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 9 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LQNZJBAU Nail Repair Pen	UNDECYLENIC ACID	Guangzhou Xinhongda Trading Service Co., Ltd.	55236084-42f4-6ada-e063-6394a90ac846	2026-06-26	Warnings	Exact identifier application number: M005
VORVITA Nail Hardener	PANTHENOL,HYALURONIC ACID	HK Vorvita Technology Co., Limited	51d5d3c7-ca25-3ee5-e063-6294a90a3a05	2026-06-26	Warnings	Exact identifier application number: M005
natouch	MICONAZOLE	Natouch LLC	55210a9d-6c47-4fc7-e063-6294a90a3653	2026-06-25	Warnings	Exact identifier application number: M005
YEARCHOICE Fungal Nail Repair Pen	FUNGAL NAIL REPAIR PEN	Guangzhou Jingliang Cosmetics Co., Ltd.	5500b582-0641-498d-e063-6394a90a3c58	2026-06-24	Warnings	Exact identifier application number: M005
FIobow FUNGAL NAIL TREATMENT	TOLNAFTATE 1% FUNGAL NAIL TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	4a49db2b-e45a-57c5-e063-6294a90a065c	2026-06-23	Warnings	Exact identifier application number: M005
RoyceDerm Antifungal .spray.	CLOTRIMAZOLE 1%	RoyceDerm LLC	54d3ae29-8919-4868-e063-6294a90a587e	2026-06-22	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT LIQUID	Walgreens Company	94f4f656-e8a3-4439-b53c-12be59dc8eac	2026-06-20	Warnings	Exact identifier application number: M005
VTROUY Fungal Nail Renewal Pen	FUNGAL NAIL RENEWAL PEN	Guangzhou Jingliang Cosmetics Co., Ltd.	549bf490-99c2-c800-e063-6394a90a672b	2026-06-19	Warnings	Exact identifier application number: M005
Terramed Just Think Comfort Armor Antifungal Body Wash Tea Tree	TOLNAFTATE	Rida LLC	0c7a3b2d-8b1c-4130-86ad-892a59157480	2026-06-19	Warnings	Exact identifier application number: M005
Terramed Just Think Comfort Clotrimazole Antifungal Topical Solution	CLOTRIMAZOLE	Rida LLC	83a9c5dc-c969-43a7-a763-44783710d5d0	2026-06-18	Warnings	Exact identifier application number: M005
Anytalk FUNGAL NAIL TREATMENT	TOLNAFTATE 1%	Guangzhou Huixue Biotechnology Co., Ltd.	54718558-376f-ed31-e063-6294a90a5220	2026-06-17	Warnings	Exact identifier application number: M005
KLIPP FUNGAL NAIL TREATMENT	KLIPP FUNGAL NAIL TREATMENT	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	547f2fbe-a2de-057d-e063-6394a90ac742	2026-06-17	Warnings	Exact identifier application number: M005
GeriGentle Miconazole nitrate	ANTIFUNGAL	GERI-GENTLE CORPORATION	0ae03b4a-06c8-ddf9-e063-6294a90ad105	2026-06-16	Warnings	Exact identifier application number: M005
WKPIKI FUNGAL NAIL REPAIR PEN	UNDECYLENIC ACID 25% FUNGAL NAIL REPAIR PEN	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	54472c44-93de-d4b9-e063-6394a90adde1	2026-06-15	Warnings	Exact identifier application number: M005
BIOSHUGA Dermomucosal Antibacterial Gel	BIOSHUGA DERMOMUCOSAL ANTIBACTERIAL GEL	Guangxi Rise Biological Technology Co.,Ltd.	5456574a-dda4-9c67-e063-6294a90ac222	2026-06-15	Warnings	Exact identifier application number: M005
BIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL Solution	BIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL SOLUTION	Guangxi Rise Biological Technology Co.,Ltd.	5457a623-7812-e516-e063-6394a90a8bfd	2026-06-15	Warnings	Exact identifier application number: M005
TOYKNIER MULTI-PURPOSE TREATMENT	UNDECYLENIC ACID 25% MULTI-PURPOSE TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	4f8eb3a3-8f26-50dd-e063-6294a90ad9f8	2026-06-14	Warnings	Exact identifier application number: M005
CYYZROSE ANTIFUNGAL NAIL	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	527765d4-6988-ed4e-e063-6394a90a2f23	2026-06-14	Warnings	Exact identifier application number: M005
HEALMUSZ FUNGAL NAIL	TOLNAFTATE 1% FUNGAL NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a2317d2-e45b-1fe2-e063-6394a90a940d	2026-06-14	Warnings	Exact identifier application number: M005
HEALMUSZ FUNGI NAIL	TOLNAFTATE 1% FUNGI NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a23c01b-492d-324b-e063-6394a90a73b1	2026-06-14	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