Home NDC 58624-5003 Calcium Polycarbophil
Product NDC 58624-5003
11-digit product format 586245003
Labeler code 58624
Product ID 58624-5003_e7768a51-609b-4d3e-9864-b94ee9ccbdd9
Type HUMAN OTC DRUG
Nonproprietary name Calcium Polycarbophil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler SHANDONG XINHUA PHARMACEUTICAL CO., LTD.
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-12
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 Calcium Polycarbophil
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 58624-5003-1 Calcium Polycarbophil 90 in 1 BOTTLE TABLET, FILM COATED 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58624-5003 CALCIUM POLYCARBOPHIL TABLET, FILM COATED [SHANDONG XINHUA PHARMACEUTICAL CO., LTD.] 7 Current NDC, 1 package rows 20250110_ee06868b-f741-8da2-e053-2a95a90a9772.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 Sample Exclude flag Status 58624-5003-1 58624500301 90 TABLET, FILM COATED in 1 BOTTLE (58624-5003-1) 2023-04-12 No No Current