FDA.reportPublic FDA data

Fibercon

Product NDC
80070-500
11-digit product format
800700500
Labeler code
80070
Product ID
80070-500_4cd75c27-5ebb-ba3c-e063-6394a90a1e84
Type
HUMAN OTC DRUG
Nonproprietary name
CALCIUM POLYCARBOPHIL
Dosage form
TABLET
Route
ORAL
Labeler
Foundation Consumer Brands
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-04
Substance
CALCIUM POLYCARBOPHIL
Active strength
625 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
Fibercon
Listing expiration
2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
210665Internal RxNorm lookup
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
7992a4bb-5535-4a1d-867d-a99f7e0c1be7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80070-500-14Fibercon140 in 1 BOTTLETABLET1404
80070-500-28Fibercon280 in 1 BOTTLETABLET2804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80070-500FIBERCON (CALCIUM POLYCARBOPHIL) TABLET [FOUNDATION CONSUMER BRANDS]2Current NDC, Legacy NDC, 2 package rows20240807_7992a4bb-5535-4a1d-867d-a99f7e0c1be7.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 33 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stratuscare Glycerin Laxative PediatricGLYCERINStratus Pharmaceuticals6ae6d3c4-bb3b-4436-b76d-8654bf871e662024-11-01WarningsExact identifier
application number: M007
Rite Aid Fiber TherapyMETHYLCELLULOSERITE AID CORPORATIONe50cea80-c020-4b85-b61f-d053f11f479b2024-10-30WarningsExact identifier
application number: M007
Rite Aid Fiber CapletsCALCIUM POLYCARBOPHILRITE AID CORPORATION06e46cb0-2928-479e-984d-2305fff995e02024-10-30WarningsExact identifier
application number: M007
Premier Value Orange FlavorPSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC2d580965-2bef-46ee-8532-fbe34330a4b42024-10-28WarningsExact identifier
application number: M007
Premier Value Fiber TherapyMETHYLCELLULOSEPHARMACY VALUE ALLIANCE, LLCb875d5f8-02f3-4474-9fda-83091bc7de042024-10-28WarningsExact identifier
application number: M007
Premier Value Fiber Therapy Original CoarsePSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC8c85a13d-ae99-4599-9a28-c3965caa63762024-10-28WarningsExact identifier
application number: M007
Premier ValueCALCIUM POLYCARBOPHILPHARMACY VALUE ALLIANCE, LLC4d766548-00d0-41bd-bb58-b69e037c77e22024-10-28WarningsExact identifier
application number: M007
Premier Value FiberPSYLLIUM HUSKChain Drug Consortium, LLCc507fe4a-1f8e-4780-a2f5-9da6e5922bef2024-10-28WarningsExact identifier
application number: M007
Premier Value Fiber Therapy Orange FlavorPSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC85651bd7-e959-4455-a5ed-bd0223ce05632024-10-28WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESBETTER LIVING BRANDS LLC.f2c61c71-9a23-4bd3-e053-2a95a90ad4602024-10-26WarningsExact identifier
application number: M007
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.ae367381-7146-4307-823d-2bb44c1d42002024-10-25WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETarget Corporationf7309f4a-f1f5-420e-bfc7-fb4495a5afba2024-10-24WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETarget Corporation2540ae39-2218-0f6a-e063-6294a90a5efc2024-10-24WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMSam's West Incb0e99ebb-41fc-459f-86d2-f0e3527f97b02024-10-24WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMA-S Medication Solutionsef05ad45-7082-43e6-9533-a79c5aa0f3732024-10-22WarningsExact identifier
application number: M007
Bliss GVS ChildrenGLYCERINBliss GVS Pharma Limited03237ed2-265f-4acd-b504-d82b9263287c2024-10-17WarningsExact identifier
application number: M007
NATURAL Epsom SaltMAGNESIUM SULFATEUniversal Distribution Center LLCb2682e51-ffa4-4556-b2a6-b0dbd543fd4f2024-10-16WarningsExact identifier
application number: M007
Bliss GVSGLYCERINBliss GVS Pharma Limited1a3982a1-9ce9-4a1a-ba73-ebe2d86471092024-10-10WarningsExact identifier
application number: M007
BisacodylBISACODYLPadagis US LLC7eada0fc-5f83-43da-a56f-b0f5372982082024-10-10WarningsExact identifier
application number: M007
exchange select stool softenerDOCUSATE SODIUMArmy & Air Force Exchange Service14985848-d791-42b9-ad7e-810a85bb1ee12024-10-07WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN7992a4bb-5535-4a1d-867d-a99f7e0c1be74
210665FiberCon 625 MG Oral TabletPSN7992a4bb-5535-4a1d-867d-a99f7e0c1be74
210665calcium polycarbophil 625 MG Oral Tablet [FiberCon]SBD7992a4bb-5535-4a1d-867d-a99f7e0c1be74
308934calcium polycarbophil 625 MG Oral TabletSCD7992a4bb-5535-4a1d-867d-a99f7e0c1be74
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY7992a4bb-5535-4a1d-867d-a99f7e0c1be74
210665FiberCon (calcium polycarbophil 625 MG) Oral TabletSY7992a4bb-5535-4a1d-867d-a99f7e0c1be74
210665FiberCon 625 MG Oral TabletSY7992a4bb-5535-4a1d-867d-a99f7e0c1be74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80070-500-1480070050014140 TABLET in 1 BOTTLE (80070-500-14) 140 tablet2021-04-040000-00-00NoNoCurrent
80070-500-2880070050028280 TABLET in 1 BOTTLE (80070-500-28) 280 tablet2025-11-01NoNoCurrent
80070-500-90800700500901 BOTTLE in 1 CARTON (80070-500-90) > 90 TABLET in 1 BOTTLE1 bottle2021-04-150000-00-00NoNoCurrent