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 22 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Select Advanced Hand Sanitizer	ALCOHOL	Living Better Brands LLC	6d1cc25b-d612-4aae-bdb0-304758ef8f0f	2026-01-26	Warnings	Exact identifier application number: M005
clotrimazole	CLOTRIMAZOLE	Padagis Israel Pharmaceuticals Ltd	3dcd0158-ec51-4fa7-a26a-02c2926156c0	2026-01-22	Warnings	Exact identifier application number: M005
Puriya Antifungal Balm	ZINC UNDECYLENATE	IPC Republic, Inc.	96bf44bc-b5eb-4198-9056-02e51665a162	2026-01-22	Warnings	Exact identifier application number: M005
BZK Antiseptic	BENZALKONIUM CHLORIDE	Lights Medical Manufacture Co., Ltd.	698ed472-9204-46e3-95a4-d59e204628ac	2026-01-21	Warnings	Exact identifier application number: M005
LIGHTS Swabstick	BENZALKONIUM CHLORIDE	Lights Medical Manufacture Co., Ltd.	9346512e-53a1-420a-8b4d-bfbec32576a2	2026-01-21	Warnings	Exact identifier application number: M005
Lights Isopropyl Alcohol Prep Pads	ISOPROPYL ALCOHOL	Lights Medical Manufacture Co., Ltd.	4905a27c-6cf8-4b1a-a02c-4c81756e8c0a	2026-01-21	Warnings	Exact identifier application number: M005
Bee Venom Fungal Nail Treatment Liquid	BEE VENOM FUNGAL NAIL TREATMENT	Shenzhen Earth Surface Trading Co., Ltd.	48d164bc-dab6-6fe4-e063-6394a90a3fc4	2026-01-20	Warnings	Exact identifier application number: M005
Tolnaftate	MEIJER ATHLETES FOOT LIQUID SPRAY	Meijer Distribution Inc.	d9f7753f-aef9-86e2-e053-2995a90a2082	2026-01-20	Warnings	Exact identifier application number: M005
Tolnaftate	FOOT ODOR CONTROL POWDER SPRAY	Meijer Distribution Inc	b3ba676e-9377-4665-b99e-d4143df96b36	2026-01-20	Warnings	Exact identifier application number: M005
Tolnaftate	MEIJER ATHLETES FOOT LIQUID	Meijer Distribution Inc.	0399dfef-9ea6-6fe4-e063-6394a90aec43	2026-01-20	Warnings	Exact identifier application number: M005
TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH Liquid	TOLNAFTATE	Shenzhen Ctrip Technology Co., Ltd.	1fb03184-5f21-c82a-e063-6294a90a9fa4	2026-01-19	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE	AvKARE	1a26534d-eeb8-8d17-e063-6294a90a70c7	2026-01-19	Warnings	Exact identifier application number: M005
Hermon Antifungal Soap. 4 packs	TOLNAFTATE 1%	Beautivity LLC	42c769de-f1e1-b3a1-e063-6394a90ab2a1	2026-01-18	Warnings	Exact identifier application number: M005
Hermon Antifungal Cleansing Bar	TOLNAFTATE 1%	Beautivity LLC	48b5d7b3-a134-ecdd-e063-6294a90a3213	2026-01-18	Warnings	Exact identifier application number: M005
ANTIFUNGAL TOENAIL FUNGUS PEN	UNDECYLENIC ACID	Yunqi Cosmetics (Shenzhen) Co., Ltd	48b5fbd9-bdf5-21ac-e063-6394a90aa6b6	2026-01-18	Warnings	Exact identifier application number: M005
Hermon Antifungal Soap.	TOLNAFTATE 1%	Beautivity LLC	41e37014-549c-e592-e063-6294a90ac6ab	2026-01-17	Warnings	Exact identifier application number: M005
Hermon Antifungal .soap.	TOLNAFTATE 1%	Beautivity LLC	482c338f-870f-f6d7-e063-6394a90a432c	2026-01-17	Warnings	Exact identifier application number: M005
MEOLY Fungal Nail Renewal	FUNGAL NAIL RENEWAL	Shenzhen Xinxin Yunhai Technology Co., Ltd.	487d2e22-6328-893f-e063-6394a90a9dff	2026-01-16	Warnings	Exact identifier application number: M005
Lotrimin Antifungal	MICONAZOLE NITRATE	Bayer HealthCare LLC.	cebd222c-074f-443c-bd37-612114b27bbd	2026-01-16	Warnings	Exact identifier application number: M005
Lotrimin Daily Prevention	TOLNAFTATE	Bayer HealthCare LLC.	9e8f9211-e85d-725a-e053-2995a90a09b3	2026-01-16	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