FDA.reportPublic FDA data

FIBER LAXATIVE CAPLETS

Product NDC
77333-120
11-digit product format
773330120
Labeler code
77333
Product ID
77333-120_5d28c171-a408-24d4-e063-6294a90abe0c
Type
HUMAN OTC DRUG
Nonproprietary name
CALCIUM POLYCARBOPHIL
Dosage form
TABLET
Route
ORAL
Labeler
Gendose Pharmaceuticals, LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-02
Substance
CALCIUM POLYCARBOPHIL
Active strength
625 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct77333-120IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77333-12077333-120-50IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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 LAXATIVE CAPLETS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM POLYCARBOPHIL625 mg/1

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-05-02GENDOSE - FIBER LAXATIVE CAPLETS (77333-120)
2024-05-02GENDOSE - FIBER LAXATIVE CAPLETS (77333-120)
2024-01-30GENDOSE - FIBER LAXATIVE CAPLETS (77333-120)
2024-01-30GENDOSE - FIBER LAXATIVE CAPLETS (77333-120)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77333-120-25FIBER LAXATIVE CAPLETS1 in 1 BLISTER PACKTABLET16
77333-120-50FIBER LAXATIVE CAPLETS50 in 1 BOXTABLET506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-120-25EA - Each77333-12000d2b681-b51d-4f79-8e75-ad6a2a4d7f2812022-10-06
77333-120-50EA - Each77333-120f371e8ef-063a-4465-aa81-4f518adc663f12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77333-120FIBER LAXATIVE CAPLETS (CALCIUM POLYCARBOPHIL) TABLET [GENDOSE PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20240504_e7f3b91b-7942-3e0d-e053-2a95a90a34ee.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 37 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation89106733-69f1-469b-9d07-f06ac09b2fb62024-04-02WarningsExact identifier
application number: M007
FLEETMINERAL OILC.B. Fleet Company, Inc.e0b7acab-add4-4daf-b1df-bb7cf5ca8e192024-04-01WarningsExact identifier
application number: M007
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)89dc2063-6744-4412-89be-90990090b57c2024-03-19WarningsExact identifier
application number: M007
Senna LaxativeSENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2322765d-6f08-48d4-a500-818a8a558f6f2024-03-19WarningsExact identifier
application number: M007
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)dcab26ff-2c10-4478-90a8-c89d87261bfa2024-03-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4d1391da-7874-4a51-a468-2843ecf6f92b2024-03-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)adaea845-e029-422d-a947-d8ce8f5787ed2024-03-18WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8b033d56-b95b-4905-9f33-cf2fbd61ce352024-03-15WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCVS Pharmacy6a97a181-1ec2-473d-a588-db2f2f2f662d2024-03-14WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMCVS Pharmacydcd27653-4c81-4630-a8b7-5fb5dc3e976a2024-03-13WarningsExact identifier
application number: M007
EX-LAX REGULAR STRENGTH STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLC62544c2f-6e30-4cec-ae63-233715ef06992024-03-13WarningsExact identifier
application number: M007
Laxative Stool SoftenerDOCUSATE SODIUM, SENNOSIDESCVS Pharmacyb52181e3-fd84-479e-8590-18619f6c0dae2024-03-13WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMCVS Pharmacy5eb047d2-8317-4de3-9268-d206ca039e3d2024-03-13WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacyf77c65b0-3e13-48ce-a2d9-36a9eba1851f2024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy849b057a-dc46-423c-a2f4-b01f135a38032024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE CALCIUMCVS Pharmacycf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf2024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy8d59fa14-fc7c-4146-ba59-c2a907356dd62024-03-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCostco Wholesalea19c20bd-84ff-4931-8312-2fbf0400e8e02024-03-06WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)a1ea0993-2d23-44e3-bc72-e4bf497ab7232024-03-05WarningsExact identifier
application number: M007
Senna LaxativeSENNOSIDESCare One (Retail Business Services, LLC.)a5994303-c9d0-4c6f-8eb7-5f364aa6ed0f2024-03-05WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308934calcium polycarbophil 625 MG Oral TabletPSNe7f3b91b-7942-3e0d-e053-2a95a90a34ee6
308934calcium polycarbophil 625 MG Oral TabletSCDe7f3b91b-7942-3e0d-e053-2a95a90a34ee6
308934calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral TabletSYe7f3b91b-7942-3e0d-e053-2a95a90a34ee6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77333-120-25773330120251 in 1 BLISTER PACKHistorical
77333-120-507733301205050 BLISTER PACK in 1 BOX (77333-120-50) / 1 TABLET in 1 BLISTER PACK (77333-120-25) 50 blister pack2022-09-020000-00-00NoNoCurrent