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 37 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kroger Jock Itch	CLOTRIMAZOLE	Kroger Company	cc536b67-8b0b-4939-b0fb-9a9e4188c4e5	2025-07-08	Warnings	Exact identifier application number: M005
Rite Aid antifungal ringworm	CLOTRIMAZOLE	Rite Aid Corporation	1ad7cd82-d01b-403e-a2c1-2302db2a78df	2025-07-08	Warnings	Exact identifier application number: M005
Conazol	MICONAZOLE NITRATE	Laboratorios Liomont, S.A. de C.V.	84780538-8618-5750-e053-2a91aa0a6054	2025-07-07	Warnings	Exact identifier application number: M005
Clotrimazole 1% Athletes Foot	CLOTRIMAZOLE	STRATEGIC SOURCING SERVICES LLC	9aba1345-ef47-4951-8448-a43d6696b616	2025-07-07	Warnings	Exact identifier application number: M005
sunmark antifungal	TOLNAFTATE	Strategic Sourcing Services LLC	d0c30c74-9472-4978-9623-8c7dbeb99411	2025-07-07	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	a3a5cbf5-cabb-48d8-8877-74a97f7c0f57	2025-07-03	Warnings	Exact identifier application number: M005
OMZOK ANTIFUNGAL PEN	UNDECYLENIC ACID 25%	Shenzhen Shandian Jingling Technology Co., Ltd.	38edf699-93af-e550-e063-6294a90a368c	2025-07-02	Warnings	Exact identifier application number: M005
meijer Athletes Foot	CLOTRIMAZOLE	Meijer Distribution Inc	fdb15cd8-6726-4150-9b9d-6ef3ee01a5d2	2025-07-02	Warnings	Exact identifier application number: M005
meijer antifungal	TOLNAFTATE	Meijer Distribution Inc	374af35a-b8bb-4784-bfc8-c3342de875ca	2025-07-02	Warnings	Exact identifier application number: M005
Rexall Jock Itch	CLOTRIMAZOLE	Dollar General	11427a79-f262-4702-9b2e-ec1955a9b2da	2025-07-02	Warnings	Exact identifier application number: M005
Rexall Athletes Foot	CLOTRIMAZOLE	Dollar General	664579a1-a5b0-4a4c-bff6-4347f3e1d3bb	2025-07-02	Warnings	Exact identifier application number: M005
Athletes Foot Antifungal	TOLNAFTATE	Dollar General	43fc473e-c1fd-4245-af38-2e9de5ad91dc	2025-07-02	Warnings	Exact identifier application number: M005
SEFUDUN FUNGAL NAIL PATCHES	GLYCERIN	Shenzhen Shandian Jingling Technology Co., Ltd.	38db97d6-27c8-da99-e063-6294a90aac66	2025-07-01	Warnings	Exact identifier application number: M005
Tolnaftate Antifungal	TOLNAFTATE	Sun Pharmaceutical Industries, Inc.	fa16fa08-fbbd-4f45-b64a-9bffe78e8861	2025-07-01	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Granules Pharmaceuticals Inc.	1280353c-9f96-557e-e063-6294a90a10f9	2025-06-30	Warnings	Exact identifier application number: M005
Miconazole	MICONAZOLE NITRATE	Chain Drug Consortium, LLC	246be926-79ea-4e0c-a3ef-2aa7fc3a52bf	2025-06-30	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTIFUNGAL LIQUID CONTINUOUS SPRAY	Chain Drug Consortium, LLC	7f6912a6-a576-4138-bd78-a075a7d24036	2025-06-27	Warnings	Exact identifier application number: M005
Tolnaftate	ANTIFUNGAL LIQUID SPRAY	Rite Aid Corporation	aee58c44-5dba-8acb-e053-2a95a90a23af	2025-06-21	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	Rite Aid Corporation	5e2f2372-4b79-4b6a-bdea-74289b1e2053	2025-06-21	Warnings	Exact identifier application number: M005
Tolnaftate	JOCK ITCH POWDER	Rite Aid Corporation	b6968587-45c2-d2f8-e053-2a95a90a8401	2025-06-21	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