FDA.reportPublic FDA data

BM BIO18

Product NDC
85816-3018
11-digit product format
858163018
Labeler code
85816
Product ID
85816-3018_4d269a3b-18bb-3ad2-e063-6294a90a1fae
Type
HUMAN OTC DRUG
Nonproprietary name
Calc fluor, Calc sulf, Silicea.
Dosage form
GLOBULE
Route
ORAL
Labeler
BM Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-01
Substance
CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; SILICON DIOXIDE
Active strength
3; 3; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
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 BIO18
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM FLUORIDE3 [hp_X]/g
CALCIUM SULFATE ANHYDROUS3 [hp_X]/g
SILICON DIOXIDE6 [hp_X]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O3B55K4YKIInternal UNII lookup
E934B3V59HInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d269a3b-18ba-3ad2-e063-6294a90a1faeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85816-3018-1BM BIO1825 g in 1 BOTTLE, GLASSGLOBULE251
85816-3018-2BM BIO18500 g in 1 JARGLOBULE5001

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 BIO18CALC FLUOR, CALC SULF, SILICEA.BM Private Limited4d269a3b-18ba-3ad2-e063-6294a90a1fae2026-03-16WarningsExact identifier
ndc (product): 85816-3018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85816-3018-18581630180125 g in 1 BOTTLE, GLASS (85816-3018-1) 25 g2015-01-01NoNoCurrent
85816-3018-285816301802500 g in 1 JAR (85816-3018-2) 500 g2015-01-01NoNoCurrent