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 17 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Velloryn ANTIFUNGAL Cream	ZINC UNDECYLENATE, UNDECYLENIC ACID	Guangdong Quadrant Ecological Technology Co., Ltd.	4e38e1f1-0466-5b91-e063-6294a90a66c4	2026-03-30	Warnings	Exact identifier application number: M005
APUREE Nailtific Extra-Max Strength Daytime Antigungal	APUREE NAILTIFIC EXTRA-MAX STRENGTH DAYTIME ANTIGUNGAL	Guangzhou Meixi Biotechnology Co., Ltd.	4e3d226b-57f1-75a6-e063-6394a90a96cd	2026-03-30	Warnings	Exact identifier application number: M005
APUREE Nailtific Extra-Max Strength Nighttime Antifungal	APUREE NAILTIFIC EXTRA-MAX STRENGTH NIGHTTIME ANTIFUNGAL	Guangzhou Meixi Biotechnology Co., Ltd.	4e3e8895-34b4-de69-e063-6294a90a5532	2026-03-30		Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	CVS Pharmacy	3380263d-ee7b-4946-a467-35a24789a901	2026-03-27	Warnings	Exact identifier application number: M005
Micro-Guard (AF)	MICONAZOLE NITRATE	Coloplast Corp	a43a94d0-fec0-470f-bdb4-535dcce6d1e0	2026-03-27	Warnings	Exact identifier application number: M005
Suave Antibacterial Hand Wash Fresh Citrus	LIQUID HAND WASH ANTIBACTERIAL	Suave Brands Co, LLC	41d77ec6-a1d1-13dc-e063-6394a90a95f4	2026-03-26	Warnings	Exact identifier application number: M005
Suave Antibacterial Hand Wash Deeply Clean	LIQUID HAND WASH ANTIBACTERIAL	Suave Brands Co, LLC	41d83736-66da-abb9-e063-6294a90a3d67	2026-03-26	Warnings	Exact identifier application number: M005
Suave Antibacterial Hand Wash Sea Minerals and Aloe Vera	LIQUID HAND WASH ANTIBACTERIAL	Suave Brands Co, LLC	41d8848c-d157-6e2c-e063-6294a90aa259	2026-03-26	Warnings	Exact identifier application number: M005
Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock Itch	ANTIFUNGAL TREATMENT KIT	Beautivity LLC	4800a93b-7042-827b-e063-6294a90acd95	2026-03-25	Warnings	Exact identifier application number: M005
Toenail Fungus Treatment	TERBINAFINE	Shenzhen Wankelai E-commerce Co., Ltd.	4dc1d7f7-e4ae-c54b-e063-6394a90aa420	2026-03-24	Warnings	Exact identifier application number: M005
Lasolex Liquid Solution	CLOTRIMAZOLE 1%	PureTek Corporation	4dc9e64d-8235-b218-e063-6394a90a0157	2026-03-24	Warnings	Exact identifier application number: M005
Hermon Jock Itch Antifungal Treatment .Soap. Bar	TOLNAFTATE 1%	Beautivity LLC	4dbbf09b-5bc1-501b-e063-6394a90a2a9d	2026-03-23	Warnings	Exact identifier application number: M005
Hermon Jock Itch Antifungal Treatment Cream	MICONAZOLE NITRATE 2%	Beautivity LLC	4dbc521c-2f5f-9736-e063-6294a90ad85d	2026-03-23	Warnings	Exact identifier application number: M005
seebeellar clotrimazole 1% antifungal cream	SEEBEELLAR CLOTRIMAZOLE 1% ANTIFUNGAL CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	4d80e551-76c2-150a-e063-6394a90a7996	2026-03-20	Warnings	Exact identifier application number: M005
Nail Fungal Pen	UNDECYLENIC ACID	Guangzhou Hechuang Commercial Service Co.,Ltd.	4d5b5c22-4781-6391-e063-6294a90a7010	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER MADRID MUSE	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d5cecf6-c232-6cd9-e063-6394a90a03e9	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER VALENCIA VIBES	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d5de4d6-4c58-f393-e063-6294a90a323a	2026-03-19	Warnings	Exact identifier application number: M005
Toenail Fungus Pen	UNDECYLENIC ACID	Guangzhou Hechuang Commercial Service Co.,Ltd.	4d5e256f-7fd5-f903-e063-6394a90a1160	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER MALLORCA BREEZE	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d5e50de-62fd-f9e9-e063-6394a90af0bd	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER MAR BELLA	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d6005d9-5d4d-033e-e063-6294a90ad36f	2026-03-19	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