Formula 3

Product NDC: 49406-003
11-digit product format: 494060003
Labeler code: 49406
Product ID: 49406-003_3ca9d5fc-af08-41f8-e063-6394a90aaaef
Type: HUMAN OTC DRUG
Nonproprietary name: TOLNAFTATE
Dosage form: SOLUTION
Route: TOPICAL
Labeler: The Tetra Corporation
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-10-30
Substance: TOLNAFTATE
Active strength: 10 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49406-003-15	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49406-003-15	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49406-003-15	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49406-003-15	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49406-003-15	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49406-003-15	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49406-003-15	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Formula 3
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOLNAFTATE	10 mg/mL

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313423	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
0895274b-a09d-4264-a43f-852e44eb3163	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49406-003-15	2025-08-18	C162847	48780-1	2cef2736-b4bf-d83d-e063-dadaa90ab31f	0895274b-a09d-4264-a43f-852e44eb3163
49406-003-15	2025-01-30	C162847	48780-1	2cef2736-b4bf-d83d-e063-dadaa90ab31f	0895274b-a09d-4264-a43f-852e44eb3163

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49406-003-15	Formula 3	1 in 1 BOX	SOLUTION	1		22
49406-003-15	Formula 3	15 mL in 1 BOTTLE	SOLUTION	15		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49406-003-15	ML - Milliliter	49406-003	61ba9617-b5f8-4f1f-9d2e-32b3fe2d2d96	1	2016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]	5
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]	5
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]	5
APRICOT KERNEL OIL	INACTIVE INGREDIENT	54JB35T06A	FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]	5
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]	5
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]	5
RICE BRAN OIL	INACTIVE INGREDIENT	LZO6K1506A	FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]	5
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]	5
SESAME OIL	INACTIVE INGREDIENT	QX10HYY4QV	FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49406-003	FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]	19	Current NDC, Legacy NDC, 2 package rows	20231013_0895274b-a09d-4264-a43f-852e44eb3163.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 33 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Unishield Hand Sanitizer	ETHYL ALCOHOL	Unishield	eae1fc97-eb39-4353-adfa-7c549d50b5db	2025-09-24	Warnings	Exact identifier application number: M005
RUGBY ANTIFUNGAL CLOTRIMAZOLE	CLOTRIMAZOLE	Rugby Laboratories	0b32a369-ea1c-4cb8-8ea1-07bba8f16b72	2025-09-16	Warnings	Exact identifier application number: M005
SKIN TAG WART AND CORN REMOVER	SALICYLIC ACID	Zhenping Renren Industry Co., Ltd.	3e6dad69-b301-f7dc-e063-6394a90ad380	2025-09-14	Warnings	Exact identifier application number: M005
FUNGAL NAILS REPAIRING ESSENCE	PEPPERMINT OIL	Zhenping Renren Industry Co., Ltd.	3e82649c-d784-d64c-e063-6294a90ac95d	2025-09-11	Warnings	Exact identifier application number: M005
equate Athletes Foot	TOLNAFTATE	Wal-Mart Stores Inc	e90297d0-0f87-4ae3-b9b7-959266d57c24	2025-09-11	Warnings	Exact identifier application number: M005
Bee Venom Toenail Fungus Treatment	BEE VENOM TOENAIL FUNGUS TREATMENT	Shenzhen Earth Surface Trading Co., Ltd.	3e7d22b0-2f57-fcac-e063-6394a90aefd9	2025-09-10	Warnings	Exact identifier application number: M005
Amerfresh Antibacterial Deodorant	BENZETHONIUM CHLORIDE	Liufangjing Biotechnology (Yangzhou) Co., Ltd	cdc4f0ff-07bd-47c8-850b-1698308bb660	2025-09-09	Warnings	Exact identifier application number: M005
Antifungal Cream	MICONAZOLE NITRATE	Encube Ethicals, Inc.	8be4bbfa-424c-4ccf-b8bc-65b16c126053	2025-09-04	Warnings	Exact identifier application number: M005
ANTIFUNGAL	CLOTRIMAZOLE	Encube Ethicals, Inc.	afbc28f8-bb76-424d-9d73-136e6c283ead	2025-09-04	Warnings	Exact identifier application number: M005
Hermon Balanitis relief kit	SULFUR 1X HPUS	Beautivity LLC	3dce086e-a4eb-4b21-e063-6394a90aa1b2	2025-09-02	Warnings	Exact identifier application number: M005
Extra Strength Nail Fungus Treatment	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	3abc0892-e52b-a40f-e063-6294a90a0e35	2025-09-02	Warnings	Exact identifier application number: M005
Hermon Balanitis Cream	SULFUR 1X HPUS	Beautivity LLC	3dba4e4b-8224-6a96-e063-6394a90a9129	2025-09-01	Warnings	Exact identifier application number: M005
Caseys	BENZALKONIUM CHLORIDE	Zhejiang Bright Care Co., Ltd.	a29d6c19-01aa-45b0-92cd-3f1148bad4f8	2025-08-30	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREE	VALU MERCHANDISERS, CO.	1d258684-9034-460c-953d-78e2b5198167	2025-08-26	Warnings	Exact identifier application number: M005
Femmesil Maximum Strength	MICONAZOLE NITRATE	Aidance Skincare & Topical Solutions, LLC	d8b01fe1-4465-497b-909e-f51f31fdf833	2025-08-25	Warnings	Exact identifier application number: M005
femmesil Ultra Therapy	CLOTRIMAZOLE	Aidance Scientific, Inc.	3d36794a-07d0-860c-e063-6294a90a6e8f	2025-08-25	Warnings	Exact identifier application number: M005
Nedtol Folliculitis Treatment Creams	MICONAZOLE NITRATE	Jiashen International Trade Limited	3d0a1e39-82e4-9337-e063-6294a90aa9a3	2025-08-23	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	TRIFECTA PHARMACEUTICALS USA LLC	6b74d405-42d6-4c46-ba78-3007d1e8ffb8	2025-08-23	Warnings	Exact identifier application number: M005
FUNGLARA Anti Fungal	UNDECYLENIC ACID	FUNGLARA LLC	a23c2399-36ea-4f22-8140-066e22c9a862	2025-08-20	Warnings	Exact identifier application number: M005
Rapid MicroGel	TOLNAFTATE	The Tetra Corporation	afb6d7c4-1f75-4694-83c8-d6469250d6a1	2025-08-19	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313423	tolnaftate 1 % Topical Solution	PSN	0895274b-a09d-4264-a43f-852e44eb3163	22
313423	tolnaftate 10 MG/ML Topical Solution	SCD	0895274b-a09d-4264-a43f-852e44eb3163	22
313423	tolnaftate 1 % Topical Solution	SY	0895274b-a09d-4264-a43f-852e44eb3163	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49406-003-15	49406000315	1 BOTTLE in 1 BOX (49406-003-15) / 15 mL in 1 BOTTLE	1 bottle	2012-10-30	0000-00-00	No	No	Current