TINEACIDE

Product NDC: 63347-511
11-digit product format: 633470511
Labeler code: 63347
Product ID: 63347-511_7929e269-caee-4126-a9ba-14cbc2dd73d1
Type: HUMAN OTC DRUG
Nonproprietary name: TOLNAFTATE
Dosage form: LIQUID
Route: TOPICAL
Labeler: Blaine Labs Inc.
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-09-19
Substance: TOLNAFTATE
Active strength: 140 mg/15mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63347-511		D	Discontinued by firm		2026-10-12
excluded package	package	63347-511	63347-511-01	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 · 24 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	63347-511-01	`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	63347-511-01	`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	63347-511-01	`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	63347-511-01	`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	63347-511-01	`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	63347-511-01	`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	63347-511-01	`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	63347-511-01	`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	63347-511-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63347-511-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63347-511-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63347-511-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: TINEACIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOLNAFTATE	140 mg/15mL

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
273eb424-5dc3-40c8-9ea7-2f732cbd11c9	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63347-511-03	2022-02-21	C162847	48780-1	d6a99b39-66fc-a426-e053-dadaa90af4c2	273eb424-5dc3-40c8-9ea7-2f732cbd11c9
63347-511-03	2022-01-28	C162847	48780-1	d6a99b39-66fc-a426-e053-dadaa90af4c2	273eb424-5dc3-40c8-9ea7-2f732cbd11c9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63347-511-03	TINEACIDE	15 mL in 1 BOTTLE	LIQUID	15		9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	4
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	4
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	4
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	4
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	4
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	4
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	4
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	4
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	4
OREGANO LEAF OIL	INACTIVE INGREDIENT	7D0CGR40U1	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	4
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	4
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63347-511	TINEACIDE (TOLNAFTATE) LIQUID [BLAINE LABS INC.]	9	Current NDC, Legacy NDC, 1 package rows	20231222_273eb424-5dc3-40c8-9ea7-2f732cbd11c9.zip

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 27 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Myco Nail A Antifungal Solution	UNDECYLENIC ACID	Kramer Novis	550358d7-69e8-4ea3-bcf9-d647c457287d	2025-12-04	Warnings	Exact identifier application number: M005
Tea Tree Oil Antifungal Soaps	TOLNAFTATE	Nanjing Jitaxing Technology Co., LTD	4517d3a7-9144-b91d-e063-6294a90a4990	2025-12-03	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	23ca78c0-16a9-455c-99a7-b9a9a3affa60	2025-12-03	Warnings	Exact identifier application number: M005
Gembooxt Nail Fungus Solution	GEMBOOXT NAIL FUNGUS SOLUTION	Guangdong Quadrant Ecological Technology Co., Ltd.	44f5c1bc-decf-beef-e063-6394a90ab562	2025-12-02	Warnings	Exact identifier application number: M005
WELMATE Clotrimazole Topical Solution	CLOTRIMAZOLE	YYBA CORP	dc5bac4a-938c-4678-89ac-a899440c6a3c	2025-12-02	Warnings	Exact identifier application number: M005
Tolnaftate Cream 1% ANTIFUNGAL	TOLNAFTATE	CARDINAL HEALTH 110 dba LEADER	bb14825c-518d-bfba-e053-2995a90a7889	2025-12-02	Warnings	Exact identifier application number: M005
ProCure Antifungal	MICONAZOLE NITRATE 2%	Twin Med LLC	3d375325-ddad-f1e1-e063-6394a90a679f	2025-12-01	Warnings	Exact identifier application number: M005
CAREALL Clotrimazole	CLOTRIMAZOLE	New World Imports, Inc	0a6cb1f7-a2a2-46a2-ae63-d205318996f0	2025-12-01	Warnings	Exact identifier application number: M005
CAREALL Miconazole Nitrate	MICONAZOLE NITRATE	New World Imports, Inc	bed775be-8bcb-44c2-9b9f-8bb25b4b2453	2025-12-01	Warnings	Exact identifier application number: M005
CAREALL Tolnaftate	TOLNAFTATE	New World Imports, Inc	cabf84c1-1500-46fe-b226-b16d4a0666c7	2025-12-01	Warnings	Exact identifier application number: M005
Trimazole	CLOTRIMAZOLE	Trifluent Pharma LLC	a3bafc52-1404-4e0b-84c1-e28bffcb091e	2025-12-01	Warnings	Exact identifier application number: M005
APUREE Pure Nailtific Extra-Strength Fungal Nail Patches	APUREE PURE NAILTIFIC EXTRA-STRENGTH FUNGAL NAIL PATCHES	Guangzhou Meixi Biotechnology Co., Ltd.	445354d8-bec2-0fd9-e063-6394a90a0099	2025-11-24	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	VALU MERCHANDISERS, CO	f4abb499-6893-9efb-e053-2995a90a33ed	2025-11-24	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE ATHLETES FOOT POWDER SPRAY TALC FREE	VALU MERCHANDISERS, CO	9ac97d4a-169b-49ff-aa34-ccb5b43726a1	2025-11-24	Warnings	Exact identifier application number: M005
Tolnafate	FOOT ODOR CONTROL POWDER SPRAY	VALU MERCHANDISERS, CO	51b69b0f-d63f-4fe0-87e6-722f95568761	2025-11-24	Warnings	Exact identifier application number: M005
Miconazole Nitrate Antifungal Powder	MICONAZOLE NITRATE ANTIFUNGAL POWDER	Marlex Pharmaceuticals, Inc.	de4f703c-39e9-855e-e053-2a95a90a6ea9	2025-11-21	Warnings	Exact identifier application number: M005
Odor-Eaters Athletes Foot	TOLNAFTATE	Blistex Inc.	20d795d1-2345-4d4f-8439-07ad11ff8f65	2025-11-21	Warnings	Exact identifier application number: M005
Derman Antifungal	ZINC UNDECYLENATE	Compania Internacional de Comercio, S.A.P.I de C.V.	0129d801-90f6-49fd-857f-27d6ba9fc66c	2025-11-19	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	9afb964c-9b88-4701-adcf-7070e25cb6c1	2025-11-19	Warnings	Exact identifier application number: M005
AU KAH CHUEN ANTIFUNGAL	CLOTRIMAZOLE	ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.	3a262bcd-e6c0-4554-ab1c-9c861f90e190	2025-11-18	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63347-511-03	63347051103	15 mL in 1 BOTTLE (63347-511-03)	15 ml	2012-09-19	0000-00-00	No	No	Current