FDA.reportPublic FDA data

Calcium Polycarbophil

Product NDC
70369-006
11-digit product format
703690006
Labeler code
70369
Product ID
70369-006_31db774c-a120-fb83-e063-6394a90a51ca
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Polycarbophil
Dosage form
TABLET
Route
ORAL
Labeler
CITRAGEN PHARMACEUTICALS, INC.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-01
Substance
CALCIUM POLYCARBOPHIL
Active strength
625 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Calcium Polycarbophil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM POLYCARBOPHIL625 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8F049NKY49Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308934Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b23dd90f-ba5a-80fc-e053-2995a90a2286Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70369-006-08Calcium Polycarbophil120 in 1 BOTTLETABLET1203
70369-006-10Calcium Polycarbophil240 in 1 BOTTLETABLET2403

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 17 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DDM Castor OilCASTOR OILDiscount Drug Mart5d1583fa-968a-5987-e053-2991aa0a0d602025-12-19WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcb0765cb-f48e-4daa-97b8-2897a2d955872025-12-19WarningsExact identifier
application number: M007
Humco Castor OilCASTOR OILHumco holding Group, Inc.f2676cf2-f6fb-46b8-b723-5497f16559022025-12-18WarningsExact identifier
application number: M007
Humco Castor Oil (Regular)CASTOR OILHumco Holding Group, Inc.ccf25c1f-d8a2-49b9-8e09-88e6616c9ade2025-12-18WarningsExact identifier
application number: M007
Meijer Magnesium Hydroxide Laxative Soft ChewMAGNESIUM HYDROXIDEMeijer23f826c3-1ad5-b3c8-e063-6394a90a655e2025-12-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMStrategic Sourcing Services LLCba51cca1-b70b-476e-80e6-20cd52292e652025-12-17WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMCVS Pharmacya694b4f3-6112-4a1d-a06e-9e5b20fd3d7b2025-12-17WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCARDINAL HEALTH 110, LLC. DBA LEADER 70000da5ccd75-8a2f-4f90-ae8a-97d81b8579d22025-12-17WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMorepen Laboratories Limited3643eabf-e339-f02c-e063-6394a90aa6a82025-12-16WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEMeijer Distribution Incf425a7aa-2503-2fe8-e053-2995a90ab3522025-12-16WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEMeijer Distribution Inc.f42591f9-c842-018f-e053-2995a90a480f2025-12-16WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEMAJOR Pharmaceuticals Inc.673311f7-0b83-410c-a480-8e57d01902962025-12-11WarningsExact identifier
application number: M007
GeriCare Docusate Sodium LiquidDOCUSATE SODIUMGERI-CARE PHARMACEUTICALS, CORPd599ff49-c9a4-401a-a50b-63d89749bbed2025-12-11WarningsExact identifier
application number: M007
GeriCare Senna SyrupSENNOSIDESGeri-Care Pharmaceutical Corp.05a54614-a6ad-4861-87b8-9e2ee49bad202025-12-11WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMMajor Pharmaceuticals3e8321cf-7eda-d70c-e063-6394a90a35a52025-12-10WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMHEB2f103a88-4cab-d4b9-e063-6394a90ac7fc2025-12-09WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMHEB2efb4c5a-2c5e-acf6-e063-6394a90a934e2025-12-08WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMHEB2f10041a-8c88-09a5-e063-6294a90a07cc2025-12-08WarningsExact identifier
application number: M007
QUALITY CHOICE Fiber TherapyMETHYLCELLULOSECHAIN DRUG MARKETING ASSOCIATION77ac079c-d957-4706-8241-570d7fcfe3aa2025-12-04WarningsExact identifier
application number: M007
Phillips Stool Softener Bulk DocusateDOCUSATE SODIUMBayer HealthCare LLC.b0462555-5554-4a17-a1fe-4206a4fd350d2025-12-04WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308934calcium polycarbophil 625 MG Oral TabletPSNb23dd90f-ba5a-80fc-e053-2995a90a22863
308934calcium polycarbophil 625 MG Oral TabletSCDb23dd90f-ba5a-80fc-e053-2995a90a22863
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSYb23dd90f-ba5a-80fc-e053-2995a90a22863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70369-006-0870369000608120 TABLET in 1 BOTTLE (70369-006-08) 120 tablet2025-07-01NoNoCurrent
70369-006-1070369000610240 TABLET in 1 BOTTLE (70369-006-10) 240 tablet2025-07-01NoNoCurrent