NAIL RENEW

Product NDC: 62858-101
11-digit product format: 628580101
Labeler code: 62858
Product ID: 62858-101_50dc58a9-ed7d-5126-e063-6294a90a3ad9
Type: HUMAN OTC DRUG
Nonproprietary name: TOLNAFTATE
Dosage form: LIQUID
Route: TOPICAL
Labeler: Nailrenew Corp
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-03-22
Substance: TOLNAFTATE
Active strength: 1 g/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	62858-101		I	Inactivated by FDA		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	62858-101	62858-101-51	I	Inactivated by FDA		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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: NAIL RENEW
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOLNAFTATE	1 g/100mL

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
a0df4ee5-1276-41b7-a1c4-8fcbfc7f97b5	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62858-101-51	2019-12-31	C162847	48780-1	9855e2a2-4c9e-60a7-e053-dbdaa90a05bd	NAILRENEW (62858-101)
62858-101-51	2019-11-27	C162847	48780-1	9855e2a2-4c9e-60a7-e053-dbdaa90a05bd	NAILRENEW (62858-101)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62858-101-11	NAIL RENEW	30 mL in 1 BOTTLE	LIQUID	30		9
62858-101-51	NAIL RENEW	1 in 1 BOX	LIQUID	1		9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
CETETH-20 PHOSPHATE	INACTIVE INGREDIENT	921FTA1500	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
COCO-BETAINE	INACTIVE INGREDIENT	03DH2IZ3FY	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
DIHEXADECYL PHOSPHATE	INACTIVE INGREDIENT	2V6E5WN99N	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	INACTIVE INGREDIENT	R33S7TK2EP	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
IMIDUREA	INACTIVE INGREDIENT	M629807ATL	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
OCTOXYNOL-9	INACTIVE INGREDIENT	7JPC6Y25QS	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62858-101	NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW CORP]	8	Current NDC, Legacy NDC, 2 package rows	20240111_a0df4ee5-1276-41b7-a1c4-8fcbfc7f97b5.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 7 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
iBeaLee Nail Repair Pen	IBEALEE NAIL REPAIR PEN	Shenzhen Earth Surface Trading Co., Ltd.	564dc711-7fe2-7a8d-e063-6294a90aac26	2026-07-10	Warnings	Exact identifier application number: M005
EZBIORT 1% Tolnaftate Nail Essence with Biotin	TOLNAFTATE	Guangzhou Borderless Technology Co., Ltd.	5629df38-1079-be4f-e063-6394a90a1c6a	2026-07-09	Warnings	Exact identifier application number: M005
ZENJBUST Undecylenic Acid 25% Antifungal Pen	UNDECYLENIC ACID 25% ANTIFUNGAL PEN	Shenzhen Xituo Electronics Co., Ltd	563a6704-f662-3f08-e063-6394a90a4369	2026-07-09	Warnings	Exact identifier application number: M005
Antifungal Cream	ANTIFUNGAL	Preferred Pharmaceuticals Inc.	c6098653-351a-449f-9b1a-0c617074f2b9	2026-07-08	Warnings	Exact identifier application number: M005
YEARCHOICE Fungal Nail Renewal	FUNGAL NAIL RENEWAL	Guangzhou Jingliang Cosmetics Co., Ltd.	561b650d-028c-687c-e063-6394a90a166a	2026-07-08	Warnings	Exact identifier application number: M005
CAREALL Clotrimazole	CLOTRIMAZOLE	New World Imports, Inc	561d3e64-ab9c-1074-e063-6394a90a1298	2026-07-08	Warnings	Exact identifier application number: M005
Beautifier Life ALCOHOL WIPES	BEAUTIFIER LIFE ALCOHOL WIPES	Shenzhen Shierjie Biological Engineering Co., LTD	323ef469-e37c-00ad-e063-6394a90ab6f7	2026-07-08	Warnings	Exact identifier application number: M005
Folliculitis Treatment Cream	MICONAZOLE NITRATE 2%	Guangxi Keyun E-commerce Co., Ltd.	5625652a-193d-0318-e063-6294a90a56f3	2026-07-08	Warnings	Exact identifier application number: M005
Cysndra Ringworm Cream	MICONAZOLE NITRATE, HYDROCORTISONE	Guangzhou Xinhongda Trading Service Co., Ltd.	55ed83eb-0e67-e516-e063-6394a90af443	2026-07-06	Warnings	Exact identifier application number: M005
PureWellness FUNGAL FUSION Antifungal and Antimicrobial Kit	FUNGAL FUSION ANTIFUNGAL AND ANTIMICROBIAL KIT	PureWellness LLC	25db8c55-0fa9-4795-8e05-4d3a7aaf0148	2026-07-06	Warnings	Exact identifier application number: M005
Cysndra Fungal Nail Revitalizer	UNDECYLENIC ACID	Guangzhou Xinhongda Trading Service Co., Ltd.	55e9f1cf-4055-6c27-e063-6394a90ac373	2026-07-05	Warnings	Exact identifier application number: M005
FUNGAL NAIL NIGHTTIME RENEWAL PATCHES	TOLNAFTATE 1%	100 KARMA INC	3b9ab6e0-8773-f909-e063-6394a90ac1c9	2026-07-03	Warnings	Exact identifier application number: M005
TOENAIL FUNGUS TREATMENT	25% UNDECYLENIC ACID	100 KARMA INC	3bb000dc-5e6c-b43b-e063-6394a90a63a9	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic Toenail Fungus Treatment Kit	TOENAIL FUNGUS TREATMENT	100 KARMA INC	3d4bbc65-955f-8fd8-e063-6294a90adc44	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic Nailtonic Repair Pens	25% UNDECYLENIC ACID	100 KARMA INC	4a9c32b3-e78d-3c85-e063-6394a90a7bf2	2026-07-03	Warnings	Exact identifier application number: M005
Initial Treatonic FUNGAL NAIL RENEWAL PATCHES	TOLNAFTATE 1%	100 KARMA INC	48e377b4-abb1-34cf-e063-6294a90a2ea3	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic TONENAIL FUNGUS TREATONIC kit.	25% UNDECYLENIC ACID AND TOLNAFTATE 1%	100 KARMA INC	4c197131-9ca8-6024-e063-6294a90aa9cb	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic Antifungal Pen	25% UNDECYLENIC ACID	100 KARMA INC	52d89172-e8a7-70c0-e063-6294a90a3563	2026-07-03	Warnings	Exact identifier application number: M005
FUNGINIX ANTI-FUNGAL TREATMENT	UNDECYLENIC ACID	The Sisquoc Healthcare Corporation	92db5433-5a1b-4cb9-b8eb-217c2a807a99	2026-07-02	Warnings	Exact identifier application number: M005
Anti Dandruff	KETOCONAZOLE	Guangzhou ChuanMa International Trading Co.,Ltd.	4cfe234c-49c0-18e8-e063-6294a90a0b1d	2026-07-02	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	a0df4ee5-1276-41b7-a1c4-8fcbfc7f97b5	9
313423	tolnaftate 10 MG/ML Topical Solution	SCD	a0df4ee5-1276-41b7-a1c4-8fcbfc7f97b5	9
313423	tolnaftate 1 % Topical Solution	SY	a0df4ee5-1276-41b7-a1c4-8fcbfc7f97b5	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62858-101-11	62858010111	30 mL in 1 BOTTLE	30 ml					Historical
62858-101-51	62858010151	1 BOTTLE in 1 BOX (62858-101-51) / 30 mL in 1 BOTTLE (62858-101-11)	1 bottle	2014-03-22	0000-00-00	No	No	Current