FDA.reportPublic FDA data

Fiber Caps

Product NDC
53041-147
11-digit product format
530410147
Labeler code
53041
Product ID
53041-147_253b0ee2-8659-43db-9c46-eb4ef3915a19
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium polycarbophil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Guardian Drug Company
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-07-15
Substance
CALCIUM POLYCARBOPHIL
Active strength
625 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fiber Caps
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
31e6b0c7-1d4a-4660-ae87-9d18e0001dcdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-147-27Fiber Caps90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM POLYCARBOPHILACTIVE INGREDIENT8F049NKY49FIBER CAPS (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [GUARDIAN DRUG COMPANY]1
POLYCARBOPHILACTIVE MOIETYW25LM17A4WFIBER CAPS (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [GUARDIAN DRUG COMPANY]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKFIBER CAPS (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [GUARDIAN DRUG COMPANY]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RFIBER CAPS (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [GUARDIAN DRUG COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFIBER CAPS (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [GUARDIAN DRUG COMPANY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFIBER CAPS (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [GUARDIAN DRUG COMPANY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFIBER CAPS (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [GUARDIAN DRUG COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FIBER CAPS (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [GUARDIAN DRUG COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFIBER CAPS (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [GUARDIAN DRUG COMPANY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FIBER CAPS (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [GUARDIAN DRUG COMPANY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFIBER CAPS (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [GUARDIAN DRUG COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-147FIBER CAPS (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [GUARDIAN DRUG COMPANY]5Current NDC, Legacy NDC, 1 package rows20241222_31e6b0c7-1d4a-4660-ae87-9d18e0001dcd.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 1 of 44 · 868 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
application number: M007
Curewell Senna SyrupSENNOSIDESRMT HEALTH LLC57345324-5140-5cde-e063-6294a90ab97c2026-07-22WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATE ORAL SOLUTIONWALGREEN COMPANY4ffe54ae-3126-ba58-e063-6294a90a88772026-07-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackdeca083b-5c72-40fa-9021-b74028426a5a2026-07-20WarningsExact identifier
application number: M007
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-07-20WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCfc5e82b6-e25c-4686-9781-2205819685f52026-07-20WarningsExact identifier
application number: M007
Best Choice Fiber Therapy Orange FlavorPSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)0b25f6c0-441b-41ef-ab19-2a29705a56c62026-07-17WarningsExact identifier
application number: M007
Best Choice Fiber Therapy original coarsePSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)d7eb71af-17e3-465e-b464-f77b3be7266d2026-07-17WarningsExact identifier
application number: M007
Best ChoiceCALCIUM POLYCARBOPHILBEST CHOICE (VALU MERCHANDISERS COMPANY)24eb538f-abcb-4a91-b691-a8aac01c952a2026-07-17WarningsExact identifier
application number: M007
Best Choice Fiber LaxativePSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)92b46689-b5fc-41f4-91ac-535699900b392026-07-17WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATECVS Pharmacy, Inc.498acb19-b2f4-4af0-8996-390115c17fe02026-07-17Warnings, Adverse reactionsExact identifier
application number: M007
Best Choice Fiber TherapyMETHYLCELLULOSEBEST CHOICE (VALU MERCHANDISERS COMPANY)fab6567f-d988-43f2-a6cf-44e5b24af2792026-07-17WarningsExact identifier
application number: M007
stool softenerDOCUSATE SODIUMAmazon.com Services LLC4f83953e-3779-43b7-a5c6-7442a0675d9b2026-07-16WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)183576bd-c252-471b-8797-32cac5b0329c2026-07-16WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMWalgreens3f9d54d9-a9d5-40ff-a8a2-431997b589992026-07-16WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWalgreens7174021b-bdc0-4fd3-90e7-3904980033c42026-07-16WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLCff2179bd-cc76-9ee9-e053-6294a90a01c92026-07-15WarningsExact identifier
application number: M007
FEVIA Constipation ControlDOCUSATE SODIUMVIVUNT PHARMA LLC4b21ca11-b81f-402c-e063-6394a90a3acb2026-07-15WarningsExact identifier
application number: M007
Docusate Sodium softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-07-14WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLC56957a51-7366-f7ed-e063-6294a90abfc52026-07-14WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN31e6b0c7-1d4a-4660-ae87-9d18e0001dcd5
308934calcium polycarbophil 625 MG Oral TabletSCD31e6b0c7-1d4a-4660-ae87-9d18e0001dcd5
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY31e6b0c7-1d4a-4660-ae87-9d18e0001dcd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53041-147-275304101472790 TABLET, FILM COATED in 1 BOTTLE (53041-147-27) 2010-07-150000-00-00NoNoCurrent