FDA.reportPublic FDA data

Application 019918

Type
NDA
Sponsor
MEDTECH PRODUCTS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIXPERMETHRINLOTION;TOPICAL1%YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02a50c72e98297…

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
ndc (product): 63736-035
NixPERMETHRINInsight Pharmaceuticals LLCd6dfa64a-bb88-4438-b4e2-30c6fbb28f3e2025-10-23WarningsExact identifier
application applno (NDA): 019918
application number: NDA019918
ndc (product): 63736-030
Nix Lice Killing Creme RinsePERMETHRINGeodis Logistics LLCcf7c2429-9ae0-4435-b695-aafd5f207d272022-02-07WarningsExact identifier
application applno (NDA): 019918
application number: NDA019918
ndc (product): 63471-3006

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63471-3006Nix Lice Killing Creme RinsePERMETHRINGeodis Logistics LLCNDACurrent
63471-3010Nix FAMILY PACK Lice Killing Creme Rinse KitPERMETHRINGeodis Logistics LLCNDACurrent
63471-3020Nix COMPLETE Lice TreatmentPERMETHRINGeodis Logistics LLCNDACurrent
63736-024NixPermethrinInsight PharmaceuticalsNDACurrent
63736-024NixPermethrinInsight Pharmaceuticals LLCNDACurrent
63736-024NixPermethrinInsight Pharmaceuticals LLCNDACurrent
63736-027Nix Complete Maximum Strength Lice EliminationPermethrinInsight Pharmaceuticals LLCNDACurrent
63736-027Nix Complete Maximum Strength Lice EliminationPermethrinInsight Pharmaceuticals LLCNDACurrent
63736-030NixPermethrinInsight Pharmaceuticals LLCNDACurrent
63736-030NixPermethrinInsight Pharmaceuticals LLCNDACurrent
63736-035Nix Complete Lice TreatmentPermethrinInsight Pharmaceuticals LLCNDACurrent
76413-358NixPermethrinCentral Texas Community Health CentersNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
1812SUPPL2002-01-17
20423SUPPL1997-12-11