FDA.reportPublic FDA data

Premier Value

Product NDC
68016-551
11-digit product format
680160551
Labeler code
68016
Product ID
68016-551_1110b9a6-17c6-4208-bc68-765156d81621
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
2019-04-10
Substance
PSYLLIUM HUSK
Active strength
3.4 g/5.8g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Brand name suffix
Orange Flavor
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSYLLIUM HUSK3.4 g/5.8g

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
2d580965-2bef-46ee-8532-fbe34330a4b4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-551-14Premier ValueOrange Flavor660 g in 1 BOTTLE, PLASTICPOWDER6606
68016-551-72Premier ValueOrange Flavor425 g in 1 BOTTLE, PLASTICPOWDER4256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-551PREMIER VALUE ORANGE FLAVOR (PSYLLIUM HUSK) POWDER [PHARMACY VALUE ALLIANCE, LLC]6Current NDC, Legacy NDC, 2 package rows20241030_2d580965-2bef-46ee-8532-fbe34330a4b4.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 40 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Milk of Magnesia mintMAGNESIUM HYDROXIDEMeijer, Inc.bb8ba371-f53c-1088-e053-2a95a90a4cbf2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDESTRATEGIC SOURCING SERVICES LLC00c61622-367b-0a5b-e063-6294a90a67062023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEStrategic Sourcing Services LLC003a3c0d-7a48-e44d-e063-6394a90a3f4a2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corp2d1be236-e136-4727-a52d-714f628800882023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEAMERISOURCEBERGEN DRUG CORPORATION5d690d82-e4fb-57ad-e053-2a91aa0a38ea2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEAMERISOURCEBERGEN DRUG CORPORATION5d6a8048-93e7-42e5-e053-2991aa0acabd2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEAMERISOURCEBERGEN DRUG CORPORATION5d7f5a38-4222-5bfb-e053-2991aa0a17e32023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDECARDINAL HEALTHaf4b6b64-97c9-a794-e053-2a95a90aaf0b2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDECARDINAL HEALTHaf5ddf5d-b1f5-2918-e053-2995a90a2d612023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEH E Bab998776-6b30-9f17-e053-2995a90a96cd2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEH E Babfe89c8-86f1-bd1e-e053-2995a90af7732023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEGOODSENSEa951617d-c6fa-75e0-e053-2995a90afcf82023-11-07WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEKROGER COMPANYa1b04366-ff67-3bb3-e053-2a95a90a816c2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEBETTER LIVING BRANDS, LLCb9440381-df40-4bc7-e053-2995a90ae83f2023-11-07WarningsExact identifier
application number: M007
Milk of Magnesia mintMAGNESIUM HYDROXIDETOP CARE (TOPCO ASSOCIATES LLC)b83f6027-51a0-1730-e053-2995a90a553b2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDETOP CARE (TOPCO ASSOCIATES LLC)b83eb807-d522-4408-e053-2a95a90a79262023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDETOP CARE (TOPCO ASSOCIATES LLC)b83f0c1c-0e90-2888-e053-2995a90a0b962023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEDOLGENCORP, INC.b6991abf-9819-701c-e053-2a95a90ac0b42023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEChain Drug Marketing Association7722145c-913c-4ed5-a9b2-a6c3430640662023-11-06WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEChain Drug Marketing Association12361478-d178-4950-9458-4e2e565655992023-11-06WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
824586psyllium 3.4 GM Powder for Oral SuspensionPSN2d580965-2bef-46ee-8532-fbe34330a4b46
824586psyllium 3400 MG Powder for Oral SuspensionSCD2d580965-2bef-46ee-8532-fbe34330a4b46
824586psyllium 3.4 GM Powder for Oral SuspensionSY2d580965-2bef-46ee-8532-fbe34330a4b46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-551-1468016055114660 g in 1 BOTTLE, PLASTIC (68016-551-14) 660 g2019-04-100000-00-00NoNoCurrent
68016-551-7268016055172425 g in 1 BOTTLE, PLASTIC (68016-551-72) 425 g2019-04-100000-00-00NoNoCurrent