FDA.reportPublic FDA data

Premier Value Fiber Therapy

Product NDC
68016-511
11-digit product format
680160511
Labeler code
68016
Product ID
68016-511_1f502a1b-31e4-494e-9620-7c1a248d0684
Type
HUMAN OTC DRUG
Nonproprietary name
Psyllium Husk
Dosage form
POWDER
Route
ORAL
Labeler
PHARMACY VALUE ALLIANCE, LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-20
Substance
PSYLLIUM HUSK
Active strength
3.4 g/7g
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
Premier Value Fiber Therapy
Brand name suffix
Original Coarse
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSYLLIUM HUSK3.4 g/7g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0SHO53407GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
824586Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8c85a13d-ae99-4599-9a28-c3965caa6376Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-511-72Premier Value Fiber TherapyOriginal Coarse538 g in 1 BOTTLE, PLASTICPOWDER5386

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-511PREMIER VALUE FIBER THERAPY ORIGINAL COARSE (PSYLLIUM HUSK) POWDER [PHARMACY VALUE ALLIANCE, LLC]6Current NDC, Legacy NDC, 1 package rows20241030_8c85a13d-ae99-4599-9a28-c3965caa6376.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 8 of 43 · 858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna SyrupNATURAL VEGETABLE LAXATIVEBryant Ranch Prepack2c0d62e7-563b-46e4-9793-183e98e761a62026-03-25WarningsExact identifier
application number: M007
LaxomilBISACODYL 5MGPharmadel LLC3999935b-d8e8-52a6-e063-6294a90aa2a22026-03-20WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGGrocery Outletc820e6a1-fa23-447a-9ee9-50a1bd617adb2026-03-19WarningsExact identifier
application number: M007
CITRUCELMETHYLCELLULOSEHaleon US Holdings LLC9d5f2244-a610-4d45-b6e8-e79bb17a558f2026-03-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMSafeway, Inc.f178b31d-4843-4b91-a0d5-ab5ade835dc22026-03-16WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMSafeway, Inc.12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c2026-03-13WarningsExact identifier
application number: M007
Castor OilCASTOR OILOld East Main Co.a1ca668a-3bf9-46a9-8a4f-5cb61547bb812026-03-12Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILVi-Jon, LLCb29775df-8470-4fe3-bee3-f0490ea6903f2026-03-12WarningsExact identifier
application number: M007
Castor OilCASTOR OILNice-Pak Products, LLCcc43d514-ee82-4314-99b2-c64380f987792026-03-12Warnings, Adverse reactionsExact identifier
application number: M007
FiberconCALCIUM POLYCARBOPHILFoundation Consumer Brands7992a4bb-5535-4a1d-867d-a99f7e0c1be72026-03-12WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWalgreenscda27a9c-9175-4b07-9c0b-d8d8978829652026-03-12WarningsExact identifier
application number: M007
Magnesium Citrate Saline Laxative - Lemon FlavorMAGNESIUM CITRATEUniversal Distribution Center LLCaa02c9af-22b8-4ec2-9e43-fe073f5e617b2026-03-11WarningsExact identifier
application number: M007
Magnesium Citrate Saline Laxative - Grape FlavorMAGNESIUM CITRATEUniversal Distribution Center LLC021ebb61-2466-4272-8f7d-b49cafd087542026-03-11WarningsExact identifier
application number: M007
Magnesium Citrate Saline Laxative - Cherry FlavorMAGNESIUM CITRATEUniversal Distribution Center LLC1f14411b-6833-40e6-b1a5-2b8c5bf709d32026-03-11WarningsExact identifier
application number: M007
CitromaMAGNESIUM CITRATEUpLift Brands, LLCf83ba007-734d-4910-87cb-02e45285e1612026-03-11Warnings, Adverse reactionsExact identifier
application number: M007
CitromaMAGNESIUM CITRATEUpLift Brands, LLC57e914fa-8fa2-4221-bb5f-534f0ea0aba72026-03-11Warnings, Adverse reactionsExact identifier
application number: M007
CitromaMAGNESIUM CITRATEUpLift Brands, LLCf28a9043-e0ee-4b38-95d9-d3f23d4006912026-03-11Warnings, Adverse reactionsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAmerisource Bergen4caf0bcb-c1bf-0ae7-e063-6294a90a344b2026-03-10WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWalgreens92df761b-da68-4ce9-b02a-a5a74fd6620e2026-03-10WarningsExact identifier
application number: M007
FleetGLYCERINC.B. Fleet Company, Inc.31778652-e60e-4098-8e90-3e4f56b5800c2026-03-06WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
824586psyllium 3.4 GM Powder for Oral SuspensionPSN8c85a13d-ae99-4599-9a28-c3965caa63766
824586psyllium 3400 MG Powder for Oral SuspensionSCD8c85a13d-ae99-4599-9a28-c3965caa63766
824586psyllium 3.4 GM Powder for Oral SuspensionSY8c85a13d-ae99-4599-9a28-c3965caa63766

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-511-7268016051172538 g in 1 BOTTLE, PLASTIC (68016-511-72) 538 g2019-05-200000-00-00NoNoCurrent