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 19 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAND SANITIZER lsland Coconut	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	4bf3a822-27d2-efef-e063-6294a90a0502	2026-03-01	Warnings	Exact identifier application number: M005
HAND SANITIZER Cherry Blossom	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	4bf48a93-345d-b901-e063-6394a90ab41b	2026-03-01	Warnings	Exact identifier application number: M005
HAND SANITIZER Cucumber Melon	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	4bf552a4-b8b3-6fe3-e063-6394a90a722a	2026-03-01	Warnings	Exact identifier application number: M005
HAND SANITIZER Watermelon Sugar	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	4bf57b6e-c271-b4c6-e063-6394a90a63c6	2026-03-01	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	TRIFECTA PHARMACEUTICALS USA LLC	e0a2a907-9c3a-4c4e-e053-2995a90abb91	2026-03-01	Warnings	Exact identifier application number: M005
FOLUPIA FUNGAL NAIL RENEWAL	FOLUPIA FUNGAL NAIL RENEWAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4bcacd53-9446-67ec-e063-6294a90a209e	2026-02-27	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	d6f5c6b5-5e56-462f-8c47-7986ce53669d	2026-02-25	Warnings	Exact identifier application number: M005
Lakeim FUNGAL NAIL RENEWAL Kit	FUNGAL NAIL RENEWAL KIT	Guangzhou Jingliang Cosmetics Co., Ltd.	4b6aae50-b219-beee-e063-6394a90ab415	2026-02-22	Warnings	Exact identifier application number: M005
Hermon Jock Itch spray.	MICONAZOLE NITRATE 2%	Beautivity LLC	4b633528-667a-f34e-e063-6294a90a2b3d	2026-02-21	Warnings	Exact identifier application number: M005
Lakeim Fungal Nail Repair Pen	FUNGAL NAIL REPAIR PEN	Guangzhou Jingliang Cosmetics Co., Ltd.	4b23c3a6-51da-7875-e063-6394a90a1467	2026-02-18	Warnings	Exact identifier application number: M005
OSIMOON FUNGAL NAIL RENEWAL	FUNGAL NAIL RENEWAL	Guangzhou Jingliang Cosmetics Co., Ltd.	4b113f31-1a82-a3ca-e063-6394a90a3231	2026-02-17	Warnings	Exact identifier application number: M005
Hermon Ringworm Antifungal soap.	CLOTRIMAZOLE 1%	Beautivity LLC	48405a7c-14cd-b3a0-e063-6394a90a9fc9	2026-02-13	Warnings	Exact identifier application number: M005
RoyceDerm Tea Tree Oil Antifungal soap.	TEA TREE OIL ANTIFUNGAL SOAP	RoyceDerm LLC	3a6d1e32-a38b-3dde-e063-6394a90a88f3	2026-02-13	Warnings	Exact identifier application number: M005
Happy Nuts Jock Itch Powder	MICONAZOLE NITRATE	Suit Up Brands LLC	42e2d9df-6537-b3a1-e063-6394a90a47b7	2026-02-13	Warnings	Exact identifier application number: M005
Nail Antifungal Treatment	TOLNAFTATE 1% FUNGI NAIL	BENM INC.	2ea24785-c648-4104-e063-6294a90ab12f	2026-02-12	Warnings	Exact identifier application number: M005
Hermon Ringworm Treatment Kit	MICONAZOLE NITRATE 2% AND CLOTRIMAZOLE 1%	Beautivity LLC	4a9d9c6e-0e0f-d539-e063-6294a90acb57	2026-02-12	Warnings	Exact identifier application number: M005
PHARMBANNER Antifungal Soothing Cream	ANTIFUNGAL SOOTHING CREAM	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3a077685-4177-bc0d-e063-6294a90a461b	2026-02-12	Warnings	Exact identifier application number: M005
PHARMBANNER FUNGAL NAIL RENEWAL	FUNGAL NAIL RENEWAL	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3a08ec6c-03ae-b9e5-e063-6394a90a0afb	2026-02-12	Warnings	Exact identifier application number: M005
PHARMBANNER Tinea Versicolor Cream	TINEA VERSICOLOR CREAM	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3a095194-c7ea-7f30-e063-6294a90a7ea1	2026-02-12	Warnings	Exact identifier application number: M005
PHARMBANNER TINEA VERSICOLOR Cream	TINEA VERSICOLOR CREAM	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3db832f4-630d-72a2-e063-6394a90a08dc	2026-02-12	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