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 Identifiers#

Field, Values table
FieldValues
Unii81BK194Z5M
Rxcui199106

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

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