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 1 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bldaxn Ivermectin Lotion0.5%BLDAXN IVERMECTIN LOTION 0.5%GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5679e6f5-1ee8-ee46-e063-6394a90a8d642026-07-13WarningsExact identifier
application number: M031
ndc (product): 84558-024
RID Lice Treatment Complete KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTOystershell Consumer Health Inc6fd3531a-3d51-4251-89db-808c9f75e4ea2026-06-25WarningsExact identifier
application number: M031
lice treatment dedicatedIVERMECTINShenzhen Zhenshangzekai Technology Co., Ltd.459879fb-efd1-9fc1-e063-6394a90a98b02025-12-10WarningsExact identifier
application number: M031
ivometn ivermectin lice treatmentIVERMECTINShenzhen Zhenshangzekai Technology Co., Ltd.459b4316-89df-0bb1-e063-6294a90a518d2025-12-10WarningsExact identifier
application number: M031
VanalicePIPERONYL BUTOXIDE, PYRETHRUMGM Pharmaceuticals, INCc0205fa6-c8f4-4a28-9341-56a1208437062025-12-03WarningsExact identifier
application number: M031
Quality Choice Lice TreatmentPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTChain Drug Marketing Association1f4392ba-f405-7ee1-e063-6394a90ae6312025-11-12WarningsExact identifier
application number: M031
Topcare Complete Lice Treatment KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTTopco Associates, LLC0bf3980f-d10d-afc9-e063-6294a90acbf52025-11-11WarningsExact identifier
application number: M031
Leader Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTLEADER/ Cardinal Health 110, Inc.fea8ca80-2392-160f-e053-6294a90ae6fe2025-10-29WarningsExact identifier
application number: M031
ABC Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTWeeks & Leo Co., Inc.1046aa13-4dda-d5f8-e063-6394a90a714e2025-10-29WarningsExact identifier
application number: M031
GoodSense Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTPerrigo Direct, Inc.0bf1cdd7-7bdb-1aa0-e063-6294a90a517f2025-10-29WarningsExact identifier
application number: M031
Walgreens Lice EliminationPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTWalgreens8876272e-6bfd-6844-e053-2995a90a834f2025-10-29WarningsExact identifier
application number: M031
Premier Value Lice Treatment KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTPHARMACY VALUE ALLIANCE LLCb60b24a6-fdca-244f-e053-2a95a90a3c4d2025-10-29WarningsExact identifier
application number: M031
Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTPHARMACY VALUE ALLIANCE LLCb3dc154a-e341-5632-e053-2995a90affb22025-10-29WarningsExact identifier
application number: M031
Mata Piojos LicePIPERONYL BUTOXIDE, PYRETHRUM EXTRACTGRANDALL DISTRIBUTING, LLC1de4e361-4e7b-4f7e-b6c8-30fa21e75bea2025-10-27WarningsExact identifier
application number: M031
LIENDREXPYRETHRUM EXTRACT, PIPERONYL BUTOXIDEMenper Distributors Inc.65f86a0d-0cf7-42f6-84de-4dc9e7791aba2025-07-22WarningsExact identifier
application number: M031
Lice No More Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTWeeks & Leo Co., Inc372819f1-0817-2cd5-e063-6294a90ac5bf2025-06-09WarningsExact identifier
application number: M031
Rite Aid Complete Lice Elimination KitPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTRite Aid0bf40aa5-b931-663e-e063-6394a90a803f2025-01-07WarningsExact identifier
application number: M031
Quita Piojos Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTDLC Laboratories82ce4cf7-ea46-c838-e053-2991aa0a9c382024-12-23WarningsExact identifier
application number: M031
ZAP Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTDLC laboratories Inc.82d24cd9-6615-7901-e053-2991aa0ad1682024-12-23WarningsExact identifier
application number: M031
CVS Health Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTCVS49da5655-28ab-09cf-e054-00144ff8d46c2024-12-19WarningsExact 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