914-4df2-8ca0-27c453806623	2025-07-28	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
Athletes Foot	TERBINAFINE HYDROCHLORIDE	Rite Aid Corporation	a7b0a70b-a117-48cf-a6bc-260be1dac1e7	2025-07-28	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	28a3ece3-78fb-4121-86a7-adc4a9d9540f	2025-07-21	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
Athletes Foot	TERBINAFINE HYDROCHLORIDE	H E B	28db9a27-4d23-48ef-b1f3-08b993948c11	2025-07-15	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
Kroger Antifungal	TERBINAFINE HYDROCHLORIDE	Kroger Company	32e79416-5de4-4f06-9fff-f8c36a1ad5db	2025-07-15	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	WALGREEN COMPANY	2ba1924b-9967-4adb-9061-d023ef44ab3e	2025-07-10	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Cardinal Health, 110 dba LEADER	a9412747-c7f9-4242-91ed-3695f372f6c9	2025-07-09	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
Silka Antifungal	TERBINAFINE HYDROCHLORIDE	Genomma Lab USA, Inc.	a32cf699-e63e-4bd3-a5af-9e1ba447e02e	2025-07-02	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511 ndc (package): 50066-080-02 ndc (product): 50066-080 ndc11 (package): 50066008002
Silka Jock Itch	TERBINAFINE HYDROCHLORIDE	Genomma Lab USA, Inc.	326d8586-042f-44f8-8530-e46b7b777bc3	2025-07-02	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
Antifungal	TERBINAFINE HYDROCHLORIDE	Meijer Distribution Inc	9daf3136-74b6-4410-8256-cbc9dd700f61	2025-07-02	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511
Terbinafine Hydrochloride	TERBINAFINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ca9cd2bd-4805-4469-b754-01a7487b71a6	2025-07-01	Warnings	Exact identifier application applno (ANDA): 077511 application number: ANDA077511

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
012C11ZU6G	TERBINAFINE HYDROCHLORIDE	78628-80-5	TERBINAFINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1739221	SILKA 1 % Topical Cream	PSN	a32cf699-e63e-4bd3-a5af-9e1ba447e02e	7
992528	terbinafine HCl 1 % Topical Cream	PSN	a32cf699-e63e-4bd3-a5af-9e1ba447e02e	7
1739221	terbinafine hydrochloride 10 MG/ML Topical Cream [Silka Cream]	SBD	a32cf699-e63e-4bd3-a5af-9e1ba447e02e	7
992528	terbinafine hydrochloride 10 MG/ML Topical Cream	SCD	a32cf699-e63e-4bd3-a5af-9e1ba447e02e	7
1739221	Silka 1 % Topical Cream	SY	a32cf699-e63e-4bd3-a5af-9e1ba447e02e	7
1739221	Silka Cream 10 MG/ML Topical Cream	SY	a32cf699-e63e-4bd3-a5af-9e1ba447e02e	7
992528	terbinafine hydrochloride 1 % Topical Cream	SY	a32cf699-e63e-4bd3-a5af-9e1ba447e02e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50066-080-02	50066008002	1 TUBE in 1 CARTON (50066-080-02) / 30 g in 1 TUBE	1 tube	2007-07-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Silka ® Antifungal	Genomma Lab USA, Inc. \| Sun Pharma Canada Inc.	2025-07-02	HUMAN OTC DRUG LABEL	7