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 14 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Recuren Plus Jock Itch Cream	MICONAZOLE NITRATE 2%	REGENEREN PLUS LTD	450dab4d-168a-60b8-e063-6394a90ab303	2026-05-08	Warnings	Exact identifier application number: M005
OSIMOON FUNGAL NAIL TREATMENT Kit	FUNGAL NAIL TREATMENT KIT	Guangzhou Jingliang Cosmetics Co., Ltd.	51465ebf-3b5f-e2bf-e063-6394a90adaf2	2026-05-07	Warnings	Exact identifier application number: M005
RoyceDerm Tinea Antifungal Cream	MICONAZOLE NITRATE 2%	RoyceDerm LLC	40089a7d-c893-4e90-e063-6294a90aa6f9	2026-05-06	Warnings	Exact identifier application number: M005
QQE Fungal Nail Treatment	TOLNAFTATE 1%	Guangzhou Huixue Biotechnology Co., Ltd.	510ff705-e2cb-b77b-e063-6394a90a9e72	2026-05-05	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Akron Pharma Inc	692d7e0f-50d4-4abb-8c74-36bc98064fe7	2026-05-05	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	KJD Pharma Private Limited	5115f8e3-5668-5207-e063-6394a90a7650	2026-05-05	Warnings	Exact identifier application number: M005
NATURAL CURES FUNGAL NAIL Patches	TOLNAFTATE 1% FUNGAL NAIL PATCHES	Jiangxi Yudexi Pharmaceutical Co., LTD	510a8df7-ea6d-d634-e063-6294a90aea53	2026-05-04	Warnings	Exact identifier application number: M005
Hand Sanitizer Lemon Scented	ALCOHOL	Taizhou Juheng Biotechnology Co., Ltd.	21387234-0ac9-499d-97bf-90bccc4782ad	2026-05-04	Warnings	Exact identifier application number: M005
Uauko Fungal Nail Treatment	FUNGAL NAIL TREATMENT	Guangzhou Jingliang Cosmetics Co., Ltd.	50d16854-ab90-d6cf-e063-6294a90a21b1	2026-05-02	Warnings	Exact identifier application number: M005
NAIL RENEW	TOLNAFTATE	Nailrenew Corp	a0df4ee5-1276-41b7-a1c4-8fcbfc7f97b5	2026-05-02	Warnings	Exact identifier application number: M005
MHB SKIN HYDRATING HAND SANITIZER, CITRUS PEEL	ALCOHOL HAND SANITIZER SPRAY	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4934c20d-6295-aeb8-e063-6394a90adfeb	2026-04-30	Warnings	Exact identifier application number: M005
MHB SKIN HYDRATING HAND SANITIZER, MELON MUSE 35ml	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4931f2e4-0fef-a8c7-e063-6394a90ac16e	2026-04-30	Warnings	Exact identifier application number: M005
MINADCIN TOENAIL FUNGUS PEN	UNDECYLENIC ACID 25% TOENAIL FUNGUS PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	50a9264e-aba0-0ae2-e063-6294a90acfff	2026-04-30	Warnings	Exact identifier application number: M005
ANTIFUNGAL	UNDECYLENIC ACID	Chemco Corporation	50893584-c1c6-9ffa-e063-6394a90ae177	2026-04-29	Warnings	Exact identifier application number: M005
MHB SKIN HYDRATING HAND SANITIZER, LILY MIST	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	50949ae2-3ebe-08d2-e063-6394a90a2046	2026-04-29	Warnings	Exact identifier application number: M005
MHB SKIN HYDRATING HAND SANITIZER SANTAL WAVE 35ml	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	493120ee-0c5c-b704-e063-6394a90a8c19	2026-04-29	Warnings	Exact identifier application number: M005
ProBliva Antifungal Scrub .soap. Bar	TOLNAFTATE 1%	CAVTECH HOLDING LLC	5090a9ad-3df7-6699-e063-6394a90a72f7	2026-04-28	Warnings	Exact identifier application number: M005
FifthPulse Clotrimazole Antifungal	CLOTRIMAZOLE	WeCare Products LLC	9f5ea297-5a25-42cc-bd47-4159108b0023	2026-04-27	Warnings	Exact identifier application number: M005
YAMANGU FUNGAL NAIL REPAIR PEN	UNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL REPAIR PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	501cf54a-31da-6db2-e063-6394a90a65f8	2026-04-23	Warnings	Exact identifier application number: M005
Medicated Athletes Foot Powder	MICONAZOLE NITRATE	Premier Brands of America Inc.	38cc0c66-82b5-bac4-e063-6294a90a23f0	2026-04-23	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