FDA.reportPublic FDA data

Permethrin

Product NDC
52959-159
11-digit product format
529590159
Labeler code
52959
Product ID
52959-159_525aa3b8-7fde-4683-959e-d3da10140cb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Permethrin
Dosage form
CREAM
Route
TOPICAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA076369
Marketing category
ANDA
Marketing start
2006-08-11
Marketing end
0000-00-00
Substance
PERMETHRIN
Active strength
50 mg/g
Pharmacologic classes
Pyrethrins [CS],Pyrethroid [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
f33e3e13-1328-47a9-3012-134a14fcb6a1Product name220190703

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-159-062019-11-13C16284748780-197449f38-c509-f6ea-e053-dbdaa90aa703Permethrin Cream, 5%*

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-159-06Permethrin60 g in 1 TUBECREAM601
52959-159-06Permethrin1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-159-06GM - Gram52959-159cfb19e05-0636-4f3e-8c13-dce0179abcbe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PERMETHRINACTIVE INGREDIENT509F88P9SZPERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.]1
PERMETHRINACTIVE MOIETY509F88P9SZPERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KPERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.]1
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK31PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.]1
CETETH-20INACTIVE INGREDIENTI835H2IHHXPERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.]1
FORMALDEHYDEINACTIVE INGREDIENT1HG84L3525PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSPERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEPERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UPERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-159PERMETHRIN CREAM [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 2 package rows20120217_0494e7d2-70a5-44e5-a026-559fdf1808dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106387permethrin 5 % Topical CreamPSN0494e7d2-70a5-44e5-a026-559fdf1808dd1
106387permethrin 50 MG/ML Topical CreamSCD0494e7d2-70a5-44e5-a026-559fdf1808dd1
106387permethrin 5 % Topical CreamSY0494e7d2-70a5-44e5-a026-559fdf1808dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-159-065295901590660 g in 1 TUBE60 gHistorical