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 14 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOTRIMAZOLE	CLOTRIMAZOLE	Rugby Laboratories, Inc.	2c60e631-5930-4420-886d-eb1990c720b6	2026-05-11	Warnings	Exact identifier application number: M005
Tolfyra	TOLNAFTATE	Oncora Pharma, LLC	b28ee9f2-fc45-4336-b374-be7aa51d44e9	2026-05-11	Warnings	Exact identifier application number: M005
clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	c0f58a0d-a304-41f9-bbdf-c2e488230cf0	2026-05-11	Warnings	Exact identifier application number: M005
Inlifay ANTIFUNGAL	TOLNAFTATE	Guangdong Aimu Biological Technology Co., Ltd	5148b838-d26e-cf66-e063-6394a90ae469	2026-05-09	Warnings	Exact identifier application number: M005
HuiPoLii NAIL PFLASTER	TOLNAFTATE 1% NAIL PFLASTER	Jiangxi Yudexi Pharmaceutical Co., LTD	514b1c2d-cecb-30a2-e063-6394a90af266	2026-05-08	Warnings	Exact identifier application number: M005
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 ndc (product): 62858-101
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

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