FDA.reportPublic FDA data

MebendamaX

Product NDC
55758-441
11-digit product format
557580441
Labeler code
55758
Product ID
55758-441_37db6b69-9455-c41c-e063-6294a90ae3ee
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrantel Pamoate
Dosage form
TABLET
Route
ORAL
Labeler
Pharmadel LLC
Application
M024
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-01
Substance
PYRANTEL PAMOATE
Active strength
180 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MebendamaX
Brand name suffix
Pinworm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRANTEL PAMOATE180 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81BK194Z5MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199107Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d75b912-3550-7d4c-e063-6294a90ad5faAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-441-10MebendamaXPinworm10 in 1 CARTONTABLET102
55758-441-10MebendamaXPinworm1 in 1 BLISTER PACKTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-441MEBENDAMAX PINWORM (PYRANTEL PAMOATE) TABLET [PHARMADEL LLC]1Current NDC, 2 package rows20240802_1d75b912-3550-7d4c-e063-6294a90ad5fa.zip

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 · 18 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
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
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
ndc (product): 55758-441
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199107pyrantel pamoate 180 MG Oral TabletPSN1d75b912-3550-7d4c-e063-6294a90ad5fa2
199107pyrantel 180 MG Oral TabletSCD1d75b912-3550-7d4c-e063-6294a90ad5fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55758-441-105575804411010 BLISTER PACK in 1 CARTON (55758-441-10) / 1 TABLET in 1 BLISTER PACK10 blister pack2024-08-01NoNoCurrent