Home NDC 87587-250 CrystLCare Regeneration Plus
Product NDC 87587-250
11-digit product format 875870250
Labeler code 87587
Product ID 87587-250_4f86d0a0-d73f-5605-e063-6394a90adb38
Type HUMAN OTC DRUG
Nonproprietary name Potassium Nitrate, Sodium Fluoride
Dosage form FILM, SOLUBLE
Route ORAL
Labeler GreenMark Biomedical Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-09-14
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 50; .2 mg/1000mg; mg/1000mg
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 CrystLCare Regeneration Plus
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 50 mg/1000mg SODIUM FLUORIDE .2 mg/1000mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RU45X2JN0Z Internal UNII lookup 8ZYQ1474W7 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 29 of 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87587-250-01 87587025001 14 POUCH in 1 CARTON (87587-250-01) / 150 mg in 1 POUCH (87587-250-50) 14 pouch 2026-09-14 No No Current