FDA.reportPublic FDA data

SYNTHABIO Ivermectin

Product NDC
87782-001
11-digit product format
877820001
Labeler code
87782
Product ID
87782-001_54d87fee-e6f4-74a9-e063-6394a90ae7ec
Type
HUMAN OTC DRUG
Nonproprietary name
Ivermectin
Dosage form
LOTION
Route
TOPICAL
Labeler
Shenzhen Xuyan Technology Co., Ltd.
Application
M024
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-12
Substance
IVERMECTIN
Active strength
.5 g/100g
Pharmacologic classes
Antiparasitic [EPC]; Pediculicide [EPC]
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SYNTHABIO IvermectinIVERMECTINShenzhen Xuyan Technology Co., Ltd.540d6a24-68bf-50c8-e063-6294a90aaa302026-06-22WarningsExact identifier
application number: M024
ndc (product): 87782-001
PINRIDPYRANTEL PAMOATEYYBA CORP59da86a4-db0d-4551-9128-e09a4e85cd782026-05-25WarningsExact identifier
application number: M024
PINRIDPYRANTEL PAMOATEYYBA CORP52a9b5c8-08e6-b91e-e063-6294a90a0e0d2026-05-25WarningsExact identifier
application number: M024
PREPAKU FENBENDAZOLE Canine DewormerFENBENDAZOLEShenzhen Zhenshangzekai Technology Co., Ltd.4d722051-6a49-75ea-e063-6294a90a7b4e2026-03-20WarningsExact identifier
application number: M024
IvermectinIVERMECTINShenzhen Zhenshangzekai Technology Co, Ltd.4629a0e0-5cc4-3d72-e063-6294a90ae00d2026-03-20WarningsExact identifier
application number: M024
pinworm treatmentPYRANTEL PAMOATEBIONPHARMA INC.3cf96d04-e8bc-31af-e063-6294a90a0db82026-01-23WarningsExact identifier
application number: M024
pinworm treatmentPYRANTEL PAMOATEAMERISOURCE BERGEN4837905f-1037-a319-e063-6294a90aba042026-01-21WarningsExact identifier
application number: M024
Pyrantel PamoatePYRANTEL PAMOATEJefferson Labse862b337-2991-4b56-8584-fd80dccd725f2025-12-19WarningsExact identifier
application number: M024
pinworm treatmentPYRANTEL PAMOATESTRATEGIC SOURCING SERVICES453c0645-f2b4-aa4a-e063-6294a90af1fb2025-12-05WarningsExact identifier
application number: M024
LombrixPYRANTEL PAMOATEOPMX LLC3f940481-8e75-0bc7-e063-6394a90af1cd2025-09-24WarningsExact identifier
application number: M024
PARASITOLPYRANTEL PAMOATEMenper Distributors Inc.cd5eb4c9-d0f0-4be7-84eb-88ebc4632dc62025-07-22WarningsExact identifier
application number: M024
BismutinaBISMUTH SUBSALICYLATEMenper Distributors, Inc.14bbbdbb-87c8-47a9-9147-7e0f1b75c7b92025-07-22WarningsExact identifier
application number: M024
PINRIDPYRANTEL PAMOATEYYBA CORPfc225b5b-0ce8-4394-a643-39dbc674d7cd2025-07-02WarningsExact identifier
application number: M024
MebendamaX PinwormPYRANTEL PAMOATEPharmadel LLC1d75b912-3550-7d4c-e063-6294a90ad5fa2025-06-18WarningsExact identifier
application number: M024
Pyrantel PamoatePYRANTEL PAMOATEProMex LLCe68c503a-6f79-4f83-a6f3-c12a13fb06a02024-12-18WarningsExact identifier
application number: M024
Pinworm MedicinePYRANTEL PAMOATEREESE PHARMACEUTICAL CO.f23d5092-48ca-46c4-830a-c34d0a3a7f572024-12-18WarningsExact identifier
application number: M024
Walgreens Pinworm MedicinePYRANTEL PAMOATEWalgreens7fd58448-6846-4d8e-994c-d0ca2fd38e682024-12-18WarningsExact identifier
application number: M024
CVS Pinworm TreatmentPYRANTEL PAMOATECVS PHARMACY INCd079008a-c87a-45f2-8775-0e40241761f02024-12-18WarningsExact identifier
application number: M024
VRMX 500PYRANTEL PAMOATEOPMX LLCe119cad8-9814-7d5a-e053-2995a90afde52024-02-06WarningsExact identifier
application number: M024

Additional Listing Data#

Finished product
Yes
Brand name base
SYNTHABIO Ivermectin
Listing expiration
2027-12-31

Active Ingredients#

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

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
540d6a24-68bf-50c8-e063-6294a90aaa30Available on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
87782-001-02877820001021 TUBE in 1 BOX (87782-001-02) / 117 g in 1 TUBE (87782-001-01)1 tube2026-06-120Current