FDA.reportPublic FDA data

SAMS WEST

Product NDC
68196-119
11-digit product format
681960119
Labeler code
68196
Product ID
68196-119_44065bfa-ab34-32ba-e063-6294a90af7d2
Type
HUMAN OTC DRUG
Nonproprietary name
Psyllium Husk
Dosage form
CAPSULE
Route
ORAL
Labeler
SAM'S WEST INC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-21
Substance
PSYLLIUM HUSK
Active strength
.52 g/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
SAMS WEST
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSYLLIUM HUSK.52 g/1

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
581417Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2aaf5d99-6d28-4fa6-b3c5-52dcfc94dac0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-119-40SAMS WEST400 in 1 BOTTLECAPSULE4007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-119SAMS WEST (PSYLLIUM HUSK) CAPSULE [SAM'S WEST INC]6Current NDC, Legacy NDC, 1 package rows20241212_2aaf5d99-6d28-4fa6-b3c5-52dcfc94dac0.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 41 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWal-Mart Stores, Inc.750e0355-369e-b679-e053-2a91aa0a66ca2023-11-01WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWal-Mart Stores, Inc.750efd58-5845-fbc4-e053-2a91aa0a86d12023-11-01WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEWALGREEN COMPANYba4a29b3-2ddc-b906-e053-2995a90a2ab72023-11-01WarningsExact identifier
application number: M007
DOCUZENSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGProficient Rx LP92879e62-f60a-4ab4-9532-610cdd2628ee2023-11-01WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions5999904a-6ac8-4d9e-951c-6e64e8cd93eb2023-11-01WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e98f9d9-679c-63a2-e053-2991aa0a4b8d2023-10-31WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e957b01-4f44-0a2a-e053-2991aa0a37a02023-10-31WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e993b13-8dc8-6653-e053-2a91aa0a4c2a2023-10-31WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDECVS3c8e4144-6702-2678-e054-00144ff88e882023-10-31WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILMagno-Humphries, Inc.9d22c208-d089-8b6a-e053-2995a90ab90a2023-10-27WarningsExact identifier
application number: M007
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.a0e6ab9b-fd31-45fd-93d5-b51d705c180a2023-10-27WarningsExact identifier
application number: M007
Sennosides Natural LaxativeSENNOSIDESMagno-Humphries, Inc.9d22bedb-9fca-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M007
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.9d22d642-8aed-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM, SENNOSIDESMagno-Humphries, Inc.9deaf264-6af0-40ba-e053-2a95a90ada0e2023-10-27WarningsExact identifier
application number: M007
FLEETMINERAL OILC.B. Fleet Company, Inc.2528cb5e-437e-41f0-9c34-e9ce57404d8b2023-10-26WarningsExact identifier
application number: M007
Magnesium CitrateMAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMONMajor Pharmaceuticals088e5543-c947-af78-e063-6294a90a8bc42023-10-25WarningsExact identifier
application number: M007
DOKDOCUSATE SODIUMMAJOR PHARMACEUTICALS7a92070d-98cc-662f-e053-2991aa0aa1b22023-10-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMKROGER COMPANYa1afaa71-7e8c-5a49-e053-2a95a90a4db02023-10-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp644d81ec-d38f-4172-a087-727b94e2fefe2023-10-19WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAsclemed USA, Inc.30fc8c07-c26b-4bcc-a727-6e193f5727fd2023-10-16WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581417psyllium 0.52 GM Oral CapsulePSN2aaf5d99-6d28-4fa6-b3c5-52dcfc94dac07
581417psyllium 520 MG Oral CapsuleSCD2aaf5d99-6d28-4fa6-b3c5-52dcfc94dac07
581417psyllium 0.52 GM Oral CapsuleSY2aaf5d99-6d28-4fa6-b3c5-52dcfc94dac07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-119-4068196011940400 CAPSULE in 1 BOTTLE (68196-119-40) 400 capsule2019-05-210000-00-00NoNoCurrent