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 17 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
APUREE Nailtific Extra-Max Strength Daytime Antigungal	APUREE NAILTIFIC EXTRA-MAX STRENGTH DAYTIME ANTIGUNGAL	Guangzhou Meixi Biotechnology Co., Ltd.	4e3d226b-57f1-75a6-e063-6394a90a96cd	2026-03-30	Warnings	Exact identifier application number: M005
APUREE Nailtific Extra-Max Strength Nighttime Antifungal	APUREE NAILTIFIC EXTRA-MAX STRENGTH NIGHTTIME ANTIFUNGAL	Guangzhou Meixi Biotechnology Co., Ltd.	4e3e8895-34b4-de69-e063-6294a90a5532	2026-03-30		Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	CVS Pharmacy	3380263d-ee7b-4946-a467-35a24789a901	2026-03-27	Warnings	Exact identifier application number: M005
Micro-Guard (AF)	MICONAZOLE NITRATE	Coloplast Corp	a43a94d0-fec0-470f-bdb4-535dcce6d1e0	2026-03-27	Warnings	Exact identifier application number: M005
Suave Antibacterial Hand Wash Fresh Citrus	LIQUID HAND WASH ANTIBACTERIAL	Suave Brands Co, LLC	41d77ec6-a1d1-13dc-e063-6394a90a95f4	2026-03-26	Warnings	Exact identifier application number: M005
Suave Antibacterial Hand Wash Deeply Clean	LIQUID HAND WASH ANTIBACTERIAL	Suave Brands Co, LLC	41d83736-66da-abb9-e063-6294a90a3d67	2026-03-26	Warnings	Exact identifier application number: M005
Suave Antibacterial Hand Wash Sea Minerals and Aloe Vera	LIQUID HAND WASH ANTIBACTERIAL	Suave Brands Co, LLC	41d8848c-d157-6e2c-e063-6294a90aa259	2026-03-26	Warnings	Exact identifier application number: M005
Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock Itch	ANTIFUNGAL TREATMENT KIT	Beautivity LLC	4800a93b-7042-827b-e063-6294a90acd95	2026-03-25	Warnings	Exact identifier application number: M005
Toenail Fungus Treatment	TERBINAFINE	Shenzhen Wankelai E-commerce Co., Ltd.	4dc1d7f7-e4ae-c54b-e063-6394a90aa420	2026-03-24	Warnings	Exact identifier application number: M005
Lasolex Liquid Solution	CLOTRIMAZOLE 1%	PureTek Corporation	4dc9e64d-8235-b218-e063-6394a90a0157	2026-03-24	Warnings	Exact identifier application number: M005
Hermon Jock Itch Antifungal Treatment .Soap. Bar	TOLNAFTATE 1%	Beautivity LLC	4dbbf09b-5bc1-501b-e063-6394a90a2a9d	2026-03-23	Warnings	Exact identifier application number: M005
Hermon Jock Itch Antifungal Treatment Cream	MICONAZOLE NITRATE 2%	Beautivity LLC	4dbc521c-2f5f-9736-e063-6294a90ad85d	2026-03-23	Warnings	Exact identifier application number: M005
seebeellar clotrimazole 1% antifungal cream	SEEBEELLAR CLOTRIMAZOLE 1% ANTIFUNGAL CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	4d80e551-76c2-150a-e063-6394a90a7996	2026-03-20	Warnings	Exact identifier application number: M005
Nail Fungal Pen	UNDECYLENIC ACID	Guangzhou Hechuang Commercial Service Co.,Ltd.	4d5b5c22-4781-6391-e063-6294a90a7010	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER MADRID MUSE	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d5cecf6-c232-6cd9-e063-6394a90a03e9	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER VALENCIA VIBES	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d5de4d6-4c58-f393-e063-6294a90a323a	2026-03-19	Warnings	Exact identifier application number: M005
Toenail Fungus Pen	UNDECYLENIC ACID	Guangzhou Hechuang Commercial Service Co.,Ltd.	4d5e256f-7fd5-f903-e063-6394a90a1160	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER MALLORCA BREEZE	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d5e50de-62fd-f9e9-e063-6394a90af0bd	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER MAR BELLA	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d6005d9-5d4d-033e-e063-6294a90ad36f	2026-03-19	Warnings	Exact identifier application number: M005
Triple Antifungal	MICONAZOLE NITRATE	Advantice Health, LLC	9a47fb1b-a41f-4c8a-8e43-7332853c308e	2026-03-19	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