LIENDREX

Product NDC: 53145-308
11-digit product format: 531450308
Labeler code: 53145
Product ID: 53145-308_3a8ad090-e1c5-7ea7-e063-6394a90a6ffc
Type: HUMAN OTC DRUG
Nonproprietary name: Pyrethrum extract, Piperonyl Butoxide
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Menper Distributors Inc.
Application: M031
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-01-01
Substance: PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT
Active strength: 4; .3 g/100mL; g/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53145-308-04	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53145-308-04	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53145-308-04	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53145-308-04	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53145-308-04	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53145-308-04	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53145-308-04	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: LIENDREX
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PIPERONYL BUTOXIDE	4 g/100mL
PYRETHRUM EXTRACT	.3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LWK91TU9AH	Internal UNII lookup
ZUM06L90GV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1372905	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
65f86a0d-0cf7-42f6-84de-4dc9e7791aba	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53145-308-04	2020-01-31	C162847	48780-1	9d75b9d0-df5a-f424-e053-dadaa90a57ce	Liendrex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53145-308-04	LIENDREX	120 mL in 1 BOTTLE	SHAMPOO	120		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PIPERONYL BUTOXIDE	ACTIVE INGREDIENT	LWK91TU9AH	LIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]	1
PYRETHRUM EXTRACT	ACTIVE INGREDIENT	ZUM06L90GV	LIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]	1
PIPERONYL BUTOXIDE	ACTIVE MOIETY	LWK91TU9AH	LIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]	1
PYRETHRUM EXTRACT	ACTIVE MOIETY	ZUM06L90GV	LIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	LIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	LIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	LIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]	1
PEG-20 SORBITAN ISOSTEARATE	INACTIVE INGREDIENT	X958PZJ9ON	LIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]	1
SODIUM LAURETH-13 CARBOXYLATE	INACTIVE INGREDIENT	795TQP1655	LIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]	1
SODIUM LAUROAMPHOACETATE	INACTIVE INGREDIENT	SLK428451L	LIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]	1
SODIUM TRIDECETH SULFATE	INACTIVE INGREDIENT	E827ILX331	LIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]	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 2 of 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GoodSense Complete Lice Treatment Kit	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	Perrigo Direct, LLC	0c03564e-d9db-d148-e063-6394a90a7d7f	2024-12-13	Warnings	Exact identifier application number: M031
Kroger Complete Lice Treatment Kit	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	The Kroger Co	0c0308c9-72d2-d29b-e063-6294a90a6ef5	2024-12-13	Warnings	Exact identifier application number: M031
Quality Choice Lice Killing	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	Quality Choice	291b45a4-0527-79e4-e063-6294a90aa47a	2024-12-12	Warnings	Exact identifier application number: M031
El Piojito Lice Killing	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	Pharmadel	487f72e0-e2c6-32ea-e054-00144ff8d46c	2024-12-12	Warnings	Exact identifier application number: M031
RID Lice Killing	PIPERONYL BUTOXIDE AND PYRETHRUM EXTRACT	Oystershell Consumer Health Inc	55102839-05f2-41ac-a20e-1b2d7a3f4be6	2023-12-20	Warnings	Exact identifier application number: M031
Discount Lice Treatment	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	Discount drug mart	88ede7e6-82d6-db8a-e053-2a95a90a00be	2023-12-12	Warnings	Exact identifier application number: M031
Best Choice Lice Treatment	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	Associated Wholesale Grocers, Inc.	89019cc4-9ff4-3fd5-e053-2a95a90a3125	2023-12-09	Warnings	Exact identifier application number: M031
Weeks and Leo Complete Lice Treatment	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	Weeks & Leo Co., Inc.	499bdb9f-c235-3293-e054-00144ff8d46c	2023-12-09	Warnings	Exact identifier application number: M031
CVS 3 Step Lice Solution	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	CVS	49cd21fc-282e-103b-e054-00144ff88e88	2023-12-08	Warnings	Exact identifier application number: M031
CVS 3 Step Lice Solution	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	CVS	82e11c44-3802-d680-e053-2991aa0a991c	2023-12-08	Warnings	Exact identifier application number: M031
Kroger Lice Killing	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	The Kroger Co	0bf17178-c33f-d6fb-e063-6294a90a884a	2023-12-07	Warnings	Exact identifier application number: M031
Discount Drug Mart Lice Killing	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	Discount Drug Mart	480b334d-c212-0045-e054-00144ff88e88	2023-12-07	Warnings	Exact identifier application number: M031
Walgreens Lice Killing	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	Walgreens CO	82bbdd69-1ad1-ec84-e053-2991aa0a15fc	2023-12-07	Warnings	Exact identifier application number: M031
Family Wellness Lice Killing	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	Family Dollar	0be00786-d700-4082-e063-6294a90a4f87	2023-12-06	Warnings	Exact identifier application number: M031
Topcare Lice Killing	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	Topco Associates, LLC	0be04816-e173-8046-e063-6294a90acdb6	2023-12-06	Warnings	Exact identifier application number: M031
Major Lice Killing	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	Major Pharmaceuticals	0bc94e0e-6772-425e-e063-6394a90a6bf1	2023-12-05	Warnings	Exact identifier application number: M031
GNP Lice Killing	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	AmerisourceBergen Drug Corporation	0bc99cab-0996-55ee-e063-6294a90a3dc5	2023-12-05	Warnings	Exact identifier application number: M031
Rite Aid Lice Killing	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	Rite Aid Corp	0bca8a15-ed57-ab4b-e063-6394a90ae3db	2023-12-05	Warnings	Exact identifier application number: M031
Foster and Thrive Lice Killing	PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT	Strategic Sourcing Services, LLC	0b53591f-6181-b75a-e063-6294a90a49e3	2023-11-29	Warnings	Exact identifier application number: M031

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LWK91TU9AH	PIPERONYL BUTOXIDE	51-03-6	PIPERONYL BUTOXIDE
ZUM06L90GV	PYRETHRUM EXTRACT	8003-34-7	PYRETHRUM EXTRACT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1372905	piperonyl butoxide 4 % / pyrethrins 0.3 % Medicated Shampoo	PSN	65f86a0d-0cf7-42f6-84de-4dc9e7791aba	3
1372905	piperonyl butoxide 40 MG/ML / pyrethrins 3 MG/ML Medicated Shampoo	SCD	65f86a0d-0cf7-42f6-84de-4dc9e7791aba	3
1372905	piperonyl butoxide 4 % / pyrethrins 0.3 % Medicated Shampoo	SY	65f86a0d-0cf7-42f6-84de-4dc9e7791aba	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
53145-308-04	53145030804	120 mL in 1 BOTTLE (53145-308-04)	120 ml	2013-01-01	No	No	Current