FDA.reportPublic FDA data

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct62858-101IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage62858-10162858-101-51IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…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
IngredientStrength
TOLNAFTATE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313423Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a0df4ee5-1276-41b7-a1c4-8fcbfc7f97b5Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62858-101-512019-12-31C16284748780-19855e2a2-4c9e-60a7-e053-dbdaa90a05bdNAILRENEW (62858-101)
62858-101-512019-11-27C16284748780-19855e2a2-4c9e-60a7-e053-dbdaa90a05bdNAILRENEW (62858-101)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62858-101-11NAIL RENEW30 mL in 1 BOTTLELIQUID309
62858-101-51NAIL RENEW1 in 1 BOXLIQUID19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
TOLNAFTATEACTIVE MOIETY06KB629TKVNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
CETETH-20 PHOSPHATEINACTIVE INGREDIENT921FTA1500NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
COCO-BETAINEINACTIVE INGREDIENT03DH2IZ3FYNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
DIHEXADECYL PHOSPHATEINACTIVE INGREDIENT2V6E5WN99NNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EPNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
IMIDUREAINACTIVE INGREDIENTM629807ATLNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
OCTOXYNOL-9INACTIVE INGREDIENT7JPC6Y25QSNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3
WATERINACTIVE INGREDIENT059QF0KO0RNAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62858-101NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW CORP]8Current NDC, Legacy NDC, 2 package rows20240111_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 16 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nailtific Daytime Treatment Antifungal Pen RefillNAILTIFIC DAYTIME TREATMENT ANTIFUNGAL PEN REFILLGuangzhou Meixi Biotechnology Co., Ltd.4257ee32-0d8f-08d4-e063-6294a90a4a892026-04-11WarningsExact identifier
application number: M005
Nailtific Nighttime Antifungal Renewal Pen RefillTOLNAFTATEGuangzhou Meixi Biotechnology Co., Ltd.42634fc7-d0c7-4813-e063-6294a90a702d2026-04-11WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEChain Drug Marketing Association Inc1a4f4d10-6782-ddb4-e063-6294a90ac2062026-04-09WarningsExact identifier
application number: M005
Extra Strength Toenail Renewal SolutionUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eed68e6-6814-0181-e063-6394a90a888e2026-04-08WarningsExact identifier
application number: M005
TAGOQHIA Extra Strength NAIL REPAIR PENTOLNAFTATE, UNDECYLENIC ACIDGuangzhou Borderless Technology Co., Ltd.4eefbef4-7643-dca4-e063-6394a90a72c12026-04-08WarningsExact identifier
application number: M005
ZYNTHIXUNDECYLENIC ACID SOLUTIONShenzhen Siwei Yijiu Trading Co., Ltd.4ef4a167-f673-efb4-e063-6294a90a30262026-04-08WarningsExact identifier
application number: M005
EXTRA STRENGTH TOENAIIL RENEWAL PENUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eea5ee7-0ef9-8d34-e063-6294a90af5952026-04-07WarningsExact identifier
application number: M005
EXTRA STRENGTH TOENAIIL RENEWAL SolutionUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eeaa2f0-efc7-eab3-e063-6294a90a13b32026-04-07WarningsExact identifier
application number: M005
Extra Strength Toenail Renewal PenUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eeb59d2-3891-2e45-e063-6294a90a4fcf2026-04-07WarningsExact identifier
application number: M005
RoyceDerm Tinea ANTIFUNGAL .soap.CLOTRIMAZOLE 1%RoyceDerm LLC4e889f2b-9ea1-b1a6-e063-6394a90a46542026-04-03WarningsExact identifier
application number: M005
Dryello Tolnaftate 1% AntifungalTOLNAFTATEProPedix, Inc.4e962ca4-80ee-a379-e063-6394a90a13222026-04-03WarningsExact identifier
application number: M005
Toenail Fungus Treatment Extra Strength PenTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.28fbcc50-a3ac-d6d1-e063-6294a90aa2b62026-04-02WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT LiquidTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.28fc7049-e367-42bf-e063-6394a90a6f062026-04-02WarningsExact identifier
application number: M005
Fungal Nail PatchesTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.299a63ad-f321-117c-e063-6394a90a3a222026-04-02WarningsExact identifier
application number: M005
Secura Antifungal GreaselessMICONAZOLE NITRATESmith & Nephew Medical Ltd9be600e4-76ec-4071-a8ec-a0b23155271d2026-04-02WarningsExact identifier
application number: M005
FifthPulse Bacitracin ZincBACITRACIN ZINCWeCare Products LLC5c6b3ad8-c158-4cc0-b1ba-b829b5df12842026-04-02WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate AntifungalMICONAZOLE NITRATEWeCare Products LLCb70238eb-afcb-4e09-976f-973df249241c2026-04-02WarningsExact identifier
application number: M005
ANTIFUNGAL PENUNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDEHanyang Qisheng (Shenzhen) Technology Co., Ltd.4e85f338-ffd7-85b1-e063-6294a90a3c872026-04-02WarningsExact identifier
application number: M005
RoyceDerm Anti-Fungal CreamMICONAZOLE NITRATE 2%RoyceDerm LLC4e861073-88e8-b2f7-e063-6394a90ab94a2026-04-02WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAYCVS Pharmacy7b70d3ea-126a-42aa-8509-b982893c710b2026-04-01WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313423tolnaftate 1 % Topical SolutionPSNa0df4ee5-1276-41b7-a1c4-8fcbfc7f97b59
313423tolnaftate 10 MG/ML Topical SolutionSCDa0df4ee5-1276-41b7-a1c4-8fcbfc7f97b59
313423tolnaftate 1 % Topical SolutionSYa0df4ee5-1276-41b7-a1c4-8fcbfc7f97b59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62858-101-116285801011130 mL in 1 BOTTLE30 mlHistorical
62858-101-51628580101511 BOTTLE in 1 BOX (62858-101-51) / 30 mL in 1 BOTTLE (62858-101-11) 1 bottle2014-03-220000-00-00NoNoCurrent