FDA.reportPublic FDA data

BM BIO28 ALCOHOL

Product NDC
85816-9028
Requested package NDC
85816-9028-1
11-digit product format
858169028
Labeler code
85816
Product ID
85816-9028_53d1d98a-b6a6-d228-e063-6394a90a10be
Type
HUMAN OTC DRUG
Nonproprietary name
CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA
Dosage form
LIQUID
Route
ORAL
Labeler
BM Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-01
Substance
TRIBASIC CALCIUM PHOSPHATE; POTASSIUM CHLORIDE; SILICON DIOXIDE; CALCIUM FLUORIDE; SODIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM SULFATE; POTASSIUM PHOSPHATE, DIBASIC; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM CHLORIDE
Active strength
12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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 BIO28 ALCOHOL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIBASIC CALCIUM PHOSPHATE12 [hp_X]/mL
POTASSIUM CHLORIDE12 [hp_X]/mL
SILICON DIOXIDE12 [hp_X]/mL
CALCIUM FLUORIDE12 [hp_X]/mL
SODIUM SULFATE12 [hp_X]/mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]/mL
POTASSIUM SULFATE12 [hp_X]/mL
POTASSIUM PHOSPHATE, DIBASIC12 [hp_X]/mL
CALCIUM SULFATE ANHYDROUS12 [hp_X]/mL
FERROSOFERRIC PHOSPHATE12 [hp_X]/mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE12 [hp_X]/mL
SODIUM CHLORIDE12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
91D9GV0Z28Internal UNII lookup
660YQ98I10Internal UNII lookup
ETJ7Z6XBU4Internal UNII lookup
O3B55K4YKIInternal UNII lookup
0YPR65R21JInternal UNII lookup
HF539G9L3QInternal UNII lookup
1K573LC5TVInternal UNII lookup
CI71S98N1ZInternal UNII lookup
E934B3V59HInternal UNII lookup
91GQH8I5F7Internal UNII lookup
70WT22SF4BInternal UNII lookup
451W47IQ8XInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
53d1c51a-77eb-bb3c-e063-6394a90aab3fAvailable on FDA.report

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
ndc (package): 85816-9028-1
ndc (product): 85816-9028
ndc11 (package): 85816902801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85816-9028-18581690280130 mL in 1 BOTTLE, GLASS (85816-9028-1) 30 ml2015-01-01NoNoCurrent