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		2026-10-21

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 25 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	CLOTRIMAZOLE	RUGBY LABORATORIES	6de9155b-7070-38fd-e053-2a91aa0af6f6	2025-12-19	Warnings	Exact identifier application number: M005
HC Max Anti-Fungal	TOLNAFTATE	Kramer Laboratories	ee99cd87-549f-4a43-878e-b4d5935de0e0	2025-12-19	Warnings	Exact identifier application number: M005
Fungi Nail Anti-Fungal Pen	TOLNAFTATE	Kramer Laboratories	1a0a3b14-d8f2-4363-b3c9-f5028e8eada3	2025-12-19	Warnings	Exact identifier application number: M005
Tolnaftate	FOOT ODOR CONTROL POWDER SPRAY	Winco Foods, LLC	cc257a18-247f-c787-e053-2a95a90a075a	2025-12-16	Warnings	Exact identifier application number: M005
Tobcharm Toenail Fungus Treatment Liquid	TOENAIL FUNGUS TREATMENT LIQUID	Guangzhou Qiexiran Cosmetics Co., Ltd.	45f92be2-0677-5989-e063-6394a90af280	2025-12-15	Warnings	Exact identifier application number: M005
TEA TREE Oil ANTIFUNGAL Cream	ZINC UNDECYLENATE, UNDECYLENIC ACID	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	45bd3ad0-a0d1-314f-e063-6394a90a9a3a	2025-12-12	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	Topco Associates LLC	97334166-1dff-4ed2-ad31-f524b22097f9	2025-12-12	Warnings	Exact identifier application number: M005
Foot Odor Control Powder	TOLNAFTATE	Meijer Distribution Inc	03fd2680-0040-aa8c-e063-6294a90a090f	2025-12-12	Warnings	Exact identifier application number: M005
Foot Odor Control Powder	TOLNAFTATE	Premier Brands of America Inc.	edb0a2da-aaa1-3b9b-e053-2995a90a5012	2025-12-12	Warnings	Exact identifier application number: M005
Pedikleer	TOLNAFTATE	Rising Pharma Holdings, Inc.	83396c51-7107-4d98-9d80-ebf6584f4dc8	2025-12-11	Warnings	Exact identifier application number: M005
ELAIMEI FUNGAL NAIL PATCHES	TEA TREE OIL	Shenzhen Shandian Jingling Technology Co., Ltd.	457d08eb-e812-8f12-e063-6294a90ab85f	2025-12-10	Warnings	Exact identifier application number: M005
Lofuanna FUNGAL NAIL PATCHES	TEA TREE OIL	Shenzhen Shandian Jingling Technology Co., Ltd.	43da9ec2-5f2f-dfce-e063-6394a90aecca	2025-12-10	Warnings	Exact identifier application number: M005
WRFAATGO ANTIFUNGAL Pen Undecylenic Acid 25%	UNDECYLENIC ACID 25%	Shenzhen Shandian Jingling Technology Co., Ltd.	457f819b-0850-a97c-e063-6394a90ac368	2025-12-09	Warnings	Exact identifier application number: M005
NAIL REPAIR PEN	UNDECYLENIC ACID	Yunqi Cosmetics (Shenzhen) Co., Ltd	45814b84-0e51-6c9d-e063-6394a90a2905	2025-12-09	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE ANTIFUNGAL POWDER SPRAY	Better Living Brands	ccfef81b-f271-4551-e053-2a95a90a8ac4	2025-12-09	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTI-FUNGAL MICONAZOLE ATHLETES FOOT SPRAY TALC FREE	Foodhold USA	a64c9371-0ac7-4c47-bc12-7bc77162b244	2025-12-09	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	Harris Teeter, LLC	02eb9c78-5a89-4958-b5a4-68f39e584cf2	2025-12-09	Warnings	Exact identifier application number: M005
Bee Venom Toenail Fungus Treatment	BEE VENOM TOENAIL FUNGUS TREATMENT	Shenzhen Earth Surface Trading Co., Ltd.	457c705a-9c49-c8c5-e063-6394a90a6aa3	2025-12-08	Warnings	Exact identifier application number: M005
Tolnaftate Antifungal Powder	TOLNAFTATE	SCHOLL'S WELLNESS COMPANY LLC	2a0e006b-60b1-41b9-a5d2-ff0e34b48ff5	2025-12-06	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	1e7e74f6-9bca-48ab-804a-a7a81df3b608	2025-12-05	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