U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
Spinosad is a natural mixture of pediculicidal tetracyclic macrolides—spinosyn A and spinosyn D in the ratio of 5:1. It is derived from species of actinomycetes bacteria - Saccharopolyspora spinosa and is a bacterial waste product produced by fermentation on a nutrient food source. It has since long been used as a pesticide and classified by the US Environment Protection Agency as a reduced risk pesticide product. Spinosad has a high level of efficacy for lepidopteran larvae, as well as some Diptera, Coleoptera, Thysanoptera, and Hymenoptera, but has limited to no activity to other insects and exhibits low toxicity to mammals and other wildlife. Spinosad overstimulates nerve cells by prolonging electrical impulse across synapses by acting like acetylcholine. After periods of hyperexcitation, lice become paralyzed and die. Recently, FDA has approved the topical suspension of spinosad 0.9% for treatment of head lice infestation in patients four years of age and older. It is both pediculicidal and ovicidal.

Approval Year

Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
NATROBA

Approved Use

Spinosad Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in patients four (4) years of age and older.

Launch Date

2011

Sample Use Guides

Natroba (spinosad) topical suspension, 0.9% is indicated for the topical treatment of head lice infestations in patients four years of age and older. Apply product to dry scalp and hair using only the amount needed to cover the scalp and hair. Rinse off with warm water after 10 minutes. Repeat treatment if live lice are seen 7 days after first treatment.
Route of Administration: Irrigation
Substance Class Mixture
Created
by admin
on Fri Dec 15 15:49:38 GMT 2023
Edited
by admin
on Fri Dec 15 15:49:38 GMT 2023
Record UNII
XPA88EAP6V
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
SPINOSAD
DASH   GREEN BOOK   ORANGE BOOK   USAN   VANDF   WHO-DD  
USAN  
Official Name English
COMFORTIS
Brand Name English
SUCCESS
Brand Name English
NATURALYTE
Brand Name English
JUSTICE
Brand Name English
SPINOSAD COMPONENT OF TRIFEXIS
Brand Name English
NATROVA
Brand Name English
SPINOSAD [USAN]
Common Name English
TRACER
Brand Name English
XDE-105
Code English
SPINOSAD [ISO]
Common Name English
Spinosad [WHO-DD]
Common Name English
SPINOSAD (EMA EPAR: VETERINARY)
Common Name English
SPINOSYNS SPINOSAD [MI]
Common Name English
BLACKHAWK
Brand Name English
DE-105
Code English
LY-232105
Code English
EXTINOSAD
Brand Name English
NATROBA
Brand Name English
CONSERVE
Brand Name English
TRIFEXIS COMPONENT SPINOSAD
Brand Name English
MIXTURE OF SPINOSAD FACTOR A AND SPINOSAD FACTOR D
Common Name English
ENTRUST
Brand Name English
SPINOSAD [ORANGE BOOK]
Common Name English
PP-105
Code English
SPINTOR
Brand Name English
SPINOSAD [VANDF]
Common Name English
SPINOSAD [GREEN BOOK]
Common Name English
SPINOSAD [MI]
Common Name English
Classification Tree Code System Code
NDF-RT N0000181811
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
CFR 21 CFR 520.2130
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
EMA VETERINARY ASSESSMENT REPORTS TRIFEXIS [AUTHORIZED]
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
EPA PESTICIDE CODE 110003
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
EMA VETERINARY ASSESSMENT REPORTS COMFORTIS (AUTHORISED)
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
EMA VETERINARY ASSESSMENT REPORTS COMFORTIS (AUTHORISED)
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
CFR 21 CFR 520.2134
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
WHO-VATC QP53BX03
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
Code System Code Type Description
MERCK INDEX
m10147
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
PRIMARY
USAN
UU-41
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PRIMARY
CHEBI
39211
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PRIMARY
DAILYMED
XPA88EAP6V
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PRIMARY
DRUG BANK
DB08823
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PRIMARY
RXCUI
299081
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PRIMARY RxNorm
WIKIPEDIA
SPINOSAD
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PRIMARY
CHEBI
35204
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PRIMARY
MESH
C415329
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
PRIMARY
ALANWOOD
spinosad
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
PRIMARY
EPA CompTox
DTXSID7032478
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
PRIMARY
DRUG CENTRAL
4623
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PRIMARY
ChEMBL
CHEMBL2040681
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PRIMARY
NCI_THESAURUS
C170381
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
PRIMARY
CAS
168316-95-8
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
PRIMARY
FDA UNII
XPA88EAP6V
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
PRIMARY
LACTMED
Spinosad
Created by admin on Fri Dec 15 15:49:38 GMT 2023 , Edited by admin on Fri Dec 15 15:49:38 GMT 2023
PRIMARY
All of the following components must be present:
Related Record Type Details
ACTIVE MOIETY
Definition References