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 32 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arflom Toenail Fungus Treatment Liquid	TOENAIL FUNGUS TREATMENT LIQUID	Guangzhou Qiexiran Cosmetics Co., Ltd.	413e76b5-263c-62fa-e063-6294a90a9214	2025-10-15	Warnings	Exact identifier application number: M005
VTROUY Fungus Nail Renewal	FUNGUS NAIL RENEWAL	Guangzhou Qiexiran Cosmetics Co., Ltd.	413f6399-dda1-8dd9-e063-6394a90a573d	2025-10-15	Warnings	Exact identifier application number: M005
Hongo Killer	UNDECYLENIC ACID	Efficient Laboratories Inc	f647308a-ea6c-47a9-a124-60e7888afac2	2025-10-14	Warnings	Exact identifier application number: M005
Tripenicol S	UNDECYLENIC ACID	Trifluent Pharma LLC	b57500e1-ea6f-4043-99d6-326a7eb57f2f	2025-10-14	Warnings	Exact identifier application number: M005
TriTolnacide C	TOLNAFTATE	Trifluent Pharma LLC	12b53c2a-b073-43db-88d9-ede8300626aa	2025-10-14	Warnings	Exact identifier application number: M005
Tritolnacide S	TOLNAFTATE	Trifluent Pharma LLC	b69ba7c9-03c1-4f5e-aa93-3ea1f2db15d8	2025-10-14	Warnings	Exact identifier application number: M005
Tripenicol C	UNDECYLENIC ACID	Trifluent Pharma LLC	0a7477da-370f-451f-8993-8c675c168696	2025-10-14	Warnings	Exact identifier application number: M005
Povidone-Iodine Prep	POVIDONE-IODINE	O&M HALYARD, INC.	f3e0af11-39b6-44a0-8f84-a4b36631e8f0	2025-10-09	Warnings	Exact identifier application number: M005
seebeellar antifungal cream 2% miconazole	SEEBEELLAR ANTIFUNGAL CREAM 2% MICONAZOLE	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	40c491f6-43b4-534e-e063-6294a90a73d6	2025-10-09	Warnings	Exact identifier application number: M005
Hermon Antifungal Jock Itch Body Wash	TOLNAFTATE 1%	Beautivity LLC	409ef5c0-dfe5-f26a-e063-6294a90a2745	2025-10-08	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Marlex Pharmaceuticals Inc	d6e95c99-e055-436a-8ee6-40d6e199eaca	2025-10-08	Warnings	Exact identifier application number: M005
TM-Clotrimazole	CLOTRIMAZOLE 1%	Singular Dreamer, Ltd dba True Marker	d6a9755a-9ed1-4e7d-8e73-25c169d6c6b1	2025-10-06	Warnings	Exact identifier application number: M005
antibacterial body wash	SILVER	Guangdong Quaker Daily Chemical Co., LTD	3fff8d3e-1944-4813-e063-6294a90a1a1d	2025-09-30	Warnings	Exact identifier application number: M005
Tobcharm Fungus Nail Renewal	FUNGUS NAIL RENEWAL	Guangzhou Qiexiran Cosmetics Co., Ltd.	4001247d-4704-8786-e063-6394a90a083a	2025-09-30	Warnings	Exact identifier application number: M005
Silka Antifungal	TOLNAFTATE	Genomma Lab USA	fb1dc636-837f-491c-97c1-e74288aebc27	2025-09-30	Warnings	Exact identifier application number: M005
Hydrocortisone 1%	HYDROCORTISONE	Chain Drug Marketing Association Inc.	3d48a3c6-b7d6-6794-e063-6294a90afff9	2025-09-29	Warnings	Exact identifier application number: M005
LEADER ATHLETES FOOT CLOTRIMAZOLE	CLOTRIMAZOLE	LEADER	dcea717b-b097-4a40-8e38-05212731a7ef	2025-09-29	Warnings	Exact identifier application number: M005
First Aid Antispetic	BENZALKONIUM CHLORIDE	Unishield	f72851ba-bbdd-5533-e053-6294a90a8216	2025-09-28	Warnings	Exact identifier application number: M005
Fungal Nail Patches	TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	3fe861cc-c972-a328-e063-6294a90afc8f	2025-09-28	Warnings	Exact identifier application number: M005
Tea Tree Oil Antifungal Foot Cream	ZINC UNDECYLENATE, UNDECYLENIC ACID	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	3fe8fc55-bd64-a4a8-e063-6294a90ad18c	2025-09-28	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