FDA.reportPublic FDA data

Fiber Lax

Product NDC
0536-4306
11-digit product format
005364306
Labeler code
0536
Product ID
0536-4306_44fe10f1-66d5-9187-e063-6294a90a4d7f
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Polycarbophil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rugby Laboratories
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 Lax
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
318d81ed-0b06-4d21-8b97-2d1f0267c781Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-4306-05Fiber Lax500 in 1 BOTTLETABLET, FILM COATED5008
0536-4306-08Fiber Lax2 in 1 CARTONTABLET, FILM COATED28
0536-4306-08Fiber Lax30 in 1 BLISTER PACKTABLET, FILM COATED308
0536-4306-11Fiber Lax90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-4306-05EA - Each0536-4306463c1279-6853-4f79-912a-8572fd9cc5cb12012-07-24
0536-4306-08EA - Each0536-43060195b521-a1e1-41ec-8d0b-23b27de41bb112012-07-24
0536-4306-11EA - Each0536-43068919242e-6c8d-4c4a-83bc-af8ed23ccb9612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM POLYCARBOPHILACTIVE INGREDIENT8F049NKY49FIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
POLYCARBOPHILACTIVE MOIETYW25LM17A4WFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CARAMELINACTIVE INGREDIENTT9D99G2B1RFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9FIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CALCIUM POLYCARBOPHILACTIVE INGREDIENT8F049NKY49FIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
POLYCARBOPHILACTIVE MOIETYW25LM17A4WFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
CARAMELINACTIVE INGREDIENTT9D99G2B1RFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9FIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]13
CALCIUM POLYCARBOPHILACTIVE INGREDIENT8F049NKY49FIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [RUGBY LABORATORIES]2
POLYCARBOPHILACTIVE MOIETYW25LM17A4WFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [RUGBY LABORATORIES]2
CARAMELINACTIVE INGREDIENTT9D99G2B1RFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [RUGBY LABORATORIES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [RUGBY LABORATORIES]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [RUGBY LABORATORIES]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [RUGBY LABORATORIES]2
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9FIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [RUGBY LABORATORIES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [RUGBY LABORATORIES]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [RUGBY LABORATORIES]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [RUGBY LABORATORIES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [RUGBY LABORATORIES]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [RUGBY LABORATORIES]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [RUGBY LABORATORIES]2
CALCIUM POLYCARBOPHILACTIVE INGREDIENT8F049NKY49FIBER LAX TABLET [CONTRACT PHARMACY SERVICES-PA]1
CALCIUMACTIVE MOIETYSY7Q814VUPFIBER LAX TABLET [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-4306FIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [RUGBY LABORATORIES]7Current NDC, Legacy NDC, 4 package rows20231212_318d81ed-0b06-4d21-8b97-2d1f0267c781.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 17 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DDM Castor OilCASTOR OILDiscount Drug Mart5d1583fa-968a-5987-e053-2991aa0a0d602025-12-19WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcb0765cb-f48e-4daa-97b8-2897a2d955872025-12-19WarningsExact identifier
application number: M007
Humco Castor OilCASTOR OILHumco holding Group, Inc.f2676cf2-f6fb-46b8-b723-5497f16559022025-12-18WarningsExact identifier
application number: M007
Humco Castor Oil (Regular)CASTOR OILHumco Holding Group, Inc.ccf25c1f-d8a2-49b9-8e09-88e6616c9ade2025-12-18WarningsExact identifier
application number: M007
Meijer Magnesium Hydroxide Laxative Soft ChewMAGNESIUM HYDROXIDEMeijer23f826c3-1ad5-b3c8-e063-6394a90a655e2025-12-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMStrategic Sourcing Services LLCba51cca1-b70b-476e-80e6-20cd52292e652025-12-17WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMCVS Pharmacya694b4f3-6112-4a1d-a06e-9e5b20fd3d7b2025-12-17WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCARDINAL HEALTH 110, LLC. DBA LEADER 70000da5ccd75-8a2f-4f90-ae8a-97d81b8579d22025-12-17WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMorepen Laboratories Limited3643eabf-e339-f02c-e063-6394a90aa6a82025-12-16WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEMeijer Distribution Incf425a7aa-2503-2fe8-e053-2995a90ab3522025-12-16WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEMeijer Distribution Inc.f42591f9-c842-018f-e053-2995a90a480f2025-12-16WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEMAJOR Pharmaceuticals Inc.673311f7-0b83-410c-a480-8e57d01902962025-12-11WarningsExact identifier
application number: M007
GeriCare Docusate Sodium LiquidDOCUSATE SODIUMGERI-CARE PHARMACEUTICALS, CORPd599ff49-c9a4-401a-a50b-63d89749bbed2025-12-11WarningsExact identifier
application number: M007
GeriCare Senna SyrupSENNOSIDESGeri-Care Pharmaceutical Corp.05a54614-a6ad-4861-87b8-9e2ee49bad202025-12-11WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMMajor Pharmaceuticals3e8321cf-7eda-d70c-e063-6394a90a35a52025-12-10WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMHEB2f103a88-4cab-d4b9-e063-6394a90ac7fc2025-12-09WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMHEB2efb4c5a-2c5e-acf6-e063-6394a90a934e2025-12-08WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMHEB2f10041a-8c88-09a5-e063-6294a90a07cc2025-12-08WarningsExact identifier
application number: M007
QUALITY CHOICE Fiber TherapyMETHYLCELLULOSECHAIN DRUG MARKETING ASSOCIATION77ac079c-d957-4706-8241-570d7fcfe3aa2025-12-04WarningsExact identifier
application number: M007
Phillips Stool Softener Bulk DocusateDOCUSATE SODIUMBayer HealthCare LLC.b0462555-5554-4a17-a1fe-4206a4fd350d2025-12-04WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308934calcium polycarbophil 625 MG Oral TabletPSN730198a5-b6d9-4fc7-b053-a7c65a93c54010
308934calcium polycarbophil 625 MG Oral TabletSCD730198a5-b6d9-4fc7-b053-a7c65a93c54010
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY730198a5-b6d9-4fc7-b053-a7c65a93c54010
308934calcium polycarbophil 625 MG Oral TabletPSN318d81ed-0b06-4d21-8b97-2d1f0267c7818
308934calcium polycarbophil 625 MG Oral TabletSCD318d81ed-0b06-4d21-8b97-2d1f0267c7818
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSY318d81ed-0b06-4d21-8b97-2d1f0267c7818
308934calcium polycarbophil 625 MG Oral TabletPSNe1e31142-4256-4b12-8d2b-29a6cf45dc911
308934calcium polycarbophil 625 MG Oral TabletSCDe1e31142-4256-4b12-8d2b-29a6cf45dc911
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSYe1e31142-4256-4b12-8d2b-29a6cf45dc911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-4306-0500536430605500 TABLET, FILM COATED in 1 BOTTLE (0536-4306-05) 2010-09-010000-00-00NoNoCurrent
0536-4306-08005364306082 BLISTER PACK in 1 CARTON (0536-4306-08) / 30 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2010-09-010000-00-00NoNoCurrent
0536-4306-110053643061190 TABLET, FILM COATED in 1 BOTTLE (0536-4306-11) 2010-09-010000-00-00NoNoCurrent