FDA.reportPublic FDA data

LIENDREX

Product NDC
53145-308
Requested package NDC
53145-308-04
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 44 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 dedicatedIVERMETShenzhen Zhenshangzekai Technology Co., Ltd.459aafa5-08d4-3667-e063-6294a90a3b942025-12-12WarningsExact 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 (package): 53145-308-04
ndc (product): 53145-308
ndc11 (package): 53145030804
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

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

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