Tolnaftate

Product NDC: 56104-242
11-digit product format: 561040242
Labeler code: 56104
Product ID: 56104-242_bdd663ef-b337-6268-e053-2995a90aa269
Type: HUMAN OTC DRUG
Nonproprietary name: Antifungal Liquid Maximum Strength
Dosage form: LIQUID
Route: TOPICAL
Labeler: Premier Brands of America, Inc.
Application: part333C
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-03-05
Marketing end: 0000-00-00
Substance: TOLNAFTATE
Active strength: 0 g/30mL
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	56104-242		D	Discontinued by firm		2026-10-12
excluded package	package	56104-242	56104-242-01	D	Discontinued by firm		2026-10-12

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 · 4 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	56104-242-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	56104-242-01	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
56104-242-01	2024-02-07	C162847	48780-1	f386c649-d689-0266-e053-dadaa90a7c1a	Premier Tolnaftate 1% Anti-Fungal
56104-242-01	2023-01-30	C162847	48780-1	f386c649-d689-0266-e053-dadaa90a7c1a	Premier Tolnaftate 1% Anti-Fungal

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
56104-242	TOLNAFTATE (ANTIFUNGAL LIQUID MAXIMUM STRENGTH) LIQUID [PREMIER BRANDS OF AMERICA, INC.]	5	Legacy NDC	20241222_bcbd52e4-696e-df39-e053-2a95a90a83f8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
06KB629TKV	TOLNAFTATE	2398-96-1	TOLNAFTATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
56104-242-01	56104024201	30 mL in 1 BOTTLE, WITH APPLICATOR (56104-242-01)	30 ml	2021-03-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Premier Tolnaftate 1% Anti-Fungal	Premier Brands of America, Inc.	2024-12-20	HUMAN OTC DRUG LABEL	5