Nix Complete Lice Treatment

Product NDC: 63736-035
11-digit product format: 637360035
Labeler code: 63736
Product ID: 63736-035_47728f4a-f871-4adc-8c19-8af32c43635d
Type: HUMAN OTC DRUG
Nonproprietary name: Permethrin
Dosage form: KIT
Labeler: Insight Pharmaceuticals LLC
Application: NDA019918
Marketing category: NDA
Marketing start: 2013-11-15
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019918-001	NIX	PERMETHRIN	1%	LOTION / TOPICAL		RLD, RS	1990-05-02

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019918-001	NIX	1%	LOTION / TOPICAL	RLD, RS	1990-05-02	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nix Complete Lice Treatment
Listing expiration: 2026-12-31

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cca42777-01bf-4352-acdb-441160d69557	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f33e3e13-1328-47a9-3012-134a14fcb6a1	Product name	2	20190703

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63736-035-01	Nix Complete Lice Treatment	1 in 1 CARTON	KIT	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63736-035	NIX COMPLETE LICE TREATMENT (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS LLC]	2	Current NDC, Legacy NDC, 1 package rows	20200424_cca42777-01bf-4352-acdb-441160d69557.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nix Complete Lice Treatment	PERMETHRIN	Insight Pharmaceuticals LLC	cca42777-01bf-4352-acdb-441160d69557	2025-10-23	Warnings	Exact identifier application applno (NDA): 019918 application number: NDA019918 ndc (product): 63736-035
Nix	PERMETHRIN	Insight Pharmaceuticals LLC	d6dfa64a-bb88-4438-b4e2-30c6fbb28f3e	2025-10-23	Warnings	Exact identifier application applno (NDA): 019918 application number: NDA019918
Nix Lice Killing Creme Rinse	PERMETHRIN	Geodis Logistics LLC	cf7c2429-9ae0-4435-b695-aafd5f207d27	2022-02-07	Warnings	Exact identifier application applno (NDA): 019918 application number: NDA019918

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
509F88P9SZ	PERMETHRIN	52645-53-1	Permethrin

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63736-035-01	63736003501	1 KIT in 1 CARTON (63736-035-01) * 1 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 147.86 mL in 1 BOTTLE * 2 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE	1 kit	2013-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nix Complete Lice Treatment Kit	Insight Pharmaceuticals LLC	2025-10-23	HUMAN OTC DRUG LABEL	3
Nix COMPLETE Lice Treatment Kit	Geodis Logistics LLC	2022-02-07	HUMAN OTC DRUG LABEL	2