Tolnaftate

Product NDC: 56104-001
11-digit product format: 561040001
Labeler code: 56104
Product ID: 56104-001_42785459-fa13-f7a0-e063-6394a90aaac4
Type: HUMAN OTC DRUG
Nonproprietary name: Antifungal Liquid Spray
Dosage form: AEROSOL, SPRAY
Route: TOPICAL
Labeler: Premier Brands of America Inc.
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-01-01
Substance: TOLNAFTATE
Active strength: 1.5 g/150g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	56104-001	56104-001-02	D	Discontinued by firm		2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 23 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	56104-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	56104-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	56104-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	56104-001-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	56104-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	56104-001-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	56104-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	56104-001-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	56104-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	56104-001-53	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	56104-001-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	56104-001-53	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	56104-001-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	56104-001-53	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	56104-001-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	56104-001-53	`0efc9e666f02…`	`f202fb6c5f17…`

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: Tolnaftate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOLNAFTATE	1.5 g/150g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
06KB629TKV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313421	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
7a6a63cd-e87d-4229-8acf-b65d63909eb6	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
56104-001-02	Tolnaftate	150 g in 1 CANISTER	AEROSOL, SPRAY	150		11
56104-001-53	Tolnaftate	150 g in 1 CANISTER	AEROSOL, SPRAY	150		11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	TOLNAFTATE (ANTIFUNGAL LIQUID SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]	1
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	TOLNAFTATE (ANTIFUNGAL LIQUID SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	TOLNAFTATE (ANTIFUNGAL LIQUID SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	TOLNAFTATE (ANTIFUNGAL LIQUID SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]	1
ISOBUTANE	INACTIVE INGREDIENT	BXR49TP611	TOLNAFTATE (ANTIFUNGAL LIQUID SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]	1
PPG-12-BUTETH-16	INACTIVE INGREDIENT	58CG7042J1	TOLNAFTATE (ANTIFUNGAL LIQUID SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA 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 31 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolnafate	TOLNAFTATE POWDER SPRAY	Better Living Brands LLC	ccff8d63-ee7d-eada-e053-2995a90ac5dd	2025-10-24	Warnings	Exact identifier application number: M005
Tolnaftate	ANTIFUNGAL LIQUID SPRAY	Better Living Brands LLC	ccff4830-6d81-2a0d-e053-2a95a90a154c	2025-10-24	Warnings	Exact identifier application number: M005
Liquid Antifungal Treatment	TOLNAFTATE	Hudson Health LLC	14a9efd8-e49f-12fa-e063-6394a90aa8a0	2025-10-24	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE	Hudson Health LLC	36ec5f05-5d1c-25df-e063-6394a90a9dd9	2025-10-24	Warnings	Exact identifier application number: M005
Signature Care Antifungal Cream Tolnaftate 1%	TOLNAFTATE	BETTER LIVING BRANDS LLC	b02b81d6-8db4-927b-e053-2995a90a3958	2025-10-24	Warnings	Exact identifier application number: M005
Winco Foods Tolnaftate	TOLNAFTATE	Winco Foods, LLC	218f7613-1401-4f1b-bf46-576b536825af	2025-10-23	Warnings	Exact identifier application number: M005
zourunan MULTI-PURPOS TREATMENT	MULTI-PURPOS TREATMENT	Guchutang Biotechnology (Longyan) Co., Ltd	41bad254-b674-9521-e063-6294a90ab634	2025-10-22	Warnings	Exact identifier application number: M005
zourunan FOOT ODOR PROBIOTIC	FOOT ODOR	Guchutang Biotechnology (Longyan) Co., Ltd	41bbc02c-53f2-2d94-e063-6394a90ac9ec	2025-10-22	Warnings	Exact identifier application number: M005
Signature Care Athletes Foot	CLOTRIMAZOLE	Safeway	c1750c17-4afb-aecf-e053-2a95a90af35b	2025-10-22	Warnings	Exact identifier application number: M005
Athletes Foot	TOLNAFTATE	Imperial Feet B.V.	1189c7d8-7c8f-ae01-e063-6294a90ac270	2025-10-21	Warnings	Exact identifier application number: M005
Fungicure Liquid Gel	CLOTRIMAZOLE	Kobayashi Healthcare International, Inc.	dfd03852-29bd-4e16-97f3-64dfde5f8ff8	2025-10-21	Warnings	Exact identifier application number: M005
Athlete Foot Medicated bar	TOLNAFTATE	Beautivity LLC	3b2cedb2-18f4-f571-e063-6394a90a6418	2025-10-21	Warnings	Exact identifier application number: M005
Athletes Foot	TOLNAFTATE	Quantum, Inc.	6cb95707-9831-41f1-a23e-9e3356141fdc	2025-10-20	Warnings	Exact identifier application number: M005
Toe Fungus	TOLNAFTATE	Imperial Feet B.V.	118a6c97-4e8a-050a-e063-6294a90a1108	2025-10-17	Warnings	Exact identifier application number: M005
Inlifay ANTIFUNGAL	TOLNAFTATE	Guangzhou Haishi Biological Technology Co., Ltd.	4141574d-7a5b-c437-e063-6394a90aacb6	2025-10-16	Warnings	Exact identifier application number: M005
Tolnaftate	ANTIFUNGAL LIQUID SPRAY	HY-VEE, INC	415ecf9b-460d-82b6-e063-6294a90a0e05	2025-10-16	Warnings	Exact identifier application number: M005
SEACALL NAIL REVIVE SERUM	NAIL REVIVE SERUM	Guangdong Quadrant Ecological Technology Co., Ltd.	1f4d0c9a-361e-72e5-e063-6394a90a7cda	2025-10-15	Warnings	Exact identifier application number: M005
Arflom Toenail Fungus Treatment Liquid	TOENAIL FUNGUS TREATMENT LIQUID	Guangzhou Qiexiran Cosmetics Co., Ltd.	413e76b5-263c-62fa-e063-6294a90a9214	2025-10-15	Warnings	Exact identifier application number: M005
VTROUY Fungus Nail Renewal	FUNGUS NAIL RENEWAL	Guangzhou Qiexiran Cosmetics Co., Ltd.	413f6399-dda1-8dd9-e063-6394a90a573d	2025-10-15	Warnings	Exact identifier application number: M005
Hongo Killer	UNDECYLENIC ACID	Efficient Laboratories Inc	f647308a-ea6c-47a9-a124-60e7888afac2	2025-10-14	Warnings	Exact identifier application number: M005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
06KB629TKV	TOLNAFTATE	2398-96-1	TOLNAFTATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313421	tolnaftate 1 % Topical Spray	PSN	7a6a63cd-e87d-4229-8acf-b65d63909eb6	11
313421	tolnaftate 10 MG/ML Topical Spray	SCD	7a6a63cd-e87d-4229-8acf-b65d63909eb6	11
313421	tolnaftate 1 % Topical Spray	SY	7a6a63cd-e87d-4229-8acf-b65d63909eb6	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
56104-001-02	56104000102	150 g in 1 CANISTER (56104-001-02)	150 g	2013-01-01	0000-00-00	No	No	Current
56104-001-53	56104000153	150 g in 1 CANISTER (56104-001-53)	150 g	2013-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Premier Brands Tolnaftate Liquid Spray	Premier Brands of America Inc.	2025-10-31	HUMAN OTC DRUG LABEL	11