FDA.reportPublic FDA data

Nix

Product NDC
63736-024
11-digit product format
637360024
Labeler code
63736
Product ID
63736-024_9709532d-7e89-453b-a1c2-bfd4d02c1406
Type
HUMAN OTC DRUG
Nonproprietary name
Permethrin
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Insight Pharmaceuticals LLC
Application
NDA019918
Marketing category
NDA
Marketing start
2013-11-15
Marketing end
2023-06-30
Substance
PERMETHRIN
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f33e3e13-1328-47a9-3012-134a14fcb6a1Product name220190703

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63736-024-022020-06-30C16284748780-19d75b9d0-aa2c-f424-e053-dadaa90a57ce3d757b15-0bae-45c1-8fae-6ebdf0f7d560
63736-024-042020-06-30C16284748780-19d75b9d0-aa2c-f424-e053-dadaa90a57ce3d757b15-0bae-45c1-8fae-6ebdf0f7d560
63736-024-022020-01-31C16284748780-19d75b9d0-aa2c-f424-e053-dadaa90a57ce3d757b15-0bae-45c1-8fae-6ebdf0f7d560
63736-024-042020-01-31C16284748780-19d75b9d0-aa2c-f424-e053-dadaa90a57ce3d757b15-0bae-45c1-8fae-6ebdf0f7d560
63736-024-032019-10-21C16284748780-1956f9ecf-cd2c-621f-e053-dbdaa90a74adNix ® Lice Killing Creme Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-024-03Nix59 mL in 1 BOTTLESHAMPOO591
63736-024-03Nix1 in 1 CARTONSHAMPOO11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63736-024-03ML - Milliliter63736-024edae0d8b-ee49-4c7a-9d75-27b6627413e912017-10-13
63736-024-04ML - Milliliter63736-024dadced74-ab25-4fa4-af43-6eae607d479e12019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PermethrinACTIVE INGREDIENT509F88P9SZNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
PermethrinACTIVE MOIETY509F88P9SZNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
Cetyl alcoholINACTIVE INGREDIENT936JST6JCNNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8NIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302NIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
stearalkonium chlorideINACTIVE INGREDIENT0OUO26BB88NIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
waterINACTIVE INGREDIENT059QF0KO0RNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-024NIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1Legacy NDC, 2 package rows20090629_8bc95ef1-ea25-4ae7-a6e4-57e3e300a2c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763066Nix Cream Rinse 1 % Medicated ShampooPSNad967f76-6fda-4ac9-a71f-d0603a6ed71e2
250387permethrin 1 % Medicated ShampooPSNad967f76-6fda-4ac9-a71f-d0603a6ed71e2
763066permethrin 10 MG/ML Medicated Shampoo [Nix Cream Rinse]SBDad967f76-6fda-4ac9-a71f-d0603a6ed71e2
250387permethrin 10 MG/ML Medicated ShampooSCDad967f76-6fda-4ac9-a71f-d0603a6ed71e2
763066Nix Cream Rinse 1 % Medicated ShampooSYad967f76-6fda-4ac9-a71f-d0603a6ed71e2
763066Nix Cream Rinse 10 MG/ML Medicated ShampooSYad967f76-6fda-4ac9-a71f-d0603a6ed71e2
250387permethrin 1 % Medicated ShampooSYad967f76-6fda-4ac9-a71f-d0603a6ed71e2
250387permethrin 1 % Topical LotionSYad967f76-6fda-4ac9-a71f-d0603a6ed71e2
763066Nix Cream Rinse 1 % Medicated ShampooPSN8bc95ef1-ea25-4ae7-a6e4-57e3e300a2c11
250387permethrin 1 % Medicated ShampooPSN8bc95ef1-ea25-4ae7-a6e4-57e3e300a2c11
763066permethrin 10 MG/ML Medicated Shampoo [Nix Cream Rinse]SBD8bc95ef1-ea25-4ae7-a6e4-57e3e300a2c11
250387permethrin 10 MG/ML Medicated ShampooSCD8bc95ef1-ea25-4ae7-a6e4-57e3e300a2c11
763066Nix Cream Rinse 1 % Medicated ShampooSY8bc95ef1-ea25-4ae7-a6e4-57e3e300a2c11
763066Nix Cream Rinse 10 MG/ML Medicated ShampooSY8bc95ef1-ea25-4ae7-a6e4-57e3e300a2c11
250387permethrin 1 % Medicated ShampooSY8bc95ef1-ea25-4ae7-a6e4-57e3e300a2c11
250387permethrin 1 % Topical LotionSY8bc95ef1-ea25-4ae7-a6e4-57e3e300a2c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-024-02637360024021 BOTTLE in 1 CARTON (63736-024-02) > 59 mL in 1 BOTTLE1 bottle2013-11-152023-06-30NoNoCurrent
63736-024-036373600240359 mL in 1 BOTTLE59 mlHistorical
63736-024-04637360024042 BOTTLE in 1 CARTON (63736-024-04) > 59 mL in 1 BOTTLE2 bottle2013-11-152023-06-30NoNoCurrent