leader lice treatment

Product NDC: 49781-028
Requested package NDC: 49781-028-02
11-digit product format: 497810028
Labeler code: 49781
Product ID: 49781-028_7aa1dc2f-62dc-4fc2-9a9a-4f3925f984a0
Type: HUMAN OTC DRUG
Nonproprietary name: Permethrin
Dosage form: LOTION
Route: TOPICAL
Labeler: Cardinal Health
Application: ANDA076090
Marketing category: ANDA
Marketing start: 2011-06-15
Marketing end: 2021-03-01
Substance: PERMETHRIN
Active strength: 1 mg/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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	49781-028	49781-028-02	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A076090-001	PERMETHRIN	PERMETHRIN	1%	LOTION / TOPICAL			2001-12-20

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076090-001	PERMETHRIN	1%	LOTION / TOPICAL	2001-12-20	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49781-028-02	ML - Milliliter	49781-028	eea1f329-1fd0-45cd-8998-9797ad13f411	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PERMETHRIN	ACTIVE INGREDIENT	509F88P9SZ	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	1
PERMETHRIN	ACTIVE MOIETY	509F88P9SZ	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	1
BALSAM FIR LEAFY TWIG	INACTIVE INGREDIENT	H1TFV1454Z	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	1
CETETH-10	INACTIVE INGREDIENT	LF9X1PN3XJ	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	1
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	1
STEARALKONIUM CHLORIDE	INACTIVE INGREDIENT	0OUO26BB88	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LEADER LICE TREATMENT (PERMETHRIN) LOTION [CARDINAL HEALTH]	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense lice killing creme rinse	PERMETHRIN	L. Perrigo Company	056fb377-34dd-4d33-83d7-c895b105f574	2022-11-21	Warnings	Exact identifier application applno (ANDA): 076090 application number: ANDA076090
Topcare lice killing creme rinse	PERMETHRIN	Topco Associates LLC	3b4146a6-7c54-4dd0-9388-1e38491d16f3	2020-01-31	Warnings	Exact identifier application applno (ANDA): 076090 application number: ANDA076090

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
49781-028-02	49781002802	1 BOTTLE in 1 CARTON (49781-028-02) > 59 mL in 1 BOTTLE	1 bottle	2011-06-15	2021-03-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cardinal Health Lice Treatment Creme Rinse Drug Facts	Cardinal Health	2020-12-03	HUMAN OTC DRUG LABEL	3