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

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 Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui313423

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

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