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 19 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ProClearz Maximum Strength Fungal Shield Brush-on Antifungal	TOLNAFTATE	Rooftop Consumer Health, Inc.	4d451e87-c25b-49cf-92b8-747b053930c2	2026-03-02	Warnings	Exact identifier application number: M005
HAND SANITIZER lsland Coconut	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	4bf3a822-27d2-efef-e063-6294a90a0502	2026-03-01	Warnings	Exact identifier application number: M005
HAND SANITIZER Cherry Blossom	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	4bf48a93-345d-b901-e063-6394a90ab41b	2026-03-01	Warnings	Exact identifier application number: M005
HAND SANITIZER Cucumber Melon	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	4bf552a4-b8b3-6fe3-e063-6394a90a722a	2026-03-01	Warnings	Exact identifier application number: M005
HAND SANITIZER Watermelon Sugar	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	4bf57b6e-c271-b4c6-e063-6394a90a63c6	2026-03-01	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	TRIFECTA PHARMACEUTICALS USA LLC	e0a2a907-9c3a-4c4e-e053-2995a90abb91	2026-03-01	Warnings	Exact identifier application number: M005
FOLUPIA FUNGAL NAIL RENEWAL	FOLUPIA FUNGAL NAIL RENEWAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4bcacd53-9446-67ec-e063-6294a90a209e	2026-02-27	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	d6f5c6b5-5e56-462f-8c47-7986ce53669d	2026-02-25	Warnings	Exact identifier application number: M005
Lakeim FUNGAL NAIL RENEWAL Kit	FUNGAL NAIL RENEWAL KIT	Guangzhou Jingliang Cosmetics Co., Ltd.	4b6aae50-b219-beee-e063-6394a90ab415	2026-02-22	Warnings	Exact identifier application number: M005
Hermon Jock Itch spray.	MICONAZOLE NITRATE 2%	Beautivity LLC	4b633528-667a-f34e-e063-6294a90a2b3d	2026-02-21	Warnings	Exact identifier application number: M005
Lakeim Fungal Nail Repair Pen	FUNGAL NAIL REPAIR PEN	Guangzhou Jingliang Cosmetics Co., Ltd.	4b23c3a6-51da-7875-e063-6394a90a1467	2026-02-18	Warnings	Exact identifier application number: M005
OSIMOON FUNGAL NAIL RENEWAL	FUNGAL NAIL RENEWAL	Guangzhou Jingliang Cosmetics Co., Ltd.	4b113f31-1a82-a3ca-e063-6394a90a3231	2026-02-17	Warnings	Exact identifier application number: M005
Hermon Ringworm Antifungal soap.	CLOTRIMAZOLE 1%	Beautivity LLC	48405a7c-14cd-b3a0-e063-6394a90a9fc9	2026-02-13	Warnings	Exact identifier application number: M005
RoyceDerm Tea Tree Oil Antifungal soap.	TEA TREE OIL ANTIFUNGAL SOAP	RoyceDerm LLC	3a6d1e32-a38b-3dde-e063-6394a90a88f3	2026-02-13	Warnings	Exact identifier application number: M005
Happy Nuts Jock Itch Powder	MICONAZOLE NITRATE	Suit Up Brands LLC	42e2d9df-6537-b3a1-e063-6394a90a47b7	2026-02-13	Warnings	Exact identifier application number: M005
Nail Antifungal Treatment	TOLNAFTATE 1% FUNGI NAIL	BENM INC.	2ea24785-c648-4104-e063-6294a90ab12f	2026-02-12	Warnings	Exact identifier application number: M005
Hermon Ringworm Treatment Kit	MICONAZOLE NITRATE 2% AND CLOTRIMAZOLE 1%	Beautivity LLC	4a9d9c6e-0e0f-d539-e063-6294a90acb57	2026-02-12	Warnings	Exact identifier application number: M005
PHARMBANNER Antifungal Soothing Cream	ANTIFUNGAL SOOTHING CREAM	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3a077685-4177-bc0d-e063-6294a90a461b	2026-02-12	Warnings	Exact identifier application number: M005
PHARMBANNER FUNGAL NAIL RENEWAL	FUNGAL NAIL RENEWAL	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3a08ec6c-03ae-b9e5-e063-6394a90a0afb	2026-02-12	Warnings	Exact identifier application number: M005
PHARMBANNER Tinea Versicolor Cream	TINEA VERSICOLOR CREAM	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3a095194-c7ea-7f30-e063-6294a90a7ea1	2026-02-12	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