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 20 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHARMBANNER TINEA VERSICOLOR Cream	TINEA VERSICOLOR CREAM	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3db832f4-630d-72a2-e063-6394a90a08dc	2026-02-12	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREE	Chain Drug Consortium, LLC	5f9edcf9-b99e-65a2-e053-2a91aa0af565	2026-02-12	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE POWDER SPRAY	Chain Drug Consortium, LLC	5fafc16d-7257-fc88-e053-2991aa0a67c4	2026-02-12	Warnings	Exact identifier application number: M005
Kerova Miconazole Nitrate	MICONAZOLE NITRATE	Guangzhou Bixiaoyu Trading Co., Ltd.	3b8b5547-f8d1-9e48-e063-6294a90af429	2026-02-12	Warnings	Exact identifier application number: M005
natouch	MICONAZOLE	Natouch LLC	a980ff33-2b6d-3065-e053-2995a90ae974	2026-02-11	Warnings	Exact identifier application number: M005
Tuymec Antifungal Medicated Bar	ANTIFUNGAL MEDICATED BAR	Guangzhou Jingliang Cosmetics Co., Ltd.	4a8265c5-9c69-a36a-e063-6294a90ab292	2026-02-11	Warnings	Exact identifier application number: M005
Tuymec FUNGAL NAIL TREATMENT Kit	FUNGAL NAIL TREATMENT KIT	Guangzhou Jingliang Cosmetics Co., Ltd.	4a983b42-9723-7a3a-e063-6394a90ae7b2	2026-02-11	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT SPRAY	CVS Pharmacy	1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3c	2026-02-10	Warnings	Exact identifier application number: M005
Kerova ANTIFUNGAL	CLOTRIMAZOLE	Guangzhou Bixiaoyu Trading Co., Ltd.	4a7b48cf-72c3-be63-e063-6394a90a1efe	2026-02-10	Warnings	Exact identifier application number: M005
Kerova Clotrimazole	ANTIFUNGAL	Guangzhou Bixiaoyu Trading Co., Ltd.	4a7b9658-f411-299d-e063-6394a90af9ce	2026-02-10	Warnings	Exact identifier application number: M005
natouch	MICONAZOLE	Natouch LLC	3b1209fc-9d6b-2f55-e063-6394a90ac2ad	2026-02-10	Warnings	Exact identifier application number: M005
Nabrace Wipes for Ringworm, Jockitch and Athlete Feet	NABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEET	Nabrace LLC	0fdd1658-5759-8a42-e063-6394a90a7271	2026-02-10	Warnings	Exact identifier application number: M005
APUREE Nailtific Extra-Max Strength Antigungal	APUREE NAILTIFIC EXTRA-MAX STRENGTH ANTIGUNGAL	Guangzhou Meixi Biotechnology Co., Ltd.	4a633da8-dcba-349c-e063-6294a90a7702	2026-02-09	Warnings	Exact identifier application number: M005
Fungus Master Antifungal Treatment	MICONAZOLE NITRATE	Ebanel Laboratories, Inc	f7b011b2-11e5-46f1-afed-89f438985e00	2026-02-09	Warnings	Exact identifier application number: M005
OSIMOON Toenail Fungus Treatment	TOENAIL FUNGUS TREATMENT	Guangzhou Jingliang Cosmetics Co., Ltd.	4a7061a9-8ba2-72b8-e063-6294a90a4d9a	2026-02-09	Warnings	Exact identifier application number: M005
CLOTRIMAZOLE 1%	CLOTRIMAZOLE	PHARMACY CHOICE INC	43852cfb-6d28-e54f-e063-6394a90aa090	2026-02-08	Warnings	Exact identifier application number: M005
ASSIELF ANTIFUNGAL PEN	UNDECYLENIC ACID	Shenzhen Yuanbang International Logistics Co., Ltd	4a5d8e86-6401-7556-e063-6394a90acce1	2026-02-08	Warnings	Exact identifier application number: M005
Dryello Dual Action Relief for Athlete Foot	TOLNAFTATE	ProPedix, Inc.	359478dd-02c9-05e5-e063-6294a90a41ed	2026-02-06	Warnings	Exact identifier application number: M005
HEALMUSZ Clotrimazole	CLOTRIMAZOLE1% MICONAZOLE1% CLOTRIMAZOLE	Jiangxi Yudexi Pharmaceutical Co., LTD	4a326159-a6a7-c1d6-e063-6294a90a3b89	2026-02-06	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	Wal-Mart Stores, Inc.	17d0486e-e8b5-3afe-e063-6394a90aa384	2026-02-04	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