FDA.reportPublic FDA data

pinworm treatment

Product NDC
69452-515
11-digit product format
694520515
Labeler code
69452
Product ID
69452-515_48ebc5ed-d3de-80c1-e063-6294a90ac01a
Type
HUMAN OTC DRUG
Nonproprietary name
pyrantel pamoate
Dosage form
SUSPENSION
Route
ORAL
Labeler
BIONPHARMA INC.
Application
M024
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-08
Substance
PYRANTEL PAMOATE
Active strength
144 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
pinworm treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRANTEL PAMOATE144 mg/mL

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
199106Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3cf96d04-e8bc-31af-e063-6294a90a0db8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-515-36pinworm treatment30 mL in 1 BOTTLESUSPENSION302
69452-515-38pinworm treatment2 in 1 CARTONSUSPENSION22
69452-515-49pinworm treatment1 in 1 CARTONSUSPENSION12
69452-515-49pinworm treatment30 mL in 1 BOTTLESUSPENSION302
69452-515-88pinworm treatment473 mL in 1 BOTTLESUSPENSION4732

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
ndc (product): 69452-515
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199106pyrantel pamoate 144 MG in 1 mL Oral SuspensionPSN3cf96d04-e8bc-31af-e063-6294a90a0db82
199106pyrantel pamoate 144 MG/ML Oral SuspensionSCD3cf96d04-e8bc-31af-e063-6294a90a0db82
199106pyrantel pamoate 144 MG per 1 ML Oral SuspensionSY3cf96d04-e8bc-31af-e063-6294a90a0db82
199106pyrantel pamoate 144 MG/ML (pyrantel base 50 MG/ML) Oral SuspensionSY3cf96d04-e8bc-31af-e063-6294a90a0db82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69452-515-366945205153630 mL in 1 BOTTLE30 mlHistorical
69452-515-38694520515382 BOTTLE in 1 CARTON (69452-515-38) / 30 mL in 1 BOTTLE (69452-515-36) 2 bottle2025-09-08NoNoCurrent
69452-515-49694520515491 BOTTLE in 1 CARTON (69452-515-49) / 30 mL in 1 BOTTLE1 bottle2026-01-23NoNoCurrent
69452-515-8869452051588473 mL in 1 BOTTLE (69452-515-88) 473 ml2025-09-08NoNoCurrent