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 19 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMThe Kroger Co.9019ae9e-da3e-4ed1-b83e-d9a6375e9c302025-11-25WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMFamily Dollar (FAMILY WELLNESS)d61ba4ef-5b03-4d29-b1fd-81591f0c8a2c2025-11-25WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM AND SENNOSIDESMarlex Pharmaceuticals Inc9c87759f-3856-4f30-b5ea-4b37ed90f18c2025-11-21WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMarlex Pharmaceuticals Inc5ca287a3-c4f6-402d-978e-cd1328bdbc472025-11-21WarningsExact identifier
application number: M007
SAMS WESTPSYLLIUM HUSKSAM'S WEST INC2aaf5d99-6d28-4fa6-b3c5-52dcfc94dac02025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corpbb47ad1f-251c-491e-8ddd-6f6f719efa152025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEChain Drug Marketing Association440a96bb-9e68-bdcc-e063-6294a90a67932025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEChain Drug Marketing Association4277b174-4ce5-4950-8e9b-75e3c019a8f32025-11-20WarningsExact identifier
application number: M007
FleetSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.c1677d70-203b-493e-88f0-815a66133f1d2025-11-20WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEFAMILY DOLLAR SERVICES INC5ea9237a-7895-388d-e053-2991aa0a92b02025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEFAMILY DOLLAR SERVICES INC5ea9305b-2997-49d3-e053-2991aa0a1fa12025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDECVS3c8f5b69-56f2-4e9d-e054-00144ff88e882025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDECVS3cdf1975-2607-14f5-e054-00144ff8d46c2025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDERITE AID PHARMACY60284706-445f-f795-e053-2a91aa0a0a122025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corp9f588e9b-56c5-4426-89fc-7b83e2d0ad1a2025-11-19WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEFact Productsaebbdd10-0650-6efe-e053-2a95a90a0ab22025-11-19WarningsExact identifier
application number: M007
Stool Softener with Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESP & L Development, LLC0cbe3b61-ce35-4be1-9caf-9c61fce10ca22025-11-17WarningsExact identifier
application number: M007
good sense stool softenerDOCUSATE SODIUML. Perrigo Company4658d162-6e62-4d84-b5d6-7bf16c9155582025-11-14WarningsExact identifier
application number: M007
Topco Fiber Therapy Sugar FreePSYLLIUM HUSKTOPCO ASSOCIATES LLC2c61e73e-b3f7-4ab2-8bda-e65a2c0b35602025-11-10WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILLEADER/ Cardinal Health 110, Inc.b4637e18-c65f-0e81-e053-2a95a90a22842025-11-06WarningsExact 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