Home NDC 85816-6010 BM Tooth Remineralization
Product NDC 85816-6010
11-digit product format 858166010
Labeler code 85816
Product ID 85816-6010_5331dc40-2ac9-5fce-e063-6394a90a5875
Type HUMAN OTC DRUG
Nonproprietary name Calc Phos, Calc Fluor, Silicea
Dosage form GLOBULE
Route ORAL
Labeler BM Private Limited
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2026-01-01
Substance SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM FLUORIDE
Active strength 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g
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 BM Tooth Remineralization
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SILICON DIOXIDE 12 [hp_X]/g TRIBASIC CALCIUM PHOSPHATE 12 [hp_X]/g CALCIUM FLUORIDE 12 [hp_X]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ETJ7Z6XBU4 Internal UNII lookup 91D9GV0Z28 Internal UNII lookup O3B55K4YKI Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85816-6010-1 85816601001 25 g in 1 BOTTLE, GLASS (85816-6010-1) 25 g 2026-01-01 No No Current 85816-6010-2 85816601002 500 g in 1 JAR (85816-6010-2) 500 g 2026-01-01 No No Current