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 20 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolnafate	TOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREE	Chain Drug Consortium, LLC	5f9edcf9-b99e-65a2-e053-2a91aa0af565	2026-02-12	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE POWDER SPRAY	Chain Drug Consortium, LLC	5fafc16d-7257-fc88-e053-2991aa0a67c4	2026-02-12	Warnings	Exact identifier application number: M005
Kerova Miconazole Nitrate	MICONAZOLE NITRATE	Guangzhou Bixiaoyu Trading Co., Ltd.	3b8b5547-f8d1-9e48-e063-6294a90af429	2026-02-12	Warnings	Exact identifier application number: M005
natouch	MICONAZOLE	Natouch LLC	a980ff33-2b6d-3065-e053-2995a90ae974	2026-02-11	Warnings	Exact identifier application number: M005
Tuymec Antifungal Medicated Bar	ANTIFUNGAL MEDICATED BAR	Guangzhou Jingliang Cosmetics Co., Ltd.	4a8265c5-9c69-a36a-e063-6294a90ab292	2026-02-11	Warnings	Exact identifier application number: M005
Tuymec FUNGAL NAIL TREATMENT Kit	FUNGAL NAIL TREATMENT KIT	Guangzhou Jingliang Cosmetics Co., Ltd.	4a983b42-9723-7a3a-e063-6394a90ae7b2	2026-02-11	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT SPRAY	CVS Pharmacy	1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3c	2026-02-10	Warnings	Exact identifier application number: M005
Kerova ANTIFUNGAL	CLOTRIMAZOLE	Guangzhou Bixiaoyu Trading Co., Ltd.	4a7b48cf-72c3-be63-e063-6394a90a1efe	2026-02-10	Warnings	Exact identifier application number: M005
Kerova Clotrimazole	ANTIFUNGAL	Guangzhou Bixiaoyu Trading Co., Ltd.	4a7b9658-f411-299d-e063-6394a90af9ce	2026-02-10	Warnings	Exact identifier application number: M005
natouch	MICONAZOLE	Natouch LLC	3b1209fc-9d6b-2f55-e063-6394a90ac2ad	2026-02-10	Warnings	Exact identifier application number: M005
Nabrace Wipes for Ringworm, Jockitch and Athlete Feet	NABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEET	Nabrace LLC	0fdd1658-5759-8a42-e063-6394a90a7271	2026-02-10	Warnings	Exact identifier application number: M005
APUREE Nailtific Extra-Max Strength Antigungal	APUREE NAILTIFIC EXTRA-MAX STRENGTH ANTIGUNGAL	Guangzhou Meixi Biotechnology Co., Ltd.	4a633da8-dcba-349c-e063-6294a90a7702	2026-02-09	Warnings	Exact identifier application number: M005
Fungus Master Antifungal Treatment	MICONAZOLE NITRATE	Ebanel Laboratories, Inc	f7b011b2-11e5-46f1-afed-89f438985e00	2026-02-09	Warnings	Exact identifier application number: M005
OSIMOON Toenail Fungus Treatment	TOENAIL FUNGUS TREATMENT	Guangzhou Jingliang Cosmetics Co., Ltd.	4a7061a9-8ba2-72b8-e063-6294a90a4d9a	2026-02-09	Warnings	Exact identifier application number: M005
CLOTRIMAZOLE 1%	CLOTRIMAZOLE	PHARMACY CHOICE INC	43852cfb-6d28-e54f-e063-6394a90aa090	2026-02-08	Warnings	Exact identifier application number: M005
ASSIELF ANTIFUNGAL PEN	UNDECYLENIC ACID	Shenzhen Yuanbang International Logistics Co., Ltd	4a5d8e86-6401-7556-e063-6394a90acce1	2026-02-08	Warnings	Exact identifier application number: M005
Dryello Dual Action Relief for Athlete Foot	TOLNAFTATE	ProPedix, Inc.	359478dd-02c9-05e5-e063-6294a90a41ed	2026-02-06	Warnings	Exact identifier application number: M005
HEALMUSZ Clotrimazole	CLOTRIMAZOLE1% MICONAZOLE1% CLOTRIMAZOLE	Jiangxi Yudexi Pharmaceutical Co., LTD	4a326159-a6a7-c1d6-e063-6294a90a3b89	2026-02-06	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	Wal-Mart Stores, Inc.	17d0486e-e8b5-3afe-e063-6394a90aa384	2026-02-04	Warnings	Exact identifier application number: M005
Terramed Just Think Comfort Armor Antifungal Medicated	TOLNAFTATE	Rida LLC	33994035-b429-4ead-8885-98e38b25059a	2026-02-04	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