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 47 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ER Hand Sanitizer Packets	ALCOHOL	EVER READY FIRST AID	d0b6d09c-26e0-45c7-8d37-7d42143b2e31	2024-01-11	Warnings	Exact identifier application number: M005
clotrimazole	CLOTRIMAZOLE	Proficient Rx LP	eeb241a3-93ee-4b74-8cbb-65713d15e7e0	2024-01-01	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Proficient Rx LP	ba1dc4a4-073f-4f30-bb9c-9ed043700431	2024-01-01	Warnings	Exact identifier application number: M005
RUGBY ANTIFUNGAL CLOTRIMAZOLE	CLOTRIMAZOLE	Proficient Rx LP	7c64553b-589c-4e65-a6f0-b2847bbbe8a6	2024-01-01	Warnings	Exact identifier application number: M005
Dr. Scholls Instant Cool Athletes foot treatment with Menthol	TOLNAFTATE	Scholl's Wellness Company	dad00745-e411-35b8-e053-2a95a90a1000	2023-12-21	Warnings	Exact identifier application number: M005
TINEACIDE	TOLNAFTATE	Blaine Labs Inc.	273eb424-5dc3-40c8-9ea7-2f732cbd11c9	2023-12-21	Warnings	Exact identifier application number: M005
TERPENICOL ANTIFUNGAL	UNDECYLENIC ACID	Blaine Labs Inc.	a020334e-aac9-4ea5-a0ea-8e5b021fe2eb	2023-12-21	Warnings	Exact identifier application number: M005
TERPENICOL	UNDECYLENIC ACID	Blaine Labs Inc.	efd99ed1-07d3-4862-ae47-883f7d1c91c6	2023-12-21	Warnings	Exact identifier application number: M005
sunmark antifungal	TOLNAFTATE	A-S Medication Solutions	6f85fbb0-297c-4949-83f2-ed9a52172154	2023-12-16	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	7a0ef38a-9584-4e67-ba86-c31f86da1ed0	2023-12-11	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	7d284f6f-a970-49fe-b45a-d5c6c2688bc2	2023-12-11	Warnings	Exact identifier application number: M005
Hi Vetic	TOLNAFTATE	Sato Pharmaceutical Co., Ltd.	2096e241-3ed3-49cd-88c4-71db1fd2934a	2023-12-06	Warnings	Exact identifier application number: M005
Undecylenic Acid	UNDECYLENIC ACID	Chemco Corporation	7391b53f-5567-1f45-e053-2991aa0a4fce	2023-12-05	Warnings	Exact identifier application number: M005
Hi Vetic	TOLNAFTATE	Sato Pharmaceutical Co., Ltd.	be92b480-56e8-4371-adbc-40fe74f6747c	2023-12-01	Warnings	Exact identifier application number: M005
Antifungal Cream	ANTIFUNGAL	BluePoint Laboratories	b4c4240f-f84c-ec5e-e053-2a95a90aa082	2023-11-17	Warnings	Exact identifier application number: M005
Antifungal Cream	ANTIFUNGAL	BluePoint Laboratories	b564f971-2a9b-a605-e053-2995a90aee69	2023-11-17	Warnings	Exact identifier application number: M005
EVERLIT CARE Hand Sanitizer	ETHYL ALCOHOL	EVERLIT GLOBAL INC.	b9909c59-02e7-4d6c-aa2b-206f1ab4d02c	2023-11-14	Warnings	Exact identifier application number: M005
FLUSH Maximum Strength Antifungal formula	UNDECYLENIC ACID	Triple Point Group, LLC	1d9e56ef-c7c9-4aff-ab9e-b163e566e3d5	2023-11-11	Warnings	Exact identifier application number: M005
SIMPLY VITAL Antifungal Cream	CLOTRIMAZOLE	ALPHA PLANTS INC	d3842de3-0d13-4dc2-920b-90a4b822bbb8	2023-11-11	Warnings	Exact identifier application number: M005
CLARUS AC Antifungal Solution	TOLNAFTATE	Clinical Therapeutic Solutions	28ab9f1b-65cd-4405-a9a3-f3c9b836693d	2023-11-10	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