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 35 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONIADBA Fungal Nail Treatment Swabs	TOLNAFTATE,UNDECYLENIC ACID	Shenzhen Boyimei Technology Co., Ltd.	3baa99ab-6d22-8d7d-e063-6294a90af3e8	2025-08-05	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	cca84334-2e2d-4991-9d1e-d5b7c9ffd392	2025-08-01	Warnings	Exact identifier application number: M005
RoyceDerm CoolDefense Refreshing Shower Gel	TOLNAFTATE 1.0%	RoyceDerm LLC	3b3216d6-8cc8-ea89-e063-6294a90ab691	2025-07-31	Warnings	Exact identifier application number: M005
SUNMARK MICONAZOLE NITRATE antifungal	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	7c15d95a-5b89-4789-8c91-3f61d7ec7707	2025-07-30	Warnings	Exact identifier application number: M005
Antifungal	MICONAZOLE NITRATE	Advanced Rx LLC	e13eb653-3916-444a-ae86-1738c0308b79	2025-07-28	Warnings	Exact identifier application number: M005
Meridian Unwrapped Antibacterial Deodorant	BENZETHONIUM CHLORIDE	Yangzhou Hongshengding Chemical Co.,Ltd.	a2b9570f-312c-4f46-994d-efe057b247aa	2025-07-28	Warnings	Exact identifier application number: M005
Meridian Antibacterial Deodorant	BENZETHONIUM CHLORIDE	Yangzhou Hongshengding Chemical Co.,Ltd.	b41b130f-48fd-47d4-a94e-74433ae44de2	2025-07-28	Warnings	Exact identifier application number: M005
Rugby Clotrimazole Antifungal Cream	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	bd567e91-7152-4612-83e0-8e8a00c2d2c5	2025-07-25	Warnings	Exact identifier application number: M005
Hongocura	UNDECYLENIC ACID, ZINC UNDECYLENATE	MENPER DISTRIBUTORS, INC.	c69b735e-0ffe-4328-bd9f-3c1ac6798c08	2025-07-22	Warnings	Exact identifier application number: M005
Hongocura Pinceladas	UNDECYLENIC ACID	Menper Distributors, Inc.	4b9a3a70-d646-47c6-b969-5c4d759d23a4	2025-07-22	Warnings	Exact identifier application number: M005
Hongocura M	UNDECYLENIC ACID	MENPER DISTRIBUTORS, INC.	b4adb7b0-59b4-4b3c-9b0e-1869bb543174	2025-07-22	Warnings	Exact identifier application number: M005
Hongocura S	UNDECYLENIC ACID	MENPER DISTRIBUTORS, INC.	4a21f371-bfc1-4e66-af16-55b3283872b7	2025-07-22	Warnings	Exact identifier application number: M005
FifthPulse Miconazole Nitrate Cream 1oz	MICONAZOLE NITRATE	Front Pharmaceutical PLC	3a37a3a8-9d05-926c-e063-6294a90a9ed8	2025-07-18	Warnings	Exact identifier application number: M005
FifthPulse Miconazole Nitrate Cream 4oz	MICONAZOLE NITRATE	Front Pharmaceutical PLC	3a382b79-dde9-dde0-e063-6294a90a53bb	2025-07-18	Warnings	Exact identifier application number: M005
FifthPulse clotrimazole cream 4oz	CLOTRIMAZOLE 1%	Front Pharmaceutical PLC	3a389093-48f2-29cb-e063-6294a90ada37	2025-07-18	Warnings	Exact identifier application number: M005
PHARMBANNER Tea Tree Oil Antifungal Soap.	TEA TREE OIL ANTIFUNGAL SOAP.	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3a0860b0-346e-7024-e063-6394a90ace81	2025-07-16	Warnings	Exact identifier application number: M005
TopCare Antifungal	CLOTRIMAZOLE	Topco Associates LLC	6757eb2a-73e0-4bd0-a332-5713fdf3445d	2025-07-16	Warnings	Exact identifier application number: M005
UpandUp Clotrimazole	CLOTRIMAZOLE	Target Corporation	cb2b7d38-9988-493b-9843-56c2f59eed2f	2025-07-16	Warnings	Exact identifier application number: M005
Jock Itch	CLOTRIMAZOLE	TARGET Corporation	1ae551e7-69de-4eef-b4f7-5e1a880e631d	2025-07-16	Warnings	Exact identifier application number: M005
Athletes Foot	CLOTRIMAZOLE	FRED'S, INC.	d2d8f44e-2dfa-446b-855e-86e0d6d2d0df	2025-07-15	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