FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiLWK91TU9AH, ZUM06L90GV
Rxcui1372905

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