Dr. Canuso foot repair serum

Product NDC: 76348-409
11-digit product format: 763480409
Labeler code: 76348
Product ID: 76348-409_350b8fbb-d869-9503-e063-6394a90a9eb8
Type: HUMAN OTC DRUG
Nonproprietary name: Tolnaftate serum
Dosage form: LOTION
Route: TOPICAL
Labeler: Renu Laboratories, LLC
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-08-20
Substance: TOLNAFTATE
Active strength: .3 g/28g
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	76348-409-02	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	76348-409-02	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	76348-409-02	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	76348-409-02	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	76348-409-02	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	76348-409-02	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	76348-409-02	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: Dr. Canuso foot repair serum
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOLNAFTATE	.3 g/28g

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
283693	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
1fcc52c5-7030-13cb-e054-00144ff8d46c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76348-409-02	2025-05-13	C162847	48780-1	2cef2736-5c2d-d83d-e063-dadaa90ab31f	Dr. Canuso foot repair serum TM
76348-409-02	2025-01-30	C162847	48780-1	2cef2736-5c2d-d83d-e063-dadaa90ab31f	Dr. Canuso foot repair serum TM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76348-409-02	Dr. Canuso foot repair serum	28 g in 1 BOTTLE, PUMP	LOTION	28		17
76348-409-02	Dr. Canuso foot repair serum	1 in 1 BOX	LOTION	1		17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
2-HYDROXYETHYL ACRYLATE	INACTIVE INGREDIENT	25GT92NY0C	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
ACETYLATED LANOLIN ALCOHOLS	INACTIVE INGREDIENT	SNN716810P	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
CETYL ACETATE	INACTIVE INGREDIENT	4Q43814HXS	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
DEHYDROACETIC ACID	INACTIVE INGREDIENT	2KAG279R6R	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
DIETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	A1A1I8X02B	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
MENTHYL LACTATE, (-)-	INACTIVE INGREDIENT	2BF9E65L7I	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
PEG-12 DIMETHICONE (300 CST)	INACTIVE INGREDIENT	ZEL54N6W95	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
SODIUM ACRYLOYLDIMETHYLTAURATE	INACTIVE INGREDIENT	2T9Q6EKI0G	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13
WATER	INACTIVE INGREDIENT	059QF0KO0R	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, INC.]	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76348-409	DR. CANUSO FOOT REPAIR SERUM (TOLNAFTATE SERUM) LOTION [RENU LABORATORIES, LLC]	17	Current NDC, Legacy NDC, 2 package rows	20250515_1fcc52c5-7030-13cb-e054-00144ff8d46c.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 43 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	DRS. CLOTRIMAZOLE	OL PHARMA TECH,LLC	b0e9fc77-6d5c-2472-e053-2995a90a3de4	2025-01-09	Warnings	Exact identifier application number: M005
Anti-Bacterial Wipes	BENZALKONIUM CHLORIDE	Tongling Jieya Biological Technology Co., Ltd.	d7aeb18f-abf2-49bd-a8a3-ac57f60fbe7d	2025-01-04	Warnings	Exact identifier application number: M005
AVON HeXashield Athletes Foot Cream	TOLNAFTATE	Tai Guk Pharm. Co., Ltd.	8f2b6a09-8cb0-0d17-e053-2995a90aa07f	2025-01-01	Warnings	Exact identifier application number: M005
Tolnaftate	TOLNAFTATE 1%	Trifecta Pharmaceuticals USA, LLC	091b907f-544a-86c9-e063-6294a90a5d87	2024-12-31	Warnings	Exact identifier application number: M005
terrasil Fungal Treatment	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	278290f9-be14-81a8-e063-6294a90ad8cc	2024-12-26	Warnings	Exact identifier application number: M005
DEO PEDICO ABOVE NEYMAR JR MEN	DEO PEDICO ABOVE NEYMAR JR MEN	BASTON INDUSTRIA DE AEROSSOIS LTDA	ed4a9844-f20b-da5d-e053-2995a90adc09	2024-12-26	Warnings	Exact identifier application number: M005
Vite20	MICONAZOLE NITRATE	Blaine Labs Inc.	28a8d0dd-aab9-44ff-bab6-7ec4b5036a71	2024-12-24	Warnings	Exact identifier application number: M005
Vite20	UNDECYLENIC ACID	Blaine Labs Inc.	18f8ea1c-360e-43c0-98df-5816af4dec66	2024-12-24	Warnings	Exact identifier application number: M005
Tolnaftate Cream 1% ANTIFUNGAL	FAMILY WELLNESS TOLNAFTATE	Trifecta Pharmaceuticals USA, LLC	915759af-0d7f-6a87-e053-2a95a90acbd6	2024-12-20	Warnings	Exact identifier application number: M005
Rugby Clotrimazole Antifungal Cream	CLOTRIMAZOLE	Rugby Laboratories	a1365bc7-b376-adca-e053-2a95a90acf19	2024-12-20	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTIFUNGAL MICONAZOLE POWDER SPRAY	Premier Brands of America Inc.	dc7a23bb-b246-89b1-e053-2995a90a9f2d	2024-12-20	Warnings	Exact identifier application number: M005
Warrior Antifungal Foot	MICONAZOLE NITRATE 2%	Derma Care Research Labs, LLC	cf2e9dc1-275b-4454-e053-2995a90af295	2024-12-20	Warnings	Exact identifier application number: M005
Tolnaftate Cream 1%	TOLNAFTATE	Pharmacy Value Alliance, LLC.	3abfd734-229b-1a0e-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M005
Dermatool Fungal Nail Treatment	TOLNAFTATE 1%	Derma Care Research Labs, LLC	fbc1a55e-b994-4962-e053-6394a90a13ba	2024-12-19	Warnings	Exact identifier application number: M005
Novonail Solution	TOLNAFTATE 1%	Derma Care Research Labs, LLC	013d6107-e3b0-0264-e063-6394a90ae1e2	2024-12-19	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Rugby	f420de00-408f-9a2c-e053-2995a90adced	2024-12-17	Warnings	Exact identifier application number: M005
Relispray Antifungal Liquid	TOLNAFTATE	Midas-Care Pharmaceuticals Pvt. Ltd.	6522ad59-f810-408c-a9f9-9359d79302ce	2024-12-17	Warnings	Exact identifier application number: M005
Clotrimazole	FAMILY WELLNESS CLOTRIMAZOLE	Trifecta Pharmaceuticals USA LLC	915759af-0d7b-6a87-e053-2a95a90acbd6	2024-12-13	Warnings	Exact identifier application number: M005
Blistex Odor-Eaters Powder	TOLNAFTATE	Blistex Inc	819edb2f-dda7-45c3-b0da-ebcae354154e	2024-12-12	Warnings	Exact identifier application number: M005
Walgreens Athletes Foot	TOLNAFTATE SPRAY	Walgreens	c68ad65d-b016-0069-e053-2995a90ae7ef	2024-12-11	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
283693	tolnaftate 1 % Topical Lotion	PSN	1fcc52c5-7030-13cb-e054-00144ff8d46c	17
283693	tolnaftate 10 MG/ML Topical Lotion	SCD	1fcc52c5-7030-13cb-e054-00144ff8d46c	17
283693	tolnaftate 1 % Topical Lotion	SY	1fcc52c5-7030-13cb-e054-00144ff8d46c	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76348-409-02	76348040902	1 BOTTLE, PUMP in 1 BOX (76348-409-02) / 28 g in 1 BOTTLE, PUMP	2015-08-20	0000-00-00	No	No	Current