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 15 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Gentle LaxativeBISACODYLCVS Pharmacy0cca1516-fc8d-4471-bd37-a6230fd225e22026-01-14WarningsExact identifier
application number: M007
Rite-Aid Gentle LaxativeBISACODYLRITE AID PHARMACY0fb853db-8d97-64d6-e063-6294a90abeb52026-01-14WarningsExact identifier
application number: M007
Rite-Aid Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fb8f488-3386-29b9-e063-6294a90a014c2026-01-14WarningsExact identifier
application number: M007
Rite-Aid Childrens Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fbe4dfd-1d5d-fc31-e063-6394a90ab3172026-01-14WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMTOP CARE (Topco Associates LLC)92659389-c36f-499b-b284-5b520e50e9a62026-01-14WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESAVPAKaf75d33f-b081-4b9d-bc12-d2829fa1f0cf2026-01-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)597d2e9c-1adb-4c7d-ada3-de5c2db69c742026-01-09WarningsExact identifier
application number: M007
Foster and Thrive Ready to Use Mineral oil LaxativeMINERAL OILStrategic Sourcing Services LLCea6da66c-6825-4cd7-8791-45b537bf203a2026-01-08WarningsExact identifier
application number: M007
Sunmark Saline Single LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMStrategic Sourcing Services LLC06720229-7d58-499e-b7de-cb4bda5ae4162026-01-08WarningsExact identifier
application number: M007
HealthMart Mineral Oil Single LaxativeMINERAL OILStrategic Sourcing Services LLC1238ec69-1ea3-4773-9f13-71f0ae0a35532026-01-08WarningsExact identifier
application number: M007
HealthMart Saline Single LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMStrategic Sourcing Services LLC689228de-1f3e-4205-853d-6004d62488572026-01-08WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacyc445864f-fc88-4885-9f40-d189b9dc42902026-01-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFIc46a1f7c-12e3-4be1-b9e4-d3edac0f43862026-01-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTOP CARE (Topco Associates LLC)44fe6ce0-5fed-418f-8a6a-d6132e2883282026-01-07WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMStrategic Sourcing Services LLC24e29f00-f1cf-4e92-bd67-3f6f820af7832026-01-07WarningsExact identifier
application number: M007
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMP & L Development, LLC33000a06-e030-433a-8f9c-7ae5c08037fa2026-01-06WarningsExact identifier
application number: M007
Stool Softener Regular StrengthDOCUSATE SODIUMSam's West, Inc1eca5910-b0bf-4e07-8211-36dba52b3de72026-01-06WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEMajor Pharmaceuticalsc3d14605-fdec-49fc-b0ee-d4c3ae5f42b52026-01-05WarningsExact identifier
application number: M007
GeriCare Sorbitol SolutionSORBITOLGERI-CARE PHARMACEUTICALS, CORPb4dd7a41-380e-d94b-e053-2a95a90ac34a2025-12-31WarningsExact identifier
application number: M007
Docusate Sodium LiquidDOCUSATE SODIUMLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c2025-12-31WarningsExact 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