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 3 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WISH HAND SANITIZER Strawberry Musk	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	59143edb-41fe-0a1f-e063-6394a90a81a5	2026-08-15	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER Rose Woods	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	58fb4491-2918-c486-e063-6394a90a621f	2026-08-14	Warnings	Exact identifier application number: M005
VXGXO antifungal with tea tree oil	TOLNAFTATE	Guangdong Aimu Biological Technology Co., Ltd	58fd67c5-c985-13a7-e063-6294a90a40fb	2026-08-14	Warnings	Exact identifier application number: M005
Charmpoo ANTIFUNGAL BODY Cream	MICONAZOLE NITRATE 2% ANTIFUNGAL BODY CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	58ff4779-83a7-afe2-e063-6294a90a9f9a	2026-08-14	Warnings	Exact identifier application number: M005
TEATREEOILANTIFUNGAL	UNDECYLENIC ACID AND ZINC UNDECYLENATE	Foshan Chancheng District Xuntou Electronic Commerce Co., Ltd	5900904f-cf51-4398-e063-6394a90aca6c	2026-08-14	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	YYBA CORP	58f1707a-579b-1e06-e063-6294a90a5a9f	2026-08-13	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER Mango Coconut Cream	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	58faa781-520b-92fa-e063-6294a90a9ecf	2026-08-13	Warnings	Exact identifier application number: M005
Hecila ANTIFUNGAL NAIL	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	58c117cc-e039-86f6-e063-6394a90af18f	2026-08-12	Warnings	Exact identifier application number: M005
TOTCLEAR NAIL RENEWAL	UNDECYLENIC ACID	GOOD BRIDGE LLC	93605e22-920d-43c3-bb2b-6e3116a19f5e	2026-08-12	Warnings	Exact identifier application number: M005
TOTCLEAR NAIL RENEWAL	UNDECYLENIC ACID	GOOD BRIDGE LLC	fde7d6ea-1b44-4a88-820a-0f2e033727e1	2026-08-11	Warnings	Exact identifier application number: M005
XBOFPEN MULTI-PURPOSE TREATMENT	TOLNAFTATE 1% MULTI-PURPOSE TREATMENT	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	58c2f50c-9c9e-4989-e063-6394a90abb21	2026-08-11	Warnings	Exact identifier application number: M005
RoyceDerm Athletes foot antifungal .cream.	MICONAZOLE NITRATE 2%	RoyceDerm LLC	58d23aa0-497e-4ece-e063-6294a90aef66	2026-08-11	Warnings	Exact identifier application number: M005
QualiLife persimmon foot and shoe	UNDECYLENIC ACID	Guangdong Aimu Biological Technology Co., Ltd	584966c7-ceae-91af-e063-6294a90ac1eb	2026-08-10	Warnings	Exact identifier application number: M005
Persiancat ANTIFUNGAL PEN	UNDECYLENIC ACID	Guangzhou ChuanMa International Trading Co.,Ltd.	58affb96-6cfc-b1fb-e063-6294a90a340c	2026-08-10	Warnings	Exact identifier application number: M005
Dryello Tolnaftate 1% Antifungal	TOLNAFTATE	ProPedix, Inc.	58b6820c-f601-5921-e063-6294a90aa5e9	2026-08-10	Warnings	Exact identifier application number: M005
Medline	MICONAZOLE NITRATE	Medline Industries, LP	3c43ef91-bbd2-5e58-e063-6294a90a00d3	2026-08-05	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	Family Dollar Services, Inc	57c20748-fdad-b73b-e063-6294a90a1c17	2026-08-04	Warnings	Exact identifier application number: M005
Lyssera Fungal Nail Renewal	UNDECYLENIC ACID 25% FUNGAL NAIL RENEWAL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5843c1a0-ab60-bd64-e063-6294a90af858	2026-08-04	Warnings	Exact identifier application number: M005
YAMANGU FUNGAL NAIL RENEWAL	UNDECYLENIC ACID 25% FUNGAL NAIL RENEWAL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5843cc12-de66-ca47-e063-6294a90ae55b	2026-08-04	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	AmerisourceBergen Drug Corporation	58dffd8e-49ef-e03e-e063-6394a90abf5d	2026-08-04	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