Home NDC 55289-949 Fiber Lax
Product NDC 55289-949
11-digit product format 552890949
Labeler code 55289
Product ID 55289-949_419b8a9a-2ee8-ef30-e063-6294a90a3e94
Type HUMAN OTC DRUG
Nonproprietary name Calcium Polycarbophil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-09-01
Substance CALCIUM POLYCARBOPHIL
Active strength 625 mg/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 Fiber Lax
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM POLYCARBOPHIL 625 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8F049NKY49 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308934 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 55289-949-30 Fiber Lax 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-949 FIBER LAX (CALCIUM POLYCARBOPHIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20241012_730198a5-b6d9-4fc7-b053-a7c65a93c540.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 17 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-949-30 55289094930 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-949-30) 2021-03-27 0000-00-00 No No Current