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 12 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lasolex AL	MICONAZOLE NITRATE 2% ANTIFUNGAL	PureTek Corporation	534df9be-b47a-03a1-e063-6394a90a265a	2026-06-02	Warnings	Exact identifier application number: M005
Athletes Foot	MICONAZOLE NITRATE	Premier Brands of America Inc	52d0909a-f404-0af4-e063-6394a90a3d0c	2026-06-01	Warnings	Exact identifier application number: M005
Kopa Haiku Antifungal Cream	MICONAZOLE NITRATE 2%	Trovina Co. Ltd	431483f6-2386-9f5c-e063-6294a90af104	2026-06-01	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	Walgreens Company	3f8d45e1-54a2-a658-e063-6294a90a6cbb	2026-06-01	Warnings	Exact identifier application number: M005
Remedy Nails	UNDECYLENIC ACID	Adwill Labs Inc	4e87b76c-c430-466a-bc30-fe1785c7c660	2026-06-01	Warnings	Exact identifier application number: M005
Anytalk Nail Fungus Treatment 15ml (1% Tonailate)	TOLNAFTATE1%	Guangzhou Huixue Biotechnology Co., Ltd.	52f1f654-fba3-e90e-e063-6394a90a1df4	2026-05-29	Warnings	Exact identifier application number: M005
RoyceDerm Tea Tree Oil Antifungal .spray.	CLOTRIMAZOLE 1%	RoyceDerm LLC	52da8be4-467c-c011-e063-6294a90a166f	2026-05-28	Warnings	Exact identifier application number: M005
Terramed Just Think Comfort Jock Itch Antifungal Treatment	MICONAZOLE NITRATE	Rida LLC	2acb9027-8f20-4b77-9b45-17fe11622c7c	2026-05-27	Warnings	Exact identifier application number: M005
Quali Life ANTIFUNGAL TEA TREE	TOLNAFTATE	Guangdong Aimu Biological Technology Co., Ltd	52b3b0df-3f62-f9bc-e063-6394a90a52b3	2026-05-26	Warnings	Exact identifier application number: M005
ANTIFUNGAL PEN	UNDECYLENIC ACID	Guangzhou Mizi Biotechnology Co., Ltd.	52b51877-e04c-569e-e063-6394a90a2fc9	2026-05-26	Warnings	Exact identifier application number: M005
NAIL EXTRA STRENGTH REPAIR PEN	UNDECYLENIC ACID	Guangzhou Mizi Biotechnology Co., Ltd.	52b6208d-53e4-eaa0-e063-6394a90abe7a	2026-05-26	Warnings	Exact identifier application number: M005
Toenail Fungus Pen Preventative	UNDECYLENIC ACID	Guangzhou Mizi Biotechnology Co., Ltd.	52b6766f-948b-2602-e063-6294a90a03cf	2026-05-26	Warnings	Exact identifier application number: M005
KDMAN	TOLNAFTATE	Dongguan Youmi Trading Co., Ltd	52a4e836-2059-a49f-e063-6394a90a6556	2026-05-25	Warnings	Exact identifier application number: M005
PUTRIZEN	UNDECYLENIC ACID, TOLNAFTATE	Guangzhou Lianbiquan Biological Technology co., Ltd	52a58f24-2a11-4d34-e063-6394a90a2924	2026-05-25	Warnings	Exact identifier application number: M005
Eye CareSpray	EYELID CLEANSING SPRAY	Shenzhen Shierjie Biological Engineering Co., LTD	52aef5dd-ff33-cace-e063-6294a90a415a	2026-05-25	Warnings	Exact identifier application number: M005
Saviland PRO Extra Strength Toenail Renewal Patches	TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	5250003a-8d3a-818b-e063-6294a90aa659	2026-05-21	Warnings	Exact identifier application number: M005
Saviland SSPro X Series Extra Strength Toenail Renewal Patches	TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	52506297-44d7-b2a7-e063-6394a90a0a3c	2026-05-21	Warnings	Exact identifier application number: M005
SSPROTIP X Extra Strength Nail Renewal Patches	TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	52512e7e-5e28-4383-e063-6294a90a448a	2026-05-21	Warnings	Exact identifier application number: M005
Vrenmol Extra Strength Nail Renewal Patches	TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	52516861-e386-d0cb-e063-6394a90a17d0	2026-05-21	Warnings	Exact identifier application number: M005
SSPROTIP X Extra Strength Toenail Renewal Solution	TOLNAFTATE,UNDECYLENIC ACID	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	52519110-a3c9-21da-e063-6294a90abbce	2026-05-21	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