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 6 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FUNGAL NAIL TREATMENT kit .liquid.	PSEUDOLARIX AMABILIS BARK 1%	GETHSEMANE BRANCH CORPORATION	56c93390-ee07-4f78-e063-6394a90add42	2026-07-17	Warnings	Exact identifier application number: M005
FUNGAL NAIL TREATMENT kit .cream.	PSEUDOLARIX AMABILIS BARK 1%	GETHSEMANE BRANCH CORPORATION	56c9d9fa-09ad-e26a-e063-6394a90a0ed9	2026-07-17	Warnings	Exact identifier application number: M005
FUNGAL NAIL TREATMENT kit	PSEUDOLARIX AMABILIS BARK 1%	GETHSEMANE BRANCH CORPORATION	56cb7085-87d8-4273-e063-6394a90ac5df	2026-07-17	Warnings	Exact identifier application number: M005
BeamBalm ANTIFUNGAL FOOT CARE	TOLNAFTATE 1% ANTIFUNGAL FOOT CARE	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56b10492-894c-33e1-e063-6394a90a8c0f	2026-07-17	Warnings	Exact identifier application number: M005
Foot Choice-Nail Fungal Pen	UNDECYLENIC ACID	Foot Choice LLC	4b0036a6-8751-4f44-b6b1-5be57fa92cdc	2026-07-17	Warnings	Exact identifier application number: M005
2% MICONAZOLE NITRATE ANTIFUNGAL Cream	2% MICONAZOLE NITRATE ANTIFUNGAL CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	56b54359-db21-b8b4-e063-6394a90a6f8c	2026-07-16	Warnings	Exact identifier application number: M005
DRAVYNOR BALANITIS RELIEF Cream	MICONAZOLE NITRATE 2% BALANITIS RELIEF CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56b76a52-0743-4fe6-e063-6294a90a98a8	2026-07-16	Warnings	Exact identifier application number: M005
5% Benzoyl Peroxide FOLLICULITIS Cream	5% BENZOYL PEROXIDE FOLLICULITIS CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	56c558fa-303f-fc52-e063-6394a90a72f0	2026-07-16	Warnings	Exact identifier application number: M005
Antifungal Ringworm Treatment Cream	MICONAZOLE NITRATE	Yunqi Cosmetics (Shenzhen) Co., Ltd	56a2ceea-c4c0-c30c-e063-6394a90a0e6a	2026-07-15	Warnings	Exact identifier application number: M005
Medi-First Antifungal Cream Miconazole Cream	MICONAZOLE	Unifirst First Aid Corporation	56a51b75-9c23-bcd2-e063-6394a90a9b12	2026-07-15	Warnings	Exact identifier application number: M005
Clear Root Labs Tinea Treatment	CLEAR ROOT LABS TINEA TREATMENT	Aidance Scientic Inc., DBA Aidance Skincare & Topicals	56a67bad-c677-d3b7-e063-6394a90ad205	2026-07-15	Warnings	Exact identifier application number: M005
Clear Root Labs Antifungal Treatment	CLEAR ROOT LABS ANTIFUNGAL TREATMENT	Aidance Scientific, Inc., DBA Aidance Skincare & Topicals	5696bf23-230a-5f37-e063-6294a90a7413	2026-07-15	Warnings	Exact identifier application number: M005
BeamBalm ANTIFUNGAL NAIL Liquid	TOLNAFTATE 1% ANTIFUNGAL NAIL LIQUID	Jiangxi Yudexi Pharmaceutical Co., LTD	56b17e50-bff1-5eb0-e063-6294a90a3c08	2026-07-15	Warnings	Exact identifier application number: M005
terrasil Antifungal Cleansing Bar	CLOTRIMAZOLE	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	10a4fde0-87e1-4474-bcb5-255b0a7f1ecb	2026-07-14	Warnings	Exact identifier application number: M005
OAKDOLCHE Tea Tree Oil Antifungal	TOLNAFTATE	Nanjing Qiaotun Technology Co., Ltd.	569dee15-e68d-220e-e063-6294a90af7c5	2026-07-14	Warnings	Exact identifier application number: M005
Kimtara Nail Fungus Treatment	KIMTARA NAIL FUNGUS TREATMENT	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	5678e260-10c4-f203-e063-6294a90a6223	2026-07-13	Warnings	Exact identifier application number: M005
Aiilo NAIL FUNGUS TREATMENT	UNDECYLENIC ACID 25%	Guangzhou Huixue Biotechnology Co., Ltd.	5689ac31-4d23-0fcc-e063-6394a90ac75b	2026-07-13		Exact identifier application number: M005
MIWIFY ANTIFUNGAL NAIL REPAIR PEN	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL REPAIR PEN	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56519b25-f3c8-bcac-e063-6394a90af879	2026-07-11	Warnings	Exact identifier application number: M005
Joymeey FUNGAL NAIL RENEWAL	UNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL RENEWAL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5652a22e-7b43-3c31-e063-6294a90ae4f1	2026-07-11	Warnings	Exact identifier application number: M005
iBeaLee Nail Repair Pen	IBEALEE NAIL REPAIR PEN	Shenzhen Earth Surface Trading Co., Ltd.	564dc711-7fe2-7a8d-e063-6294a90aac26	2026-07-10	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