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		2026-08-17

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…`

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 1 of 51 · 1,001 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WISH HAND SANITIZER Banana Cream Sugar	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	5912d7e8-94a7-e8b9-e063-6394a90a74d6	2026-08-15	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER Caramel Vanilla Popcorn	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	591317be-856e-1374-e063-6394a90a7aaf	2026-08-15	Warnings	Exact identifier application number: M005
BlissCare tea tree oil antifungal	TOLNAFTATE	Guangdong Aimu Biological Technology Co., Ltd	58f9ff8c-d75a-ad1d-e063-6294a90af3dc	2026-08-14	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER Rose Woods	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	58fb4491-2918-c486-e063-6394a90a621f	2026-08-14	Warnings	Exact identifier application number: M005
VXGXO antifungal with tea tree oil	TOLNAFTATE	Guangdong Aimu Biological Technology Co., Ltd	58fd67c5-c985-13a7-e063-6294a90a40fb	2026-08-14	Warnings	Exact identifier application number: M005
Charmpoo ANTIFUNGAL BODY Cream	MICONAZOLE NITRATE 2% ANTIFUNGAL BODY CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	58ff4779-83a7-afe2-e063-6294a90a9f9a	2026-08-14	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	YYBA CORP	58f1707a-579b-1e06-e063-6294a90a5a9f	2026-08-13	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER Mango Coconut Cream	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	58faa781-520b-92fa-e063-6294a90a9ecf	2026-08-13	Warnings	Exact identifier application number: M005
Gemachlich Zu Hause Vaginal Antifungal Gel	MICONAZOLE NITRATE	Guangzhou Xinhongda Trading Service Co., Ltd.	563cfb57-f10c-96a6-e063-6294a90a2b93	2026-08-12	Warnings	Exact identifier application number: M005
Hecila ANTIFUNGAL NAIL	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	58c117cc-e039-86f6-e063-6394a90af18f	2026-08-12	Warnings	Exact identifier application number: M005
TOTCLEAR NAIL RENEWAL	UNDECYLENIC ACID	GOOD BRIDGE LLC	93605e22-920d-43c3-bb2b-6e3116a19f5e	2026-08-12	Warnings	Exact identifier application number: M005
TOTCLEAR NAIL RENEWAL	UNDECYLENIC ACID	GOOD BRIDGE LLC	fde7d6ea-1b44-4a88-820a-0f2e033727e1	2026-08-11	Warnings	Exact identifier application number: M005
XBOFPEN MULTI-PURPOSE TREATMENT	TOLNAFTATE 1% MULTI-PURPOSE TREATMENT	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	58c2f50c-9c9e-4989-e063-6394a90abb21	2026-08-11	Warnings	Exact identifier application number: M005
QualiLife persimmon foot and shoe	UNDECYLENIC ACID	Guangdong Aimu Biological Technology Co., Ltd	584966c7-ceae-91af-e063-6294a90ac1eb	2026-08-10	Warnings	Exact identifier application number: M005
Aiilo WART REMOVER	SALICYLIC ACID 40%	Guangzhou Huixue Biotechnology Co., Ltd.	58ad9307-a9f9-4de8-e063-6394a90adaa6	2026-08-10	Warnings	Exact identifier application number: M005
Aiilo WART REMOVER PATCHES	SALICYLIC ACID 40%	Guangzhou Huixue Biotechnology Co., Ltd.	58af5ac2-75a7-246d-e063-6394a90ae966	2026-08-10	Warnings	Exact identifier application number: M005
Persiancat ANTIFUNGAL PEN	UNDECYLENIC ACID	Guangzhou ChuanMa International Trading Co.,Ltd.	58affb96-6cfc-b1fb-e063-6294a90a340c	2026-08-10	Warnings	Exact identifier application number: M005
Dryello Tolnaftate 1% Antifungal	TOLNAFTATE	ProPedix, Inc.	58b6820c-f601-5921-e063-6294a90aa5e9	2026-08-10	Warnings	Exact identifier application number: M005
Anti-fungal	ANTI-FUNGAL SOAP	Shenzhen Chaoxiji Technology Co.,Ltd.	586ce6bf-2915-8ae7-e063-6394a90ae9be	2026-08-06	Warnings	Exact identifier application number: M005
Anti-fungal	ANTI-FUNGAL SOAP	Shenzhen Chaoxiji Technology Co.,Ltd.	586d92cb-4944-0e7b-e063-6394a90a37a2	2026-08-06	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