Bldaxn Ivermectin Lotion0.5%

Product NDC
84558-024
11-digit product format
845580024
Labeler code
84558
Product ID
84558-024_5679e6f5-1ee9-ee46-e063-6394a90a8d64
Type
HUMAN OTC DRUG
Nonproprietary name
Bldaxn Ivermectin Lotion 0.5%
Dosage form
EMULSION
Route
TOPICAL
Labeler
GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd
Application
M031
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-14
Substance
IVERMECTIN
Active strength
.5 g/100mL
Pharmacologic classes
Antiparasitic [EPC], Pediculicide [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Bldaxn Ivermectin Lotion0.5%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IVERMECTIN.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8883YP2R6DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1246673Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5679e6f5-1ee8-ee46-e063-6394a90a8d64Available on FDA.report

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 3 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foster and Thrive Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTStrategic Sourcing Services, LLC0b53591f-6181-b75a-e063-6294a90a49e32023-11-29WarningsExact identifier
application number: M031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84558-024-0184558002401140 mL in 1 BOX (84558-024-01) 140 ml2026-07-14NoNoCurrent