FDA.reportPublic FDA data

SYNTHABIO Ivermectin

Product NDC
87782-001
Requested package NDC
87782-001-02
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

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

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 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 (package): 87782-001-02
ndc (product): 87782-001
ndc11 (package): 87782000102
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

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