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 45 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hongo Killer	UNDECYLENIC ACID	Efficient Laboratories Inc	5c433182-0c0c-4a0a-8dd8-a14f60e52425	2024-10-14	Warnings	Exact identifier application number: M005
Miconazole nitrate	ANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAY	Meijer Distribution Inc	6c2ebe17-994d-41c8-bacb-87b6a63b2db4	2024-10-14	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTIFUNGAL	McKesson	8dcca44a-16c7-7262-e053-2a95a90a1b23	2024-10-10	Warnings	Exact identifier application number: M005
CAREALL Clotrimazole	CLOTRIMAZOLE	New World Imports, Inc	ebc565bb-e56c-43ba-a5cb-d2fad2aafc4a	2024-10-07	Warnings	Exact identifier application number: M005
Micotrin AL	TOLNAFTATE	PureTek Corporation	cc0fba1e-82c5-42fd-e053-2995a90af249	2024-10-02	Warnings	Exact identifier application number: M005
Mycozyl AL	TOLNAFTATE	PureTek Corporation	b82c9a8a-f6f1-dca6-e053-2995a90a47f9	2024-10-02	Warnings	Exact identifier application number: M005
MY MEDIC SUPER SANITIZER	ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	f19971b1-2aeb-4c37-82b0-9525026cff7a	2024-10-02	Warnings	Exact identifier application number: M005
Micotrin AC	CLOTRIMAZOLE	PureTek Corporation	cbe4dd18-c9ef-a4e4-e053-2995a90a5289	2024-10-01	Warnings	Exact identifier application number: M005
Micotrin AP	MICONAZOLE NITRATE	PureTek Corporation	cbe3d495-cdee-2343-e053-2a95a90a5b82	2024-10-01	Warnings	Exact identifier application number: M005
Mycozyl AC	CLOTRIMAZOLE	PureTek Corporation	b676d257-3cfd-7f24-e053-2995a90a546e	2024-10-01	Warnings	Exact identifier application number: M005
Mycozyl AP	MICONAZOLE NITRATE	PureTek Corporation	b3c46a30-7ff2-0dc4-e053-2995a90aa571	2024-10-01	Warnings	Exact identifier application number: M005
AOSI HEALTHCARE HAND SANITIZER	ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	59d631d0-d8ae-45a8-a7a9-26de9cc427b3	2024-09-25	Warnings	Exact identifier application number: M005
Clotrimazole 1%	CLOTRIMAZOLE	Dabur India Limited	22916978-303f-e62a-e063-6394a90a2100	2024-09-20	Warnings	Exact identifier application number: M005
Mentholatum Heel Revival Cream	MENTHOLATUM HEEL REVIVAL CREAM	The Mentholatum Company	21b643c2-eb6e-8939-e063-6394a90aaeac	2024-09-09	Warnings	Exact identifier application number: M005
VAGISTEN-V 7 DAY	MICONAZOLE NITRATE	OPMX LLC	a5bfa501-5ae1-4434-bc31-995d0665b99e	2024-09-04	Warnings	Exact identifier application number: M005
COTTON ON FOUNDATION Tropical Hand Sanitizer	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	3645359c-06a2-4b97-b982-c54e4a0b8cda	2024-09-04	Warnings	Exact identifier application number: M005
COTTON ON FOUNDATION Coastal Hand Sanitizer	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	645c09dc-15a4-481f-a605-f12fb8f8e9bd	2024-09-04	Warnings	Exact identifier application number: M005
Publix Athletic Foot	CLOTRIMAZOLE 1%	PUBLIX SUPER MARKETS, INC.	d9f99680-5636-4136-a7c6-c3643339e6b4	2024-08-02	Warnings	Exact identifier application number: M005
ANTIFUNGAL FOOT	TOLNAFTATE	Universal Distribution Center LLC	10579848-5793-4d72-ad5f-62d191c71074	2024-07-16	Warnings	Exact identifier application number: M005
MY MEDIC SUPER SANITIZER	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	cd8f4ccd-b75e-4de0-87c0-150dfb6e0bf3	2024-07-02	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