Nix

Product NDC: 76413-358
11-digit product format: 764130358
Labeler code: 76413
Product ID: 76413-358_94262aba-87d5-495c-997e-9380d95f2787
Type: HUMAN OTC DRUG
Nonproprietary name: Permethrin
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Central Texas Community Health Centers
Application: NDA019918
Marketing category: NDA
Marketing start: 2013-11-15
Marketing end: 0000-00-00
Substance: PERMETHRIN
Active strength: 1 g/100mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	76413-358		I	Inactivated by FDA		2026-08-07
excluded package	package	76413-358	76413-358-01	I	Inactivated by FDA		2026-08-07

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76413-358-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76413-358-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76413-358-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76413-358-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76413-358-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76413-358-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76413-358-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76413-358-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76413-358-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76413-358-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76413-358-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76413-358-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76413-358-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76413-358-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76413-358-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76413-358-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76413-358-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76413-358-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	76413-358-01	`8dfbde2a14a4…`	`c9ff85d89658…`

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…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76413-358-01	2021-01-29	C162847	48780-1	ba0f9c33-4ce8-a910-e053-dadaa90a0b85	NIX®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76413-358-01	Nix	1 mL in 1 CARTON	SHAMPOO	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76413-358	NIX (PERMETHRIN) SHAMPOO [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]	2	Legacy NDC, 1 package rows	20190116_ad967f76-6fda-4ac9-a71f-d0603a6ed71e.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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
763066	Nix Cream Rinse 1 % Medicated Shampoo	PSN	ad967f76-6fda-4ac9-a71f-d0603a6ed71e	2
250387	permethrin 1 % Medicated Shampoo	PSN	ad967f76-6fda-4ac9-a71f-d0603a6ed71e	2
763066	permethrin 10 MG/ML Medicated Shampoo [Nix Cream Rinse]	SBD	ad967f76-6fda-4ac9-a71f-d0603a6ed71e	2
250387	permethrin 10 MG/ML Medicated Shampoo	SCD	ad967f76-6fda-4ac9-a71f-d0603a6ed71e	2
763066	Nix Cream Rinse 1 % Medicated Shampoo	SY	ad967f76-6fda-4ac9-a71f-d0603a6ed71e	2
763066	Nix Cream Rinse 10 MG/ML Medicated Shampoo	SY	ad967f76-6fda-4ac9-a71f-d0603a6ed71e	2
250387	permethrin 1 % Medicated Shampoo	SY	ad967f76-6fda-4ac9-a71f-d0603a6ed71e	2
250387	permethrin 1 % Topical Lotion	SY	ad967f76-6fda-4ac9-a71f-d0603a6ed71e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
76413-358-01	76413035801	1 mL in 1 CARTON	1 ml	Historical

Nix