FDA.reportPublic FDA data

BM BM19 DROPS

Product NDC
85816-2019
Requested package NDC
85816-2019-1
11-digit product format
858162019
Labeler code
85816
Product ID
85816-2019_53f78460-09bb-e41c-e063-6394a90a0423
Type
HUMAN OTC DRUG
Nonproprietary name
Adonis Vern., Calc. Carb. H., Fucus Ves, Graphite, Phytolacca Ber
Dosage form
LIQUID
Route
ORAL
Labeler
BM Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-01
Substance
PHYTOLACCA AMERICANA ROOT; FUCUS VESICULOSUS; ADONIS VERNALIS WHOLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE
Active strength
2; 1; 3; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
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 BM19 DROPS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHYTOLACCA AMERICANA ROOT2 [hp_X]/mL
FUCUS VESICULOSUS1 [hp_X]/mL
ADONIS VERNALIS WHOLE3 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]/mL
GRAPHITE10 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
11E6VI8VEGInternal UNII lookup
535G2ABX9MInternal UNII lookup
DX3ZNI25WKInternal UNII lookup
2E32821G6IInternal UNII lookup
4QQN74LH4OInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53f78460-09ba-e41c-e063-6394a90a0423Available 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 BM19 DROPSADONIS VERN., CALC. CARB. H., FUCUS VES, GRAPHITE, PHYTOLACCA BERBM Private Limited53f78460-09ba-e41c-e063-6394a90a04232026-06-11WarningsExact identifier
ndc (package): 85816-2019-1
ndc (product): 85816-2019
ndc11 (package): 85816201901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85816-2019-18581620190130 mL in 1 BOTTLE, GLASS (85816-2019-1) 30 ml2015-01-01NoNoCurrent