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 · 874 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Epsom SaltMAGNESIUM SULFATECardinal Health, 110 dba Leaderd27dc1cc-5e17-40d3-84fe-c1792552cfd52026-08-25Warnings, Adverse reactionsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ccec364a-3135-4a5d-b4b0-86b832387b4e2026-08-24WarningsExact identifier
application number: M007
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.a1591da0-a1a9-9583-3cf5-788b8fee38142026-08-24Exact identifier
application number: M007
MiraFAST soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.2cee67dd-b71f-32b8-e063-6394a90ae8642026-08-21WarningsExact identifier
application number: M007
Senokot-SSTANDARDIZED SENNA CONCENTRATE AND DOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.c24cdc5e-62e0-41a6-8afb-512202a569f42026-08-21WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTAmerisourceBergen (Good Neighbor Pharmacy) 46122d22fb02f-09c4-476a-b6d6-d3a2fd30049d2026-08-18WarningsExact identifier
application number: M007
CVS Stool Softener Fruit PunchDOCUSATE SODIUMCVS PHARMACY, INC0e6900d6-7dc9-47d6-a006-1695feb8d5a52026-08-17WarningsExact identifier
application number: M007
CVS Senna LaxativeSENNOSIDESCVS PHARMACY5a5565b2-827f-4fcc-a835-d827f62da8f92026-08-17WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)306fd12b-ed60-40dc-a5be-2dc394bd29d22026-08-17WarningsExact identifier
application number: M007
CVS Health Childrens Saline LaxativeMAGNESIUM HYDROXIDECVS PHARMACY,INC.e57e5529-2190-4c66-8397-bc2848739e592026-08-14WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESMorepen Bio Inc562d1b9a-09d8-92fc-e063-6394a90a19932026-08-14WarningsExact identifier
application number: M007
CVS HealthNATURAL FIBER SUPPLEMENTCVS Pharmacy,Inc.04dbe9aa-ed18-4d76-a840-d010445a86432026-08-14WarningsExact identifier
application number: M007
CVS Fiber TherapyMETHYLCELLULOSECVS PHARMACYe066f5bd-5f34-4e04-beec-3c7d6db493812026-08-13WarningsExact identifier
application number: M007
Mineral oilMINERAL OILEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)92f2147d-b52d-4282-b217-28f6095dca0e2026-08-12WarningsExact identifier
application number: M007
CAREONE Orange FlavoredPSYLLIUM HUSKFOODHOLD USA4b1cccd2-e941-4d51-9924-4ca35e3a44292026-08-11WarningsExact identifier
application number: M007
CAREONEPSYLLIUM HUSKFOODHOLD USA3ec3ead0-382e-4765-bbe8-b21e7c7b42a62026-08-11WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f4671579-aed0-4f93-ab83-248e0d72b5b02026-08-10WarningsExact identifier
application number: M007
Docusate Sodium LiquidDOCUSATE SODIUM.50MG/5MLAldama Pharmaceuticals, Inc492b6d37-47cf-3a28-e063-6294a90a2a182026-08-10WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATESafeway Inc0b757160-f9eb-4413-9b43-97544c49c72f2026-08-10Warnings, Adverse reactionsExact identifier
application number: M007
SennosidesSENNOSIDESCardinal Health 107, LLC4a9e1cbe-ffe4-462f-a86d-078a357dcf492026-08-07WarningsExact 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