Nix Complete Maximum Strength Lice Elimination

Product NDC
63736-027
11-digit product format
637360027
Labeler code
63736
Product ID
63736-027_28160f0d-9f01-4377-a0d7-0b24f9fb86c9
Type
HUMAN OTC DRUG
Nonproprietary name
Permethrin
Dosage form
KIT
Labeler
Insight Pharmaceuticals LLC
Application
NDA019918
Marketing category
NDA
Marketing start
2013-11-15
Marketing end
2023-06-30
Active strength
0
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63736-027DDiscontinued by firm2026-08-11
excluded packagepackage63736-02763736-027-06DDiscontinued 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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63736-027-06DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63736-027-06DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63736-027-06DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63736-027-06DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63736-027-06DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63736-027-06DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63736-027-06DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63736-027-06DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63736-027-06DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63736-027-06DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63736-027-06DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63736-027-06DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63736-027-06IInactivated 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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63736-027-062020-06-29C16284748780-19d75b9d0-7dce-f424-e053-dadaa90a57ceNix Complete Lice Treatment Kit
63736-027-062020-01-31C16284748780-19d75b9d0-7dce-f424-e053-dadaa90a57ceNix Complete Lice Treatment Kit

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PermethrinACTIVE INGREDIENT509F88P9SZNIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
PermethrinACTIVE MOIETY509F88P9SZNIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [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 COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [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
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
stearalkonium chlorideINACTIVE INGREDIENT0OUO26BB88NIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1
waterINACTIVE INGREDIENT059QF0KO0RNIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]1

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-027-06637360027061 KIT in 1 CARTON (63736-027-06) * 59 mL in 1 BOTTLE * 59 mL in 1 BOTTLE1 kit2013-11-152023-06-30NoNoCurrent