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 38 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meridian Unwrapped Antibacterial Deodorant	BENZETHONIUM CHLORIDE	Liufangjing Biotechnology (Yangzhou) Co., Ltd	67d1d65a-71d4-41fc-a71c-85a28ce6de0c	2025-06-18	Warnings	Exact identifier application number: M005
Meridian Antibacterial Deodorant	BENZETHONIUM CHLORIDE	Liufangjing Biotechnology (Yangzhou) Co., Ltd	640df217-6982-441e-835a-dbe2031e732b	2025-06-18	Warnings	Exact identifier application number: M005
EYELID WIPES	EYELID WIPES	Shenzhen Shierjie Biological Engineering Co., LTD	377fb842-aa78-ab2a-e063-6394a90a69f9	2025-06-13	Warnings	Exact identifier application number: M005
Lunavia Antifungal Foot Balm	ZINC UNDECYLENATE 10%	XF Agencija Limited	466f3285-9800-4219-902f-b78a713b952f	2025-06-13	Warnings	Exact identifier application number: M005
Foot Cure Antifungal Foot Balm	ZINC UNDECYLENATE	Sansar LLC	ac6075bf-cc1d-4e8a-aa13-5a85e80f34ee	2025-06-13	Warnings	Exact identifier application number: M005
Lunavia Antifungal	UNDECYLENIC ACID 25%	XF Agencija Limited	55891d2f-e2b8-4d9f-8140-dc258926ed90	2025-06-13	Warnings	Exact identifier application number: M005
TEGASOLVE TOENAIL FUNGUS TREATMENT	UNDECYLENIC ACID 25%	Zhengzhou Hangrui Network Technology Co., Ltd.	375b0515-1b1f-23b8-e063-6294a90a9d68	2025-06-12	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE	CVS Pharmacy	979ab1d2-f184-455d-b31a-2ff2bd4592b8	2025-06-12	Warnings	Exact identifier application number: M005
Gemachlich ZuHause Fungal Nail Revitalizer	GEMACHLICH ZUHAUSE FUNGAL NAIL REVITALIZER	Guangdong Quadrant Ecological Technology Co., Ltd.	37332cdf-7171-42cc-e063-6394a90a0fcf	2025-06-10	Warnings	Exact identifier application number: M005
Eyelid Wipes	EYELID WIPES	Shenzhen Shierjie Biological Engineering Co., LTD	36ddfa37-3913-9e48-e063-6294a90ae1be	2025-06-08	Warnings	Exact identifier application number: M005
Everywhere Flushable Wipes	EVERYWHERE FLUSHABLE WIPES	Shenzhen Shierjie Biological Engineering Co., LTD	371be299-5aaf-b9d7-e063-6294a90a87f5	2025-06-08	Warnings	Exact identifier application number: M005
Fungus Master	MICONAZOLE NITRATE	Clinical Resolution Laboratory, Inc.	36eb334e-246b-249f-e063-6294a90ab811	2025-06-06	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE	Hudson Health LLC	8d725a50-fbe4-4a48-9cbf-f8b5c12dd647	2025-06-03	Warnings	Exact identifier application number: M005
CharmTex Lightly Scented Antibacterial	BENZETHONIUM CHLORIDE	Liufangjing Biotechnology (Yangzhou) Co., Ltd	1c9f4bff-3f6f-4498-b8a2-7d7f49d6ad2d	2025-06-01	Warnings	Exact identifier application number: M005
DermaD ANTIFUNGAL Therapeutic	SALICYLIC ACID	Chen Cohen Industries Inc.	b97684ae-79d0-4208-b480-67794596ece7	2025-05-29	Warnings	Exact identifier application number: M005
Fungazol Athlete Foot	MICONAZOLE NITRATE	Rida LLC	ce60e1ec-a69b-4b98-a2b2-105e9cd37bc7	2025-05-28	Warnings	Exact identifier application number: M005
Antifungal Boday Wash	TOLNAFTATE	CAVTECH HOLDING LLC	3619d717-fe42-412f-e063-6394a90a0384	2025-05-27	Warnings	Exact identifier application number: M005
Toenail Fungus Liquid	TOENAIL FUNGUS LIQUID	Shenzhen Earth Surface Trading Co., Ltd.	361f4c5c-7fa7-0440-e063-6294a90aad9f	2025-05-27	Warnings	Exact identifier application number: M005
help it Antiseptic	BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	0b22f423-eb11-445f-a484-9326c1fe3ad5	2025-05-27	Warnings	Exact identifier application number: M005
Seacall Hydrocortisone Ointment.	SEACALL HYDROCORTISONE OINTMENT	Guangdong Quadrant Ecological Technology Co., Ltd.	3616980a-03dc-deba-e063-6394a90a6ce7	2025-05-26	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