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 8 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terpenicol Antifungal CreamMICONAZOLE NITRATEBlaine Labs Inc.9a4ec493-0b36-4bb8-aa9a-55cf5f79aeaa2026-07-01WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL FOOT SOAKING PACKZINC UNDECYLENATE 5% ANTIFUNGAL FOOT SOAKING PACKJiangxi Yudexi Pharmaceutical Co., LTD50044b55-8553-ca52-e063-6394a90a0e542026-07-01WarningsExact identifier
application number: M005
VENROCKUNDECYLENIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.558af06e-6fe1-c926-e063-6394a90a738c2026-07-01WarningsExact identifier
application number: M005
ANTIFUNGALMICONAZOLEVIVE HEALTH LLC30dca43e-e6c4-8107-e063-6394a90a2b972026-07-01WarningsExact identifier
application number: M005
Fungi Nail Everyday Antifungal PowderTOLNAFTATEKramer Laboratories8ed1a08a-3019-4564-968f-154e659c05e12026-07-01WarningsExact identifier
application number: M005
Terpenicol Antifungal SolutionMICONAZOLE NITRATEBlaine Labs Inc.f17ef2cd-5923-4df5-a7fe-aeef167e1e862026-07-01WarningsExact identifier
application number: M005
LUMUMU TOENAIL REPAIR PENUNDECYLENIC ACID 25% TOENAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.55763ee1-a775-731c-e063-6394a90a8f4c2026-06-30WarningsExact identifier
application number: M005
Kopa Haiku Ringworm Treatment CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd52cef8ec-6578-5e80-e063-6294a90ab4232026-06-30WarningsExact identifier
application number: M005
Tinea Versicolor Treatment CreamCLOTRIMAZOLEBeautivity LLC32d71d7e-3c78-6b63-e063-6294a90adaed2026-06-29WarningsExact identifier
application number: M005
Tinea Versicolor Treatment BarCLOTRIMAZOLEBeautivity LLC33612382-2f12-e9f6-e063-6394a90aaee42026-06-29WarningsExact identifier
application number: M005
Tinea Versicolor Treatment KitCLOTRIMAZOLEBeautivity LLC3361d9a2-daf6-7749-e063-6294a90a36532026-06-29WarningsExact identifier
application number: M005
Hermon Clotrimazole antifungal treatment creamCLOTRIMAZOLE 1%Beautivity LLC3c9bd942-49c6-cada-e063-6394a90a31662026-06-29WarningsExact identifier
application number: M005
Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate CreamTOLNAFTATE 1%Beautivity LLC4141cca0-1650-6e00-e063-6394a90a13e32026-06-29WarningsExact identifier
application number: M005
Athlete Foot Treatment KitTERBINAFINE HYDROCHLORIDE, TOLNAFTATEBeautivity LLC3b3aa69f-4e73-cabc-e063-6294a90ab65b2026-06-29WarningsExact identifier
application number: M005
Athlete Foot CreamTERBINAFINE HYDROCHLORIDEBeautivity LLC3b2c1d7f-32c3-aa3b-e063-6394a90a62672026-06-29WarningsExact identifier
application number: M005
Hermon Clotrimazole antifungal soap. barCLOTRIMAZOLE 1%Beautivity LLC3cdcf8cc-510c-6115-e063-6294a90ac3ea2026-06-29WarningsExact identifier
application number: M005
Clotrimazole antifungal treatment kitCLOTRIMAZOLE 1%Beautivity LLC3ceec52e-4089-9eb0-e063-6294a90ad52a2026-06-29WarningsExact identifier
application number: M005
Ringworm Treatment CreamMICONAZOLE NITRATE 2%Beautivity LLC4805462b-aec6-78fe-e063-6394a90ae0662026-06-29WarningsExact identifier
application number: M005
Hermon Athletes foot Tolnaftate 1% kitTOLNAFTATE 1% KITBeautivity LLC4142f490-c4b5-a9f3-e063-6394a90ab75e2026-06-29WarningsExact identifier
application number: M005
Aosorw Antifungal CreamMICONAZOLE NITRATE 2%SpineStatus LLC31f4b0eb-b8aa-7ccb-e063-6394a90ad9812026-06-29WarningsExact 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