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 24 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zeasorb Athletes Foot	MICONAZOLE NITRATE	Crown Laboratories	09bb313e-90cb-5629-e063-6294a90ac268	2026-01-12	Warnings	Exact identifier application number: M005
Desenex Antifungal Foot Cream	MICONAZOLE NITRATE	Crown Laboratories, Inc.	311abb56-e176-0510-e063-6294a90a97f5	2026-01-12	Warnings	Exact identifier application number: M005
BZK Antiseptic Swab	BENZALKONIUM CHLORIDE	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	94043f4e-fe47-4b6f-8354-30697daaed81	2026-01-12	Warnings	Exact identifier application number: M005
miconazole nitrate	MICONAZOLE NITRATE	AvPAK	eaf016f6-b631-af00-e053-2a95a90adc7b	2026-01-09	Warnings	Exact identifier application number: M005
White Tetterine	MICONAZOLE NITRATE	S.S.S. Company	861895df-c989-4afd-bb31-c87c644139ef	2026-01-08	Warnings	Exact identifier application number: M005
Green Tetterine	MICONAZOLE NITRATE	S.S.S. Company	4de96ed4-7506-4acd-8e8d-ea74bfd18e4a	2026-01-08	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	The Podiatree Company	68a4e3f5-f84d-5650-e053-2a91aa0a171d	2026-01-08	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	The Podiatree Company	79234400-0766-792c-e053-2a91aa0a6e6d	2026-01-08	Warnings	Exact identifier application number: M005
Fortinia	CLOTRIMAZOLE 1%	The Podiatree Company	a003130b-77f7-4d42-8e7f-edd55176f013	2026-01-08	Warnings	Exact identifier application number: M005
Fortinia OF	CLOTRIMAZOLE 1%	The Podiatree Company	60cbd3aa-9ad7-24e4-e053-2a91aa0ab05f	2026-01-08	Warnings	Exact identifier application number: M005
Fortinia	CLOTRIMAZOLE	The Podiatree Company	60ba6f8a-8617-d4f6-e053-2991aa0a4a71	2026-01-08	Warnings	Exact identifier application number: M005
RoyceDerm Anti fungal RELIEF cream	SALICYLIC ACID 2%	RoyceDerm LLC	47ec6277-e40f-af82-e063-6294a90ac8c1	2026-01-08	Warnings	Exact identifier application number: M005
BBlove ALCOHOL WIPES	BBLOVE ALCOHOL WIPES	Shenzhen Shierjie Biological Engineering Co., LTD	1a451616-b16e-8aa7-e063-6294a90a26a1	2026-01-07	Warnings	Exact identifier application number: M005
Wet wipes	WET WIPES	Shenzhen Shierjie Biological Engineering Co., LTD	273b3ae2-6dec-31a4-e063-6294a90aca89	2026-01-07	Warnings	Exact identifier application number: M005
Bee Venom Fungal Nail Treatment Liquid	BEE VENOM FUNGAL NAIL TREATMENT	Shenzhen Earth Surface Trading Co., Ltd.	47c37468-ba5c-0d11-e063-6294a90ac554	2026-01-06	Warnings	Exact identifier application number: M005
ProBliva Anti Fungal Shampoo.	ANTIFUNGAL	CAVTECH HOLDING LLC	47af9ff8-5d5c-4524-e063-6394a90ac91f	2026-01-05	Warnings	Exact identifier application number: M005
Beauty Creations Pink Halo Hand Sanitizer Mist	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	dda9f4cb-e431-4164-be61-0daf1a86d10f	2026-01-04	Warnings	Exact identifier application number: M005
FUNGAL NAIL PATCHES	UNDECYLENIC ACID	Guangzhou Hechuang Commercial Service Co.,Ltd.	477c971d-829f-5040-e063-6394a90a41e4	2026-01-03	Warnings	Exact identifier application number: M005
Nail Renovar Plus	TOLNAFTATE	SOHM, Inc	2c09925c-e63e-4d9b-8d76-b06bd2cba26c	2026-01-02	Warnings	Exact identifier application number: M005
Natural Sense Full Body Cleansing Towel	CLEANSING TOWEL	Dr. Natural LLC	4742eec4-b7a3-2c89-e063-6294a90a19fc	2025-12-31	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