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 40 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAND SANITIZER	ALCOHOL	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	88a14b15-09d6-45de-97b6-cddce7ca420b	2025-04-19	Warnings	Exact identifier application number: M005
ELLEN HAND SANITIZER	ETHYL ALCOHOL	PT. SUPER HOME PRODUCT INDONESIA	33077eab-e686-249d-e063-6394a90a1b6d	2025-04-18	Warnings	Exact identifier application number: M005
MEDI-FIRST First Aid Antiseptic	BENZALKONIUM CHLORIDE	Ultra Distributors Inc	b6efaca5-49d0-b000-e053-2995a90ab9aa	2025-04-07	Warnings	Exact identifier application number: M005
ANTIBACTERIAL HAND SANITIZER	ETHYL ALCOHOL	ASC Marketing Ltd.	b42ebe64-0cad-2d26-e053-2a95a90af3dd	2025-04-07	Warnings	Exact identifier application number: M005
Anti-Bacterial HAND SANITIZER	ETHYL ALCOHOL	DISNEY DESTINATIONS,LLC	ae739bda-edf3-634b-e053-2a95a90a7385	2025-04-07	Warnings	Exact identifier application number: M005
Hand Sanitizer	ETHYL ALCOHOL	Orazen Inc	aa846bb7-a64b-3358-e053-2995a90a9d09	2025-04-07	Warnings	Exact identifier application number: M005
Hand Sanitizer	ETHYL ALCOHOL	Orazen Inc	9ae42862-f730-9d67-e053-2a95a90af955	2025-04-07	Warnings	Exact identifier application number: M005
Hand Sanitizer	ETHYL ALCOHOL	Orazen Inc	7e8f4517-c996-8797-e053-2991aa0a4f58	2025-04-07	Warnings	Exact identifier application number: M005
Hand Sanitizer	ETHYL ALCOHOL	Raining Rose, Inc.	43ab2651-6e0a-3d48-e054-00144ff88e88	2025-04-07	Warnings	Exact identifier application number: M005
Folliculitis Treatment Cream	MICONAZOLE NITRATE	TAGRID LLC	32396be0-f74a-5483-e063-6294a90ab3ae	2025-04-07	Warnings	Exact identifier application number: M005
Antifungal Treatment Liquid 25 undeclylenic Acid	UNDECYLENIC ACID	SANSAR, LLC	2ae0f300-154e-44c8-bcc3-b5c334e661ac	2025-04-02	Warnings	Exact identifier application number: M005
BBlove ALCOHOL WIPES	BBLOVE ALCOHOL WIPES	Shenzhen Shierjie Biological Engineering Co., LTD	3126955d-8fd1-04f8-e063-6294a90a886f	2025-03-31	Warnings	Exact identifier application number: M005
Tagrid Jock Itch Miconazole Nitrate 2%	MICONAZOLE NITRATE	TAGRID LLC	31abdc68-5027-15e7-e063-6394a90ac4e6	2025-03-31	Warnings	Exact identifier application number: M005
Tea Tree Oil Foot Soak and Body Soak	ZINC UNDECYLENATE	SANSAR, LLC	c43816ac-2228-43ce-ba45-80cf3a7788f2	2025-03-28	Warnings	Exact identifier application number: M005
health beyond HAND SANITIZER	ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	e5746be7-e9dc-42a6-a3d0-b386427caec5	2025-03-27	Warnings	Exact identifier application number: M005
Tagrit Antifungal Treament Ketoconazole 1%	KETOCONAZOLE	TAGRID LLC	315a8832-c42f-c07a-e063-6394a90a8218	2025-03-27	Warnings	Exact identifier application number: M005
1236-CS Antifungal Powder (Talc Free)	1236-CCANTIFUNGAL POWDER(TALC FREE)	Dynarex Corporation	312ba573-4008-83e6-e063-6294a90a4a6d	2025-03-25	Warnings	Exact identifier application number: M005
Antifungal Medicated Bar	TOLNAFTATE	RoyceDerm LLC	31305ed2-a0a0-6d4c-e063-6294a90a6ba5	2025-03-25	Warnings	Exact identifier application number: M005
Forticept Antimicrobial Hydrogel Wound Dressing	BENZETHONIUM CHLORIDE, THYMOL	Lidan, Inc	cd5b7a72-1b87-434d-973e-071d2c8a438c	2025-03-25	Warnings	Exact identifier application number: M005
Forticept HP Antiseptic Wound Cleanser	BENZALKONIUM CHLORIDE, ALLANTOIN	Lidan, inc.	41bb46ee-edce-4e1b-bcfd-5c5729e1eb15	2025-03-25	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