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 47 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FIRST SHIELD	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Ever Ready First Aid	ee198aa1-ad0d-9185-e053-2a95a90a6595	2024-01-15	Warnings	Exact identifier application number: M005
Ever Ready HAND SANITIZER	ETHYL ALCOHOL	Ever Ready First Aid	ec1af7ef-3c95-9c60-e053-2a95a90acf47	2024-01-15	Warnings	Exact identifier application number: M005
MY MEDIC SUPER SANITIZER	ETHYL ALCOHOL	Sled Distribution, LLC	e7451738-75d5-5dc4-e053-2a95a90a7aee	2024-01-15	Warnings	Exact identifier application number: M005
Medical Super	ALCOHOL	Beijing HKKY Medical Tech. Co., Ltd.	ed2649c6-d971-4338-8745-cd0a40f7b0c2	2024-01-13	Warnings	Exact identifier application number: M005
ER Hand Sanitizer Packets	ALCOHOL	EVER READY FIRST AID	d0b6d09c-26e0-45c7-8d37-7d42143b2e31	2024-01-11	Warnings	Exact identifier application number: M005
clotrimazole	CLOTRIMAZOLE	Proficient Rx LP	eeb241a3-93ee-4b74-8cbb-65713d15e7e0	2024-01-01	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Proficient Rx LP	ba1dc4a4-073f-4f30-bb9c-9ed043700431	2024-01-01	Warnings	Exact identifier application number: M005
RUGBY ANTIFUNGAL CLOTRIMAZOLE	CLOTRIMAZOLE	Proficient Rx LP	7c64553b-589c-4e65-a6f0-b2847bbbe8a6	2024-01-01	Warnings	Exact identifier application number: M005
Dr. Scholls Instant Cool Athletes foot treatment with Menthol	TOLNAFTATE	Scholl's Wellness Company	dad00745-e411-35b8-e053-2a95a90a1000	2023-12-21	Warnings	Exact identifier application number: M005
TINEACIDE	TOLNAFTATE	Blaine Labs Inc.	273eb424-5dc3-40c8-9ea7-2f732cbd11c9	2023-12-21	Warnings	Exact identifier application number: M005
TERPENICOL ANTIFUNGAL	UNDECYLENIC ACID	Blaine Labs Inc.	a020334e-aac9-4ea5-a0ea-8e5b021fe2eb	2023-12-21	Warnings	Exact identifier application number: M005
TERPENICOL	UNDECYLENIC ACID	Blaine Labs Inc.	efd99ed1-07d3-4862-ae47-883f7d1c91c6	2023-12-21	Warnings	Exact identifier application number: M005
sunmark antifungal	TOLNAFTATE	A-S Medication Solutions	6f85fbb0-297c-4949-83f2-ed9a52172154	2023-12-16	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	7a0ef38a-9584-4e67-ba86-c31f86da1ed0	2023-12-11	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	7d284f6f-a970-49fe-b45a-d5c6c2688bc2	2023-12-11	Warnings	Exact identifier application number: M005
Hi Vetic	TOLNAFTATE	Sato Pharmaceutical Co., Ltd.	2096e241-3ed3-49cd-88c4-71db1fd2934a	2023-12-06	Warnings	Exact identifier application number: M005
Undecylenic Acid	UNDECYLENIC ACID	Chemco Corporation	7391b53f-5567-1f45-e053-2991aa0a4fce	2023-12-05	Warnings	Exact identifier application number: M005
Hi Vetic	TOLNAFTATE	Sato Pharmaceutical Co., Ltd.	be92b480-56e8-4371-adbc-40fe74f6747c	2023-12-01	Warnings	Exact identifier application number: M005
Antifungal Cream	ANTIFUNGAL	BluePoint Laboratories	b4c4240f-f84c-ec5e-e053-2a95a90aa082	2023-11-17	Warnings	Exact identifier application number: M005
Antifungal Cream	ANTIFUNGAL	BluePoint Laboratories	b564f971-2a9b-a605-e053-2995a90aee69	2023-11-17	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