FDA.reportPublic FDA data

FIBER TABS

Product NDC
0904-2500
11-digit product format
009042500
Labeler code
0904
Product ID
0904-2500_44fe77d2-515f-0753-e063-6394a90a62f2
Type
HUMAN OTC DRUG
Nonproprietary name
calcium polycarbophil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-09-01
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
FIBER TABS
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
284308Internal 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
bee100da-b9c9-4261-b6e6-7b3db5715625Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-2500-91FIBER TABS90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-2500-91EA - Each0904-25007a5bbbbb-bd50-41f4-a837-42d180545d8b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM POLYCARBOPHILACTIVE INGREDIENT8F049NKY49FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]2
POLYCARBOPHILACTIVE MOIETYW25LM17A4WFIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]2
12-HYDROXYSTEARIC ACIDINACTIVE INGREDIENT933ANU3H2SFIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]2
CARAMELINACTIVE INGREDIENTT9D99G2B1RFIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPFIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]2
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFIBER TABS (CALCIUM POLYCARBOPHIL) TABLET [MAJOR PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-2500FIBER TABS (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]8Current NDC, Legacy NDC, 1 package rows20231212_bee100da-b9c9-4261-b6e6-7b3db5715625.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 TabletPSNbee100da-b9c9-4261-b6e6-7b3db57156259
284308Fiber Tab 625 MG Oral TabletPSNbee100da-b9c9-4261-b6e6-7b3db57156259
284308calcium polycarbophil 625 MG Oral Tablet [Fiber Tab]SBDbee100da-b9c9-4261-b6e6-7b3db57156259
308934calcium polycarbophil 625 MG Oral TabletSCDbee100da-b9c9-4261-b6e6-7b3db57156259
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSYbee100da-b9c9-4261-b6e6-7b3db57156259
284308Fiber Tab 625 MG Oral TabletSYbee100da-b9c9-4261-b6e6-7b3db57156259

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-2500-910090425009190 TABLET, FILM COATED in 1 BOTTLE (0904-2500-91) 2010-09-010000-00-00NoNoCurrent