FungiFoam

Product NDC: 49406-004
11-digit product format: 494060004
Labeler code: 49406
Product ID: 49406-004_4c5c1f4d-1131-c3d0-e063-6394a90a88e2
Type: HUMAN OTC DRUG
Nonproprietary name: TOLNAFTATE
Dosage form: AEROSOL, FOAM
Route: TOPICAL
Labeler: The Tetra Corporation
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-07-13
Substance: TOLNAFTATE
Active strength: 10 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	49406-004	49406-004-30	D	Discontinued by firm		2026-10-15

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 · 21 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	49406-004-75	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49406-004-30	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	49406-004-75	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49406-004-30	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	49406-004-75	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49406-004-30	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	49406-004-75	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49406-004-30	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	49406-004-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49406-004-75	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	49406-004-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49406-004-75	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	49406-004-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49406-004-75	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: FungiFoam
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1356533	Internal RxNorm lookup
1356538	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
2449e8e5-9d7e-4119-9e7a-378efe55f875	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
49406-004-30	2025-08-18	FungiFoam ANTIFUNGAL
49406-004-75	2025-08-18	FungiFoam ANTIFUNGAL
49406-004-30	2025-01-30	FungiFoam ANTIFUNGAL
49406-004-75	2025-01-30	FungiFoam ANTIFUNGAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49406-004-30	FungiFoam	30 mL in 1 TUBE	AEROSOL, FOAM	30	19
49406-004-30	FungiFoam	1 in 1 BOX	AEROSOL, FOAM	1	19
49406-004-75	FungiFoam	75 mL in 1 BOTTLE	AEROSOL, FOAM	75	19
49406-004-75	FungiFoam	1 in 1 BOX	AEROSOL, FOAM	1	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49406-004-75	ML - Milliliter	49406-004	3b9c5268-ecd0-43ac-8cb0-0c1e227c1fb6	1	2026-05-22

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
CETEARETH-25	INACTIVE INGREDIENT	8FA93U5T67	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
DIETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	A1A1I8X02B	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
UREA	INACTIVE INGREDIENT	8W8T17847W	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49406-004	FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]	15	Current NDC, Legacy NDC, 4 package rows	20231013_2449e8e5-9d7e-4119-9e7a-378efe55f875.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 14 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Recuren Plus Jock Itch Cream	MICONAZOLE NITRATE 2%	REGENEREN PLUS LTD	450dab4d-168a-60b8-e063-6394a90ab303	2026-05-08	Warnings	Exact identifier application number: M005
OSIMOON FUNGAL NAIL TREATMENT Kit	FUNGAL NAIL TREATMENT KIT	Guangzhou Jingliang Cosmetics Co., Ltd.	51465ebf-3b5f-e2bf-e063-6394a90adaf2	2026-05-07	Warnings	Exact identifier application number: M005
RoyceDerm Tinea Antifungal Cream	MICONAZOLE NITRATE 2%	RoyceDerm LLC	40089a7d-c893-4e90-e063-6294a90aa6f9	2026-05-06	Warnings	Exact identifier application number: M005
QQE Fungal Nail Treatment	TOLNAFTATE 1%	Guangzhou Huixue Biotechnology Co., Ltd.	510ff705-e2cb-b77b-e063-6394a90a9e72	2026-05-05	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Akron Pharma Inc	692d7e0f-50d4-4abb-8c74-36bc98064fe7	2026-05-05	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	KJD Pharma Private Limited	5115f8e3-5668-5207-e063-6394a90a7650	2026-05-05	Warnings	Exact identifier application number: M005
NATURAL CURES FUNGAL NAIL Patches	TOLNAFTATE 1% FUNGAL NAIL PATCHES	Jiangxi Yudexi Pharmaceutical Co., LTD	510a8df7-ea6d-d634-e063-6294a90aea53	2026-05-04	Warnings	Exact identifier application number: M005
Hand Sanitizer Lemon Scented	ALCOHOL	Taizhou Juheng Biotechnology Co., Ltd.	21387234-0ac9-499d-97bf-90bccc4782ad	2026-05-04	Warnings	Exact identifier application number: M005
Uauko Fungal Nail Treatment	FUNGAL NAIL TREATMENT	Guangzhou Jingliang Cosmetics Co., Ltd.	50d16854-ab90-d6cf-e063-6294a90a21b1	2026-05-02	Warnings	Exact identifier application number: M005
NAIL RENEW	TOLNAFTATE	Nailrenew Corp	a0df4ee5-1276-41b7-a1c4-8fcbfc7f97b5	2026-05-02	Warnings	Exact identifier application number: M005
MHB SKIN HYDRATING HAND SANITIZER, CITRUS PEEL	ALCOHOL HAND SANITIZER SPRAY	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4934c20d-6295-aeb8-e063-6394a90adfeb	2026-04-30	Warnings	Exact identifier application number: M005
MHB SKIN HYDRATING HAND SANITIZER, MELON MUSE 35ml	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4931f2e4-0fef-a8c7-e063-6394a90ac16e	2026-04-30	Warnings	Exact identifier application number: M005
MINADCIN TOENAIL FUNGUS PEN	UNDECYLENIC ACID 25% TOENAIL FUNGUS PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	50a9264e-aba0-0ae2-e063-6294a90acfff	2026-04-30	Warnings	Exact identifier application number: M005
ANTIFUNGAL	UNDECYLENIC ACID	Chemco Corporation	50893584-c1c6-9ffa-e063-6394a90ae177	2026-04-29	Warnings	Exact identifier application number: M005
MHB SKIN HYDRATING HAND SANITIZER, LILY MIST	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	50949ae2-3ebe-08d2-e063-6394a90a2046	2026-04-29	Warnings	Exact identifier application number: M005
MHB SKIN HYDRATING HAND SANITIZER SANTAL WAVE 35ml	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	493120ee-0c5c-b704-e063-6394a90a8c19	2026-04-29	Warnings	Exact identifier application number: M005
ProBliva Antifungal Scrub .soap. Bar	TOLNAFTATE 1%	CAVTECH HOLDING LLC	5090a9ad-3df7-6699-e063-6394a90a72f7	2026-04-28	Warnings	Exact identifier application number: M005
FifthPulse Clotrimazole Antifungal	CLOTRIMAZOLE	WeCare Products LLC	9f5ea297-5a25-42cc-bd47-4159108b0023	2026-04-27	Warnings	Exact identifier application number: M005
YAMANGU FUNGAL NAIL REPAIR PEN	UNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL REPAIR PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	501cf54a-31da-6db2-e063-6394a90a65f8	2026-04-23	Warnings	Exact identifier application number: M005
Medicated Athletes Foot Powder	MICONAZOLE NITRATE	Premier Brands of America Inc.	38cc0c66-82b5-bac4-e063-6294a90a23f0	2026-04-23	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
1356538	FungiFoam 1 % Topical Foam	PSN	2449e8e5-9d7e-4119-9e7a-378efe55f875	19
1356533	tolnaftate 1 % Topical Foam	PSN	2449e8e5-9d7e-4119-9e7a-378efe55f875	19
1356538	tolnaftate 10 MG/ML Topical Foam [Fungifoam]	SBD	2449e8e5-9d7e-4119-9e7a-378efe55f875	19
1356533	tolnaftate 10 MG/ML Topical Foam	SCD	2449e8e5-9d7e-4119-9e7a-378efe55f875	19
1356538	FungiFoam 1 % Topical Foam	SY	2449e8e5-9d7e-4119-9e7a-378efe55f875	19
1356538	Fungifoam 10 MG/ML Topical Foam	SY	2449e8e5-9d7e-4119-9e7a-378efe55f875	19
1356533	tolnaftate 1 % Topical Foam	SY	2449e8e5-9d7e-4119-9e7a-378efe55f875	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49406-004-30	49406000430	1 TUBE in 1 BOX (49406-004-30) > 30 mL in 1 TUBE	1 tube	2020-07-13	0000-00-00	No	No	Current
49406-004-75	49406000475	1 BOTTLE in 1 BOX (49406-004-75) / 75 mL in 1 BOTTLE	1 bottle	2020-07-13	0000-00-00	No	No	Current