FDA.reportPublic FDA data

BM BM16 DROPS

Product NDC
85816-2301
Requested package NDC
85816-2301-2
11-digit product format
858162301
Labeler code
85816
Product ID
85816-2301_55b70549-b883-df23-e063-6294a90a41d1
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica Mont, Cactus Grand, Crataegus Oxy, Spigelia, Valeriana
Dosage form
LIQUID
Route
ORAL
Labeler
BM Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-01
Substance
SPIGELIA MARILANDICA ROOT; SELENICEREUS GRANDIFLORUS STEM; ARNICA MONTANA WHOLE; CRATAEGUS LAEVIGATA FRUIT; VALERIAN
Active strength
2; 1; 4; 1; 2 [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 BM16 DROPS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPIGELIA MARILANDICA ROOT2 [hp_X]/mL
SELENICEREUS GRANDIFLORUS STEM1 [hp_X]/mL
ARNICA MONTANA WHOLE4 [hp_X]/mL
CRATAEGUS LAEVIGATA FRUIT1 [hp_X]/mL
VALERIAN2 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
467D26HS0BInternal UNII lookup
7114SV0MYKInternal UNII lookup
O80TY208ZWInternal UNII lookup
D5RZ7MF1YFInternal UNII lookup
JWF5YAW3QWInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
55b70ae1-e12c-df21-e063-6294a90a78d5Available 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 BM16 DROPSARNICA MONT, CACTUS GRAND, CRATAEGUS OXY, SPIGELIA, VALERIANABM Private Limited55b70ae1-e12c-df21-e063-6294a90a78d52026-07-03WarningsExact identifier
ndc (package): 85816-2301-2
ndc (product): 85816-2301
ndc11 (package): 85816230102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85816-2301-285816230102500 mL in 1 JAR (85816-2301-2) 500 ml2015-01-01NoNoCurrent