Nix

Product NDC
63736-024
Requested package NDC
63736-024-04
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63736-02463736-024-04DDiscontinued by firm2026-08-11

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 · 13 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019918-001NIXPERMETHRIN1%LOTION / TOPICALRLD, RS1990-05-02

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0287673890dc5c…
2021-03-12 10:30 UTC2021-03N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-023f01610625f2…
2019-09-15 20:21 UTC2019-09N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02b00525d2431f…
2019-07-19 19:46 UTC2019-07N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-023f0d92c62455…
2023-05-13 08:27 UTC2023-05N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02053a50430f4f…
2023-01-26 05:58 UTC2023-01N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02cb3db0bc1861…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

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 COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
PermethrinACTIVE INGREDIENT509F88P9SZNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
PermethrinACTIVE INGREDIENT509F88P9SZNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
PermethrinACTIVE MOIETY509F88P9SZNIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
PermethrinACTIVE MOIETY509F88P9SZNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
PermethrinACTIVE MOIETY509F88P9SZNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLNIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
canada balsamINACTIVE INGREDIENTK304VI98I3NIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
ceteth-10INACTIVE INGREDIENTLF9X1PN3XJNIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
Cetyl alcoholINACTIVE INGREDIENT936JST6JCNNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNNIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
Cetyl alcoholINACTIVE INGREDIENT936JST6JCNNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPNIX (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
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8NIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8NIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302NIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302NIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302NIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3NIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
Stearalkonium chlorideINACTIVE INGREDIENT0OUO26BB88NIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
stearalkonium chlorideINACTIVE INGREDIENT0OUO26BB88NIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
stearalkonium chlorideINACTIVE INGREDIENT0OUO26BB88NIX (PERMETHRIN) SHAMPOO [INSIGHT PHARMACEUTICALS]1
waterINACTIVE INGREDIENT059QF0KO0RNIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
waterINACTIVE INGREDIENT059QF0KO0RNIX (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

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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nix Complete Lice TreatmentPERMETHRINInsight Pharmaceuticals LLCcca42777-01bf-4352-acdb-441160d695572025-10-23WarningsExact identifier
application applno (NDA): 019918
application number: NDA019918
NixPERMETHRINInsight Pharmaceuticals LLCd6dfa64a-bb88-4438-b4e2-30c6fbb28f3e2025-10-23WarningsExact identifier
application applno (NDA): 019918
application number: NDA019918
Nix Lice Killing Creme RinsePERMETHRINGeodis Logistics LLCcf7c2429-9ae0-4435-b695-aafd5f207d272022-02-07WarningsExact identifier
application applno (NDA): 019918
application number: NDA019918

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
63736-024-04637360024042 BOTTLE in 1 CARTON (63736-024-04) > 59 mL in 1 BOTTLE2 bottle2013-11-152023-06-30NoNoCurrent