Home NDC 55758-418 Dr. Fibra
Product NDC 55758-418
11-digit product format 557580418
Labeler code 55758
Product ID 55758-418_1ddc7cb3-05e6-6453-e063-6294a90a620a
Type HUMAN OTC DRUG
Nonproprietary name Psyllium Husk
Dosage form POWDER
Route ORAL
Labeler Pharmadel LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-30
Substance PSYLLIUM HUSK
Active strength 3.4 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 Dr. Fibra
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PSYLLIUM HUSK 3.4 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 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 55758-418-10 Dr. Fibra 10 in 1 BOX POWDER 10 2 55758-418-10 Dr. Fibra 1 in 1 PACKET POWDER 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-418 DR. FIBRA (PSYLLIUM HUSK) POWDER [PHARMADEL LLC] 2 Current NDC, 2 package rows 20240724_1a6151c9-e1c4-f0c1-e063-6394a90aad24.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 30 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 Sample Exclude flag Status 55758-418-10 55758041810 10 PACKET in 1 BOX (55758-418-10) / 1 POWDER in 1 PACKET 10 packet 2024-06-30 No No Current