FDA.reportPublic FDA data

BM BM53 DROPS

Product NDC
85816-2053
Requested package NDC
85816-2053-2
11-digit product format
858162053
Labeler code
85816
Product ID
85816-2053_58eeb0f6-7f54-ba72-e063-6394a90a6a08
Type
HUMAN OTC DRUG
Nonproprietary name
Apis mellifica, Apium virus, Arsenic alb., Bryonia alba, Sulphur
Dosage form
LIQUID
Route
ORAL
Labeler
BM Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-01
Substance
APIS MELLIFERA; APIS MELLIFERA VENOM; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; SULFUR
Active strength
6; 12; 30; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
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 BM53 DROPS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIS MELLIFERA6 [hp_X]/mL
APIS MELLIFERA VENOM12 [hp_X]/mL
ARSENIC TRIOXIDE30 [hp_X]/mL
BRYONIA ALBA ROOT6 [hp_X]/mL
SULFUR12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7S82P3R43ZInternal UNII lookup
76013O881MInternal UNII lookup
S7V92P67HOInternal UNII lookup
T7J046YI2BInternal UNII lookup
70FD1KFU70Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
58eeb0eb-d09a-b979-e063-6394a90ad84dAvailable 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 BM53 DROPSAPIS MELLIFICA, APIUM VIRUS, ARSENIC ALB., BRYONIA ALBA, SULPHURBM Private Limited58eeb0eb-d09a-b979-e063-6394a90ad84d2026-08-13WarningsExact identifier
ndc (package): 85816-2053-2
ndc (product): 85816-2053
ndc11 (package): 85816205302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85816-2053-285816205302500 mL in 1 JAR (85816-2053-2) 500 ml2015-01-01NoNoCurrent