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 16 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EXTRA STRENGTH TOENAIIL RENEWAL PEN	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eea5ee7-0ef9-8d34-e063-6294a90af595	2026-04-07	Warnings	Exact identifier application number: M005
EXTRA STRENGTH TOENAIIL RENEWAL Solution	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eeaa2f0-efc7-eab3-e063-6294a90a13b3	2026-04-07	Warnings	Exact identifier application number: M005
Extra Strength Toenail Renewal Pen	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eeb59d2-3891-2e45-e063-6294a90a4fcf	2026-04-07	Warnings	Exact identifier application number: M005
RoyceDerm Tinea ANTIFUNGAL .soap.	CLOTRIMAZOLE 1%	RoyceDerm LLC	4e889f2b-9ea1-b1a6-e063-6394a90a4654	2026-04-03	Warnings	Exact identifier application number: M005
Toenail Fungus Treatment Extra Strength Pen	TOLNAFTATE, UNDECYLENIC ACID	Lianjiang Shanlilai E-commerce Co., Ltd.	28fbcc50-a3ac-d6d1-e063-6294a90aa2b6	2026-04-02	Warnings	Exact identifier application number: M005
TOENAIL FUNGUS TREATMENT Liquid	TOLNAFTATE, UNDECYLENIC ACID	Lianjiang Shanlilai E-commerce Co., Ltd.	28fc7049-e367-42bf-e063-6394a90a6f06	2026-04-02	Warnings	Exact identifier application number: M005
Fungal Nail Patches	TOLNAFTATE, UNDECYLENIC ACID	Lianjiang Shanlilai E-commerce Co., Ltd.	299a63ad-f321-117c-e063-6394a90a3a22	2026-04-02	Warnings	Exact identifier application number: M005
Secura Antifungal Greaseless	MICONAZOLE NITRATE	Smith & Nephew Medical Ltd	9be600e4-76ec-4071-a8ec-a0b23155271d	2026-04-02	Warnings	Exact identifier application number: M005
FifthPulse Bacitracin Zinc	BACITRACIN ZINC	WeCare Products LLC	5c6b3ad8-c158-4cc0-b1ba-b829b5df1284	2026-04-02	Warnings	Exact identifier application number: M005
FifthPulse Miconazole Nitrate Antifungal	MICONAZOLE NITRATE	WeCare Products LLC	b70238eb-afcb-4e09-976f-973df249241c	2026-04-02	Warnings	Exact identifier application number: M005
ANTIFUNGAL PEN	UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE	Hanyang Qisheng (Shenzhen) Technology Co., Ltd.	4e85f338-ffd7-85b1-e063-6294a90a3c87	2026-04-02	Warnings	Exact identifier application number: M005
RoyceDerm Anti-Fungal Cream	MICONAZOLE NITRATE 2%	RoyceDerm LLC	4e861073-88e8-b2f7-e063-6394a90ab94a	2026-04-02	Warnings	Exact identifier application number: M005
Miconazole Nitrate	JOCK ITCH SPRAY	CVS Pharmacy	7b70d3ea-126a-42aa-8509-b982893c710b	2026-04-01	Warnings	Exact identifier application number: M005
Fungicure Anti-Fungal Liquid	TOLNAFTATE	Kobayashi Healthcare International, Inc.	b18ee199-0659-733c-e053-2a95a90ab6b5	2026-04-01	Warnings	Exact identifier application number: M005
Tolnaftate	ANTIFUNGAL LIQUID SPRAY	CVS Pharmacy	96cc594d-85c8-4f62-bc0a-3176c8739f21	2026-04-01	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE POWDER SPRAY	CVS Pharmacy	a7b6bd7c-23db-43e1-92f7-e27f5f4801de	2026-04-01	Warnings	Exact identifier application number: M005
Baza Antifungal	MICONAZOLE NITRATE	Coloplast Corp	75182cb7-840a-423a-9c20-10840d6e1d65	2026-03-31	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Trifecta Pharmaceuticals Usa Llc	80217dbb-a0f0-414a-8d22-a9a346b017aa	2026-03-31	Warnings	Exact identifier application number: M005
RoyceDerm Antifungal Bar	CLOTRIMAZOLE	RoyceDerm LLC	3abdc4a8-58dd-5bd0-e063-6294a90a1bca	2026-03-31	Warnings	Exact identifier application number: M005
Critic Aid Clear AF	MICONAZOLE NITRATE	Coloplast Corp	cbc5d976-850a-476e-b179-b7a5a8675524	2026-03-31	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