FDA.reportPublic FDA data

Fiber Lax

Product NDC
55289-949
11-digit product format
552890949
Labeler code
55289
Product ID
55289-949_419b8a9a-2ee8-ef30-e063-6294a90a3e94
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Polycarbophil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
730198a5-b6d9-4fc7-b053-a7c65a93c540Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-949-30Fiber Lax30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-949-30EA - Each55289-949711edde9-8542-46ff-a55e-a83260f0394c12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-949FIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 1 package rows20241012_730198a5-b6d9-4fc7-b053-a7c65a93c540.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 10 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral OilMINERAL OILBetter Living Brands, LLC7f2f1b30-497a-4c53-accc-8455169b17b32026-02-24Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEFamily Dollar Stores, Inccc97cfb5-cd40-4589-942a-5bee611a28122026-02-24Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEFamily Dollar Stores, Inc0ac1896d-7ed9-44e5-bf07-1478262372732026-02-24Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILChain Drug Marketing Association4a003bb1-425d-cd97-e063-6294a90a5dda2026-02-23Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEBetter Living Brands, LLCd8176ef6-cc68-4185-b5eb-e887562f6aaa2026-02-23Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEBetter Living Brands, LLC07732845-c9ce-47bb-8b63-36a3d5ddf8b72026-02-23Warnings, Adverse reactionsExact identifier
application number: M007
stimulant laxativeBISACODYLBIONPHARMA INC.4b1f7db3-c6a8-7f6a-e063-6394a90a58292026-02-22WarningsExact identifier
application number: M007
Castor OilCASTOR OILNice-Pak Products, LLCff6c8022-9522-4eae-b8ff-994ee37fba062026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILPerrigo Direct, Inc09e32476-1c60-4f1e-a51c-5fab2e744b302026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATEPerrigo Direct, Inc22991685-8228-41e1-a13e-f57961e8dd0e2026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATEPerrigo Direct, Inc24478279-9a11-4e12-956d-57dc7debf9412026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILPerrigo Direct, Incf1656280-fad9-4922-9d5c-be774a8b14222026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEMeijer, Inc.3b8eae67-9e27-46bd-ab2b-02c719786bab2026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILMeijer, Inc.c4d03837-193b-4817-8b78-fbdfb9122f192026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEMeijer, Inc.2070a4a6-7968-49f2-84ec-53bd1cd824452026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILMeijer, Inc.652d1da9-a71f-4113-9ef3-da09167246252026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
SENNA-SDOCUSATE SODIUM AND SENNOSIDESAdvanced Rx LLCd148be81-79b4-41f7-b8d8-a0e85b6615922026-02-18WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATETarget Corporationa8e52a22-7c30-40c0-8f78-523775743bfb2026-02-18Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILTarget Corporation526508f0-e908-4e3d-88f5-404a95f6de762026-02-18Warnings, Adverse reactionsExact identifier
application number: M007
CVS PharmacySALINE LAXATIVECVS Pharmacyedd58c52-18de-4ec4-aec3-44f3e17607a72026-02-17WarningsExact 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-949-305528909493030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-949-30) 2021-03-270000-00-00NoNoCurrent