Home NDC 68016-551 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 Ingredient Strength PSYLLIUM HUSK 3.4 g/5.8g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0SHO53407G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 824586 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68016-551-14 Premier ValueOrange Flavor 660 g in 1 BOTTLE, PLASTIC POWDER 660 6 68016-551-72 Premier ValueOrange Flavor 425 g in 1 BOTTLE, PLASTIC POWDER 425 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-551 PREMIER VALUE ORANGE FLAVOR (PSYLLIUM HUSK) POWDER [PHARMACY VALUE ALLIANCE, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241030_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 14 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68016-551-14 68016055114 660 g in 1 BOTTLE, PLASTIC (68016-551-14) 660 g 2019-04-10 0000-00-00 No No Current 68016-551-72 68016055172 425 g in 1 BOTTLE, PLASTIC (68016-551-72) 425 g 2019-04-10 0000-00-00 No No Current