Dr CANUSO fungal nail eraser

Product NDC: 76348-410
11-digit product format: 763480410
Labeler code: 76348
Product ID: 76348-410_350a8f7d-e332-0543-e063-6394a90a94c4
Type: HUMAN OTC DRUG
Nonproprietary name: Tolnaftate Oil
Dosage form: OIL
Route: TOPICAL
Labeler: Renu Laboratories, LLC
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-08-11
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	76348-410-02	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	76348-410-02	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	76348-410-02	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	76348-410-02	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	76348-410-02	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	76348-410-02	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	76348-410-02	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 fungal nail eraser
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
1362937	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
2083f9ed-09d6-26e6-e054-00144ff88e88	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
76348-410-02	2025-05-13	C162847	48780-1	2cef2736-79c7-d83d-e063-dadaa90ab31f	Dr. CANUSO Fungal Nail Eraser
76348-410-02	2025-01-30	C162847	48780-1	2cef2736-79c7-d83d-e063-dadaa90ab31f	Dr. CANUSO Fungal Nail Eraser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76348-410-02	Dr CANUSO fungal nail eraser	14 g in 1 BOTTLE, GLASS	OIL	14		10
76348-410-02	Dr CANUSO fungal nail eraser	1 in 1 BOX	OIL	1		10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	DR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]	5
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	DR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]	5
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	DR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]	5
CINNAMON LEAF OIL	INACTIVE INGREDIENT	S92U8SQ71V	DR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]	5
DIETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	A1A1I8X02B	DR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]	5
ETHYL MACADAMIATE	INACTIVE INGREDIENT	ANA2NCS6V1	DR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]	5
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	DR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]	5
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	DR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]	5
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)	INACTIVE INGREDIENT	587WKM3S9Q	DR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76348-410	DR CANUSO FUNGAL NAIL ERASER (TOLNAFTATE OIL) OIL [RENU LABORATORIES, LLC]	10	Current NDC, Legacy NDC, 2 package rows	20250515_2083f9ed-09d6-26e6-e054-00144ff88e88.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 5 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SERYNTH Multi-Purpose Nail Solution	TOLNAFTATE 1% MULTI-PURPOSE NAIL SOLUTION	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4af770-2bba-52a8-e063-6294a90ac287	2026-07-21	Warnings	Exact identifier application number: M005
SERYNTH Clotrimazole	CLOTRIMAZOLE1% CLOTRIMAZOLE	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4b304a-1acc-9185-e063-6394a90a1176	2026-07-21	Warnings	Exact identifier application number: M005
SERYNTH FUNGI NAIL	TOLNAFTATE 1% FUNGI NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4c6b7a-3c3e-1510-e063-6294a90a409a	2026-07-21	Warnings	Exact identifier application number: M005
SERYNTH HELPS WITH FUNGAL NAIL	TOLNAFTATE 1% HELPS WITH FUNGAL NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4c9ad1-e652-2b3b-e063-6394a90a2935	2026-07-21	Warnings	Exact identifier application number: M005
DERMFREE HELPS WITH NAGELPILZ	TOLNAFTATE 1% HELPS WITH NAGELPILZ	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4d9361-3633-59b2-e063-6294a90aa3ea	2026-07-21	Warnings	Exact identifier application number: M005
OURUI ONE FUNGAL NAIL TREATMENT	TOLNAFTATE 1% FUNGAL NAIL TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	4a473f03-f4cc-74ef-e063-6394a90ac707	2026-07-20	Warnings	Exact identifier application number: M005
AVENASTER FUNGAL NAIL CARE DUO SET (NIGHT)	UNDECYLENIC ACID 25% FUNGAL NAIL CARE DUO SET (NIGHT)	Jiangxi Yudexi Pharmaceutical Co., LTD	51eb8766-cc94-360d-e063-6294a90a6953	2026-07-20	Warnings	Exact identifier application number: M005
TINGOLE FUNGAL NAIL Patches	TOLNAFTATE 1% FUNGAL NAIL PATCHES	Jiangxi Yudexi Pharmaceutical Co., LTD	5272c6fa-75f7-c698-e063-6394a90ac81e	2026-07-20	Warnings	Exact identifier application number: M005
Vamy ANTIFUNGAL	TOLNAFTATE 1% ANTIFUNGAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4dfdf3a2-95a8-9176-e063-6294a90a64de	2026-07-20	Warnings	Exact identifier application number: M005
Antifungal cream	ANTIFUNGAL CREAM	Shenzhen Earth Surface Trading Co., Ltd.	5708cc16-9a26-fd3c-e063-6394a90ac0ee	2026-07-20	Warnings	Exact identifier application number: M005
TrpWinner TOENAIL FUNGUS PEN	UNDECYLENIC ACID 25% TOENAIL FUNGUS PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	523c2a9c-3b35-bf73-e063-6394a90ae17d	2026-07-20	Warnings	Exact identifier application number: M005
Charmpoo Antifungal Cream	MICONAZOLE NITRATE 2% ANTIFUNGAL CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	4ac347b5-d21b-cc9a-e063-6394a90a5496	2026-07-20	Warnings	Exact identifier application number: M005
Charmpoo TINEA VERSICOLOR TREATMENT ANTIFUNGAL	CLOTRIMAZOLE 1% TINEA VERSICOLOR TREATMENT ANTIFUNGAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4ac31b1d-59d7-f45c-e063-6294a90a0d3d	2026-07-20	Warnings	Exact identifier application number: M005
IraEvanes ANTIFUNGAL FOOT	TOLNAFTATE 1% ANTIFUNGAL FOOT	Jiangxi Yudexi Pharmaceutical Co., LTD	4d851a99-a453-e829-e063-6294a90a9118	2026-07-20	Warnings	Exact identifier application number: M005
LYSSERA Fungal Nail Renewal	UNDECYLENIC ACID 25% ANTIFUNGA	Jiangxi Yudexi Pharmaceutical Co., LTD	4dea6df4-e66b-c24a-e063-6294a90afca7	2026-07-20	Warnings	Exact identifier application number: M005
Kakalsa TOENAIL FUNGUS TREATMENT	UNDECYLENIC ACID 25% TOENAIL FUNGUS TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	5123c0c3-bba8-d61c-e063-6394a90aab70	2026-07-20	Warnings	Exact identifier application number: M005
SOVS FUNGAL NAIL REPAIR RENEWAL	UNDECYLENIC ACID 25% FUNGAL NAIL REPAIR RENEWAL	Jiangxi Yudexi Pharmaceutical Co., LTD	536b0c48-691e-755b-e063-6294a90a778e	2026-07-20	Warnings	Exact identifier application number: M005
Tea Tree Antifungal	CLOTRIMAZOLE	HONG KONG UNORDERED TRADING CO., LIMITED	56de35b7-b57d-1c62-e063-6294a90a757d	2026-07-18	Warnings	Exact identifier application number: M005
ACTIV-CHARCOAL ANTIFUNGAL	TOLNAFTATE	HONG KONG UNORDERED TRADING CO., LIMITED	56def103-40ef-cd88-e063-6394a90a0717	2026-07-18	Warnings	Exact identifier application number: M005
SOVS MULTI-PURPOSE NAIL REPAIR	TOLNAFTATE 1% MULTI-PURPOSE NAIL REPAIR	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56df87a7-7fc2-5ba4-e063-6394a90a652b	2026-07-18	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
1362937	tolnaftate 1 % Topical Oil	PSN	2083f9ed-09d6-26e6-e054-00144ff88e88	10
1362937	tolnaftate 10 MG/ML Topical Oil	SCD	2083f9ed-09d6-26e6-e054-00144ff88e88	10
1362937	tolnaftate 1 % Topical Oil	SY	2083f9ed-09d6-26e6-e054-00144ff88e88	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76348-410-02	76348041002	1 BOTTLE, GLASS in 1 BOX (76348-410-02) / 14 g in 1 BOTTLE, GLASS	2015-08-11	0000-00-00	No	No	Current