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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53145-308-04IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53145-308-04IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53145-308-04IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53145-308-04IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53145-308-04IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53145-308-04IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53145-308-04EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIPERONYL BUTOXIDE4 g/100mL
PYRETHRUM EXTRACT.3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LWK91TU9AHInternal UNII lookup
ZUM06L90GVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
65f86a0d-0cf7-42f6-84de-4dc9e7791abaAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-308-042020-01-31C16284748780-19d75b9d0-df5a-f424-e053-dadaa90a57ceLiendrex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-308-04LIENDREX120 mL in 1 BOTTLESHAMPOO1203

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIPERONYL BUTOXIDEACTIVE INGREDIENTLWK91TU9AHLIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]1
PYRETHRUM EXTRACTACTIVE INGREDIENTZUM06L90GVLIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]1
PIPERONYL BUTOXIDEACTIVE MOIETYLWK91TU9AHLIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]1
PYRETHRUM EXTRACTACTIVE MOIETYZUM06L90GVLIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXLIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LULIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]1
PEG-20 SORBITAN ISOSTEARATEINACTIVE INGREDIENTX958PZJ9ONLIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]1
SODIUM LAURETH-13 CARBOXYLATEINACTIVE INGREDIENT795TQP1655LIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]1
SODIUM LAUROAMPHOACETATEINACTIVE INGREDIENTSLK428451LLIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]1
SODIUM TRIDECETH SULFATEINACTIVE INGREDIENTE827ILX331LIENDREX (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [MENPER DISTRIBUTORS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLIENDREX (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 1 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bldaxn Ivermectin Lotion0.5%BLDAXN IVERMECTIN LOTION 0.5%GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5679e6f5-1ee8-ee46-e063-6394a90a8d642026-07-13WarningsExact identifier
application number: M031
RID Lice Treatment Complete KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTOystershell Consumer Health Inc6fd3531a-3d51-4251-89db-808c9f75e4ea2026-06-25WarningsExact identifier
application number: M031
Kakshal PermethrinPERMETHRINKakshal4ddc2aef-daef-13a9-e063-6394a90af3e32026-05-08WarningsExact identifier
application number: M031
lice treatment dedicatedIVERMECTINShenzhen Zhenshangzekai Technology Co., Ltd.459879fb-efd1-9fc1-e063-6394a90a98b02025-12-10WarningsExact identifier
application number: M031
ivometn ivermectin lice treatmentIVERMECTINShenzhen Zhenshangzekai Technology Co., Ltd.459b4316-89df-0bb1-e063-6294a90a518d2025-12-10WarningsExact identifier
application number: M031
VanalicePIPERONYL BUTOXIDE, PYRETHRUMGM Pharmaceuticals, INCc0205fa6-c8f4-4a28-9341-56a1208437062025-12-03WarningsExact identifier
application number: M031
Quality Choice Lice TreatmentPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTChain Drug Marketing Association1f4392ba-f405-7ee1-e063-6394a90ae6312025-11-12WarningsExact identifier
application number: M031
Topcare Complete Lice Treatment KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTTopco Associates, LLC0bf3980f-d10d-afc9-e063-6294a90acbf52025-11-11WarningsExact identifier
application number: M031
Leader Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTLEADER/ Cardinal Health 110, Inc.fea8ca80-2392-160f-e053-6294a90ae6fe2025-10-29WarningsExact identifier
application number: M031
ABC Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTWeeks & Leo Co., Inc.1046aa13-4dda-d5f8-e063-6394a90a714e2025-10-29WarningsExact identifier
application number: M031
GoodSense Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTPerrigo Direct, Inc.0bf1cdd7-7bdb-1aa0-e063-6294a90a517f2025-10-29WarningsExact identifier
application number: M031
Walgreens Lice EliminationPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTWalgreens8876272e-6bfd-6844-e053-2995a90a834f2025-10-29WarningsExact identifier
application number: M031
Premier Value Lice Treatment KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTPHARMACY VALUE ALLIANCE LLCb60b24a6-fdca-244f-e053-2a95a90a3c4d2025-10-29WarningsExact identifier
application number: M031
Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTPHARMACY VALUE ALLIANCE LLCb3dc154a-e341-5632-e053-2995a90affb22025-10-29WarningsExact identifier
application number: M031
Mata Piojos LicePIPERONYL BUTOXIDE, PYRETHRUM EXTRACTGRANDALL DISTRIBUTING, LLC1de4e361-4e7b-4f7e-b6c8-30fa21e75bea2025-10-27WarningsExact identifier
application number: M031
LIENDREXPYRETHRUM EXTRACT, PIPERONYL BUTOXIDEMenper Distributors Inc.65f86a0d-0cf7-42f6-84de-4dc9e7791aba2025-07-22WarningsExact identifier
application number: M031
ndc (product): 53145-308
Lice No More Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTWeeks & Leo Co., Inc372819f1-0817-2cd5-e063-6294a90ac5bf2025-06-09WarningsExact identifier
application number: M031
Rite Aid Complete Lice Elimination KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTRite Aid0bf40aa5-b931-663e-e063-6394a90a803f2025-01-07WarningsExact identifier
application number: M031
Quita Piojos Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTDLC Laboratories82ce4cf7-ea46-c838-e053-2991aa0a9c382024-12-23WarningsExact identifier
application number: M031
ZAP Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTDLC laboratories Inc.82d24cd9-6615-7901-e053-2991aa0ad1682024-12-23WarningsExact identifier
application number: M031

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372905piperonyl butoxide 4 % / pyrethrins 0.3 % Medicated ShampooPSN65f86a0d-0cf7-42f6-84de-4dc9e7791aba3
1372905piperonyl butoxide 40 MG/ML / pyrethrins 3 MG/ML Medicated ShampooSCD65f86a0d-0cf7-42f6-84de-4dc9e7791aba3
1372905piperonyl butoxide 4 % / pyrethrins 0.3 % Medicated ShampooSY65f86a0d-0cf7-42f6-84de-4dc9e7791aba3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53145-308-0453145030804120 mL in 1 BOTTLE (53145-308-04) 120 ml2013-01-01NoNoCurrent