Home NDC 68163-119 fiber laxative
Product NDC 68163-119
11-digit product format 681630119
Labeler code 68163
Product ID 68163-119_38166795-85d9-49ad-8ffd-77cf84173779
Type HUMAN OTC DRUG
Nonproprietary name Psyllium Husk
Dosage form CAPSULE
Route ORAL
Labeler Raritan Pharmaceuticals Inc
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-04-16
Substance PSYLLIUM HUSK
Active strength .52 g/1
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 fiber laxative
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PSYLLIUM HUSK .52 g/1
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 581417 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68163-119-25 fiber laxative 25 in 1 BOTTLE CAPSULE 25 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68163-119 FIBER LAXATIVE (PSYLLIUM HUSK) CAPSULE [RARITAN PHARMACEUTICALS INC] 6 Current NDC, Legacy NDC, 1 package rows 20241123_22e927bd-5734-424e-8870-1aaa18f1265e.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 · 829 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 68163-119-25 68163011925 25 CAPSULE in 1 BOTTLE (68163-119-25) 25 capsule 2019-04-16 0000-00-00 No No Current