FDA.reportPublic FDA data

Herklin Lice Treatment

Product NDC
75940-192
11-digit product format
759400192
Labeler code
75940
Product ID
75940-192_3fbdf14a-eb00-4fd1-b00e-01f8354f04cb
Type
HUMAN OTC DRUG
Nonproprietary name
Piperonyl butoxide, Pyrethrum extract
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
MarcasUSA LLC
Application
part358G
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-07-16
Substance
PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT
Active strength
4; .33 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
Herklin Lice Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIPERONYL BUTOXIDE4 g/100mL
PYRETHRUM EXTRACT.33 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283219Internal RxNorm lookup
1988409Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
018e8b94-b52b-466c-8265-51fb68a67bcfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75940-192-09Herklin Lice Treatment59 mL in 1 BOTTLESHAMPOO591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75940-192HERKLIN LICE TREATMENT (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [MARCASUSA LLC]1Current NDC, Legacy NDC, 1 package rows20180717_018e8b94-b52b-466c-8265-51fb68a67bcf.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Herklin Lice TreatmentPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTMarcasUSA LLC018e8b94-b52b-466c-8265-51fb68a67bcf2018-07-16WarningsExact identifier
ndc (product): 75940-192

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1988409Herklin 4 % / 0.33 % Medicated ShampooPSN018e8b94-b52b-466c-8265-51fb68a67bcf1
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooPSN018e8b94-b52b-466c-8265-51fb68a67bcf1
1988409piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated Shampoo [Herklin]SBD018e8b94-b52b-466c-8265-51fb68a67bcf1
283219piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated ShampooSCD018e8b94-b52b-466c-8265-51fb68a67bcf1
1988409Herklin (piperonyl butoxide 4 % / pyrethrins 0.33 % ) Medicated ShampooSY018e8b94-b52b-466c-8265-51fb68a67bcf1
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooSY018e8b94-b52b-466c-8265-51fb68a67bcf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75940-192-097594001920959 mL in 1 BOTTLE (75940-192-09) 59 ml2018-07-160000-00-00NoNoCurrent