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 16 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna-SDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGWalgreens36cc3a5b-1891-d39e-e063-6294a90a93b42025-12-31WarningsExact identifier
application number: M007
Senna LiquidSENNOSIDESRUGBY LABORATORIES8123b092-2ae9-459b-ae06-6ceb837adcf82025-12-30WarningsExact identifier
application number: M007
Docusate Sodium LiquidDOCUSATE SODIUMRUGBY LABORATORIESe21d19d8-6c2d-4474-a663-dfe7e91ac3202025-12-30WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDERUGBY LABORATORIESb1bafa6e-0f54-1c35-e053-2995a90a42e42025-12-30WarningsExact identifier
application number: M007
OneLAX SENNASENNAATLANTIC BIOLOGICALS CORP.d2a5a13a-e7e4-488a-b60b-4dd467efa9712025-12-29WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESLlorens Pharmaceutical International Division, Inc.5be0163c-b7f7-46db-b738-78c2946a6cf62025-12-29WarningsExact identifier
application number: M007
SenokotSTANDARDIZED SENNA CONCENTRATEAtlantis Consumer Healthcare, Inc.c18dd7fa-993b-440b-8cdd-f1551abb99ca2025-12-29WarningsExact identifier
application number: M007
LAXATIVEBISACODYLGRAXCELL PHARMACEUTICAL, LLC5a65d4ab-447f-42bb-b38d-070db523b8062025-12-25WarningsExact identifier
application number: M007
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGPharbest Pharmaceuticals, Inc.2b5152b2-d354-409f-a19f-b470f4181b3f2025-12-24WarningsExact identifier
application number: M007
Senna TabsSENNAPharbest Pharmaceuticals, Inc.b9f8ea59-932f-4827-a87c-b4aff909c43f2025-12-24WarningsExact identifier
application number: M007
Senna PlusDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGCARDINAL HEALTH, 110 DBA LEADER4d4101ca-7d78-4712-9b3d-f395f2646c6b2025-12-23WarningsExact identifier
application number: M007
Equate Gentle Laxative Soft chewMAGNESIUM HYDROXIDEWalmart0997c1b7-16db-7db7-e063-6294a90a59282025-12-23WarningsExact identifier
application number: M007
Equate Kids Gentle Laxative SCMAGNESIUM HYDROXIDEWalmart1662a542-aef0-9087-e063-6294a90aa6d92025-12-23WarningsExact identifier
application number: M007
AMAZON FIBER CAPLETSCALCIUM POLYCARBOPHILAMAZON.COM SERVICES LLC178f4150-c75c-45e1-a5f3-3af67b5c81092025-12-22WarningsExact identifier
application number: M007
AMAZON FIBER THERAPYMETHYLCELLULOSEAMAZON.COM SERVICES LLC3eee7b21-5401-4ef1-b1c6-1013439639d22025-12-22WarningsExact identifier
application number: M007
SennosidesSENNOSIDESGranules USA Inca619b8f4-1b5d-181b-e053-2995a90ab7292025-12-22WarningsExact identifier
application number: M007
CAREALL SennosidesSENNOSIDESNew World Imports, Inc61bbbb6a-9997-4df1-94be-a80686d1f1b92025-12-22WarningsExact identifier
application number: M007
Walgreens Blueberry Raspberry Gentle LaxativeMAGNESIUM HYDROXIDEWalgreend35f1518-bc63-83eb-e053-2995a90ae4bb2025-12-21WarningsExact identifier
application number: M007
SennosidesSENNOSIDESWalgreens Co85a2f7ed-315e-2403-e053-2991aa0abdce2025-12-19WarningsExact identifier
application number: M007
SennosidesSENNOSIDESH E Ba5652d5b-43fd-5bfa-e053-2995a90aad6c2025-12-19WarningsExact 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