Kroger

Product NDC: 30142-080
Requested package NDC: 30142-080-01
11-digit product format: 301420080
Labeler code: 30142
Product ID: 30142-080_39fd935e-d3ca-dcb1-e063-6294a90af4e4
Type: HUMAN OTC DRUG
Nonproprietary name: Terbinafine Hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: Kroger Company
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 1.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A077511-001	TERBINAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL			2007-07-02	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 24 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 ndc (package): 30142-080-01 ndc (product): 30142-080 ndc11 (package): 30142008001
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
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

Additional Listing Data#

Finished product: Yes
Brand name base: Kroger
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992528	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
32e79416-5de4-4f06-9fff-f8c36a1ad5db	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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
30142-080-01	2020-08-05	C162847	48780-1	9d75b9d0-1288-f424-e053-dadaa90a57ce	Kroger ® Antifungal
30142-080-01	2020-01-31	C162847	48780-1	9d75b9d0-1288-f424-e053-dadaa90a57ce	Kroger ® Antifungal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
30142-080-01	Kroger Antifungal	15 g in 1 TUBE	CREAM	15		4
30142-080-01	Kroger Antifungal	1 in 1 CARTON	CREAM	1		4

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
30142-080	KROGER ANTIFUNGAL (TERBINAFINE HYDROCHLORIDE) CREAM [KROGER COMPANY]	3	Current NDC, Legacy NDC, 2 package rows	20200806_32e79416-5de4-4f06-9fff-f8c36a1ad5db.zip

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
992528	terbinafine HCl 1 % Topical Cream	PSN	32e79416-5de4-4f06-9fff-f8c36a1ad5db	4
992528	terbinafine hydrochloride 10 MG/ML Topical Cream	SCD	32e79416-5de4-4f06-9fff-f8c36a1ad5db	4
992528	terbinafine hydrochloride 1 % Topical Cream	SY	32e79416-5de4-4f06-9fff-f8c36a1ad5db	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
30142-080-01	30142008001	1 TUBE in 1 CARTON (30142-080-01) / 15 g in 1 TUBE	1 tube	2007-07-02	0000-00-00	No	No	Current