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 16 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EXTRA STRENGTH TOENAIIL RENEWAL PEN	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eea5ee7-0ef9-8d34-e063-6294a90af595	2026-04-07	Warnings	Exact identifier application number: M005
Extra Strength Toenail Renewal Pen	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eeb59d2-3891-2e45-e063-6294a90a4fcf	2026-04-07	Warnings	Exact identifier application number: M005
RoyceDerm Tinea ANTIFUNGAL .soap.	CLOTRIMAZOLE 1%	RoyceDerm LLC	4e889f2b-9ea1-b1a6-e063-6394a90a4654	2026-04-03	Warnings	Exact identifier application number: M005
Toenail Fungus Treatment Extra Strength Pen	TOLNAFTATE, UNDECYLENIC ACID	Lianjiang Shanlilai E-commerce Co., Ltd.	28fbcc50-a3ac-d6d1-e063-6294a90aa2b6	2026-04-02	Warnings	Exact identifier application number: M005
TOENAIL FUNGUS TREATMENT Liquid	TOLNAFTATE, UNDECYLENIC ACID	Lianjiang Shanlilai E-commerce Co., Ltd.	28fc7049-e367-42bf-e063-6394a90a6f06	2026-04-02	Warnings	Exact identifier application number: M005
Fungal Nail Patches	TOLNAFTATE, UNDECYLENIC ACID	Lianjiang Shanlilai E-commerce Co., Ltd.	299a63ad-f321-117c-e063-6394a90a3a22	2026-04-02	Warnings	Exact identifier application number: M005
Secura Antifungal Greaseless	MICONAZOLE NITRATE	Smith & Nephew Medical Ltd	9be600e4-76ec-4071-a8ec-a0b23155271d	2026-04-02	Warnings	Exact identifier application number: M005
FifthPulse Bacitracin Zinc	BACITRACIN ZINC	WeCare Products LLC	5c6b3ad8-c158-4cc0-b1ba-b829b5df1284	2026-04-02	Warnings	Exact identifier application number: M005
FifthPulse Miconazole Nitrate Antifungal	MICONAZOLE NITRATE	WeCare Products LLC	b70238eb-afcb-4e09-976f-973df249241c	2026-04-02	Warnings	Exact identifier application number: M005
ANTIFUNGAL PEN	UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE	Hanyang Qisheng (Shenzhen) Technology Co., Ltd.	4e85f338-ffd7-85b1-e063-6294a90a3c87	2026-04-02	Warnings	Exact identifier application number: M005
RoyceDerm Anti-Fungal Cream	MICONAZOLE NITRATE 2%	RoyceDerm LLC	4e861073-88e8-b2f7-e063-6394a90ab94a	2026-04-02	Warnings	Exact identifier application number: M005
Miconazole Nitrate	JOCK ITCH SPRAY	CVS Pharmacy	7b70d3ea-126a-42aa-8509-b982893c710b	2026-04-01	Warnings	Exact identifier application number: M005
Fungicure Anti-Fungal Liquid	TOLNAFTATE	Kobayashi Healthcare International, Inc.	b18ee199-0659-733c-e053-2a95a90ab6b5	2026-04-01	Warnings	Exact identifier application number: M005
Tolnaftate	ANTIFUNGAL LIQUID SPRAY	CVS Pharmacy	96cc594d-85c8-4f62-bc0a-3176c8739f21	2026-04-01	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE POWDER SPRAY	CVS Pharmacy	a7b6bd7c-23db-43e1-92f7-e27f5f4801de	2026-04-01	Warnings	Exact identifier application number: M005
Baza Antifungal	MICONAZOLE NITRATE	Coloplast Corp	75182cb7-840a-423a-9c20-10840d6e1d65	2026-03-31	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Trifecta Pharmaceuticals Usa Llc	80217dbb-a0f0-414a-8d22-a9a346b017aa	2026-03-31	Warnings	Exact identifier application number: M005
RoyceDerm Antifungal Bar	CLOTRIMAZOLE	RoyceDerm LLC	3abdc4a8-58dd-5bd0-e063-6294a90a1bca	2026-03-31	Warnings	Exact identifier application number: M005
Critic Aid Clear AF	MICONAZOLE NITRATE	Coloplast Corp	cbc5d976-850a-476e-b179-b7a5a8675524	2026-03-31	Warnings	Exact identifier application number: M005
Velloryn ANTIFUNGAL Cream	ZINC UNDECYLENATE, UNDECYLENIC ACID	Guangdong Quadrant Ecological Technology Co., Ltd.	4e38e1f1-0466-5b91-e063-6294a90a66c4	2026-03-30	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