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 42 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolnaftate	TOLNAFTATE	Sheffield Pharmaceuticals LLC	ca52af37-c3a2-414c-a24a-a37a92925133	2025-02-20	Warnings	Exact identifier application number: M005
Dr Sheffield Athletes Foot	CLOTRIMAZOLE	Sheffield Pharmaceuticals LLC	b8b8e6b2-1022-4592-91ba-3cf94c7cf318	2025-02-19	Warnings	Exact identifier application number: M005
UKVOA Toenail Fungus Treatment	TOLNAFTATE 1% FUNGI NAIL	Jiashen International Trade Limited	2e3cde7b-850e-f9d2-e063-6394a90adb18	2025-02-16	Warnings	Exact identifier application number: M005
UKOVA FOOT ODOR PROBIOTIC	TOLNAFTATE 1% FUNGI NAIL	Jiashen International Trade Limited	2de0225d-dd85-e2da-e063-6294a90a050b	2025-02-11	Warnings	Exact identifier application number: M005
Dr. Scholls Instant Cool Athletes Foot Wipes	TOLNAFTATE	Cosco International, Inc.	cde656a9-7841-4a73-a2f4-f5a76a3e15c1	2025-02-06	Warnings	Exact identifier application number: M005
Silka Athletes Foot	MICONAZOLE NITRATE	Genomma Lab USA	307104a2-2df6-43b0-bf3f-f4d93d3e40f1	2025-02-05	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate	MICONAZOLE NITRATE	NuCare Pharmaceuticals,Inc.	fd7dd2eb-03a7-ef1f-e053-6294a90a8557	2025-02-04	Warnings	Exact identifier application number: M005
Molecular AF	TOLNAFTATE	Renu Laboratories, LLC	1b47e687-29cf-48ce-8bc3-ac8f44f05baa	2025-02-03	Warnings	Exact identifier application number: M005
Dermatool Fungal Nail Treatment	TOLNAFTATE 1%	Papalo Group LLC	2d2c0e12-123d-75bd-e063-6394a90ae546	2025-01-31	Warnings	Exact identifier application number: M005
70% Isopropyl Alcohol	ISOPROPYL ALCOHOL	IDO PHARM	d5833c6f-81dd-6ff6-e053-2995a90ac76d	2025-01-30	Warnings	Exact identifier application number: M005
AWAS ALCOHOLSPRAY	ALCOHOL	IDO PHARM	03010837-0289-3e08-e063-6394a90a7d04	2025-01-30	Warnings	Exact identifier application number: M005
ELON Dual Defense Anti Fungal Formula	UNDECYLENIC ACID	Little Giant Holdings LLC	45c4567d-7876-6459-e054-00144ff88e88	2025-01-28	Warnings	Exact identifier application number: M005
DCH Labs Antifungal Jock	MICONAZOLE NITRATE 2%	Derma Care Research Labs, LLC	fc749882-2e1e-cad3-e053-6294a90a33ca	2025-01-27	Warnings	Exact identifier application number: M005
Antifungal Pen	UNDECYLENIC ACID 25%	XF Agencija Limited	a15d4512-0fc6-424f-9dd3-ab433d9b7a26	2025-01-27	Warnings	Exact identifier application number: M005
Mata Hongos	UNDECYLENIC ACID	Vitamex USA, Corp	21ca7edb-dde3-5846-e063-6394a90a3cc0	2025-01-23	Warnings	Exact identifier application number: M005
Povidone Iodine Scrub	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	53cb4c0d-40b5-4cf3-b122-fd6dd654883f	2025-01-23	Warnings	Exact identifier application number: M005
NATUREPLEX TOLNAFTATE ANTIFUNGAL	TOLNAFTATE	Natureplex, LLC	575b8645-9166-4242-a74f-f4aa4acaaf3d	2025-01-15	Warnings	Exact identifier application number: M005
Tobcharm Antifungal Treatment Cream	ANTIFUNGAL TREATMENT CREAM	Guangzhou Zanming Trading Co., Ltd.	2ba241cc-2767-1190-e063-6294a90ac66b	2025-01-13	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2%	MICONAZOLE NITRATE	Akron Pharma Inc.	8933f939-098a-4257-8d9c-4d5c3240e9a6	2025-01-10	Warnings	Exact identifier application number: M005
ANTI-ITCH FEMININE CARE	HYDROCORTISONE 0.5%	OL PHARMA TECH, LLC Drs PHARMACY	d6fa5ff3-ebdc-222d-e053-2a95a90a88d5	2025-01-09	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