FDA.reportPublic FDA data

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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTMeijer, Inc.0191bc62-aa7c-874a-e063-6294a90a95b92024-12-19WarningsExact identifier
application number: M031
Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTWeeks & Leo Co., Inc.c3647aca-7fb9-e2f4-e053-2995a90a7acb2024-12-13WarningsExact identifier
application number: M031
GoodSense Complete Lice Treatment KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTPerrigo Direct, LLC0c03564e-d9db-d148-e063-6394a90a7d7f2024-12-13WarningsExact identifier
application number: M031
Kroger Complete Lice Treatment KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTThe Kroger Co0c0308c9-72d2-d29b-e063-6294a90a6ef52024-12-13WarningsExact identifier
application number: M031
Quality Choice Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTQuality Choice291b45a4-0527-79e4-e063-6294a90aa47a2024-12-12WarningsExact identifier
application number: M031
El Piojito Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTPharmadel487f72e0-e2c6-32ea-e054-00144ff8d46c2024-12-12WarningsExact identifier
application number: M031
RID Lice KillingPIPERONYL BUTOXIDE AND PYRETHRUM EXTRACTOystershell Consumer Health Inc55102839-05f2-41ac-a20e-1b2d7a3f4be62023-12-20WarningsExact identifier
application number: M031
Discount Lice TreatmentPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTDiscount drug mart88ede7e6-82d6-db8a-e053-2a95a90a00be2023-12-12WarningsExact identifier
application number: M031
Best Choice Lice TreatmentPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTAssociated Wholesale Grocers, Inc.89019cc4-9ff4-3fd5-e053-2a95a90a31252023-12-09WarningsExact identifier
application number: M031
Weeks and Leo Complete Lice TreatmentPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTWeeks & Leo Co., Inc.499bdb9f-c235-3293-e054-00144ff8d46c2023-12-09WarningsExact identifier
application number: M031
CVS 3 Step Lice SolutionPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTCVS49cd21fc-282e-103b-e054-00144ff88e882023-12-08WarningsExact identifier
application number: M031
CVS 3 Step Lice SolutionPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTCVS82e11c44-3802-d680-e053-2991aa0a991c2023-12-08WarningsExact identifier
application number: M031
Kroger Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTThe Kroger Co0bf17178-c33f-d6fb-e063-6294a90a884a2023-12-07WarningsExact identifier
application number: M031
Discount Drug Mart Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTDiscount Drug Mart480b334d-c212-0045-e054-00144ff88e882023-12-07WarningsExact identifier
application number: M031
Walgreens Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTWalgreens CO82bbdd69-1ad1-ec84-e053-2991aa0a15fc2023-12-07WarningsExact identifier
application number: M031
Family Wellness Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTFamily Dollar0be00786-d700-4082-e063-6294a90a4f872023-12-06WarningsExact identifier
application number: M031
Topcare Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTTopco Associates, LLC0be04816-e173-8046-e063-6294a90acdb62023-12-06WarningsExact identifier
application number: M031
Major Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTMajor Pharmaceuticals0bc94e0e-6772-425e-e063-6394a90a6bf12023-12-05WarningsExact identifier
application number: M031
GNP Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTAmerisourceBergen Drug Corporation0bc99cab-0996-55ee-e063-6294a90a3dc52023-12-05WarningsExact identifier
application number: M031
Rite Aid Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTRite Aid Corp0bca8a15-ed57-ab4b-e063-6394a90ae3db2023-12-05WarningsExact 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