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 23 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MHB SKIN HYDRATING HAND SANITIZER, CITRUS PEEL	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	4868de4b-65ea-01ed-e063-6294a90ae551	2026-01-15	Warnings	Exact identifier application number: M005
Antifungal Ringworm Treatment	MICONAZOLE NITRATE	Rida LLC	eb953281-cf86-44cf-a3d1-37b8d344a6bc	2026-01-15	Warnings	Exact identifier application number: M005
ElixirTripleGuard Triple Antibiotic	MICONAZOLE NITRATE CREAM	ELIXIR HEALTHCARE USA, LLC.	0482ce9f-c98a-4f37-8b37-6df1738b6da3	2026-01-15	Warnings	Exact identifier application number: M005
MHB SKIN HYDRATING HAND SANITIZER SANTAL WAVE 35ml	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	483f3199-7357-112c-e063-6394a90aafa4	2026-01-14	Warnings	Exact identifier application number: M005
MHB SKIN HYDRATING HAND SANITIZER, MELON MUSE	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	48555528-bbbc-ccef-e063-6294a90a6609	2026-01-14	Warnings	Exact identifier application number: M005
HERMON ANTIFUNGAL BAR	TOLNAFTATE	Haikou Pucao Trading Co.,Ltd	2da7a20e-021e-2111-e063-6294a90ad441	2026-01-14	Warnings	Exact identifier application number: M005
MHB SKIN HYDRATING HAND SANITIZER, LILY MIST	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	4866d108-0bbb-12bf-e063-6394a90a338c	2026-01-14	Warnings	Exact identifier application number: M005
Hermon Ringworm Treatment Body Wash	TOLNAFTATE 1%	Beautivity LLC	48417be9-7cc0-e2f3-e063-6294a90aa2a2	2026-01-13	Warnings	Exact identifier application number: M005
Desenex	MICONAZOLE NITRATE	Crown Laboratories	09964187-12f1-bbe6-e063-6394a90acba0	2026-01-12	Warnings	Exact identifier application number: M005
Zeasorb Jock Itch	MICONAZOLE NITRATE	Crown Laboratories	09d088ef-aab3-5565-e063-6394a90af263	2026-01-12	Warnings	Exact identifier application number: M005
Zeasorb Athletes Foot	MICONAZOLE NITRATE	Crown Laboratories	09bb313e-90cb-5629-e063-6294a90ac268	2026-01-12	Warnings	Exact identifier application number: M005
Desenex Antifungal Foot Cream	MICONAZOLE NITRATE	Crown Laboratories, Inc.	311abb56-e176-0510-e063-6294a90a97f5	2026-01-12	Warnings	Exact identifier application number: M005
BZK Antiseptic Swab	BENZALKONIUM CHLORIDE	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	94043f4e-fe47-4b6f-8354-30697daaed81	2026-01-12	Warnings	Exact identifier application number: M005
miconazole nitrate	MICONAZOLE NITRATE	AvPAK	eaf016f6-b631-af00-e053-2a95a90adc7b	2026-01-09	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	The Podiatree Company	68a4e3f5-f84d-5650-e053-2a91aa0a171d	2026-01-08	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	The Podiatree Company	79234400-0766-792c-e053-2a91aa0a6e6d	2026-01-08	Warnings	Exact identifier application number: M005
Fortinia	CLOTRIMAZOLE 1%	The Podiatree Company	a003130b-77f7-4d42-8e7f-edd55176f013	2026-01-08	Warnings	Exact identifier application number: M005
Fortinia OF	CLOTRIMAZOLE 1%	The Podiatree Company	60cbd3aa-9ad7-24e4-e053-2a91aa0ab05f	2026-01-08	Warnings	Exact identifier application number: M005
Fortinia	CLOTRIMAZOLE	The Podiatree Company	60ba6f8a-8617-d4f6-e053-2991aa0a4a71	2026-01-08	Warnings	Exact identifier application number: M005
RoyceDerm Anti fungal RELIEF cream	SALICYLIC ACID 2%	RoyceDerm LLC	47ec6277-e40f-af82-e063-6294a90ac8c1	2026-01-08	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