FDA.reportPublic FDA data

BM BM165 DROPS

Product NDC
85816-2165
Requested package NDC
85816-2165-2
11-digit product format
858162165
Labeler code
85816
Product ID
85816-2165_590301da-8f94-3b1e-e063-6394a90a1e72
Type
HUMAN OTC DRUG
Nonproprietary name
Angelica Atro, Balsam Per, Barium Mur, Grindelia, Kali Bich, Kali Iod, Kali Mur, Silphium Lac
Dosage form
LIQUID
Route
ORAL
Labeler
BM Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-01
Substance
ANGELICA ATROPURPUREA ROOT; BALSAM PERU; BARIUM CHLORIDE DIHYDRATE; GRINDELIA HIRSUTULA WHOLE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; POTASSIUM CHLORIDE; SILPHIUM LACINIATUM WHOLE
Active strength
7; 1; 6; 7; 6; 6; 6; 6 [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
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [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 BM165 DROPS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANGELICA ATROPURPUREA ROOT7 [hp_X]/mL
BALSAM PERU1 [hp_X]/mL
BARIUM CHLORIDE DIHYDRATE6 [hp_X]/mL
GRINDELIA HIRSUTULA WHOLE7 [hp_X]/mL
POTASSIUM DICHROMATE6 [hp_X]/mL
POTASSIUM IODIDE6 [hp_X]/mL
POTASSIUM CHLORIDE6 [hp_X]/mL
SILPHIUM LACINIATUM WHOLE6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
885452N0GZInternal UNII lookup
8P5F881OCYInternal UNII lookup
EL5GJ3U77EInternal UNII lookup
C08B09D8UJInternal UNII lookup
T4423S18FMInternal UNII lookup
1C4QK22F9JInternal UNII lookup
660YQ98I10Internal UNII lookup
NKI8W09136Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
590301da-8f93-3b1e-e063-6394a90a1e72Available 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 BM165 DROPSANGELICA ATRO, BALSAM PER, BARIUM MUR, GRINDELIA, KALI BICH, KALI IOD, KALI MUR, SILPHIUM LACBM Private Limited590301da-8f93-3b1e-e063-6394a90a1e722026-08-14WarningsExact identifier
ndc (package): 85816-2165-2
ndc (product): 85816-2165
ndc11 (package): 85816216502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85816-2165-285816216502500 mL in 1 JAR (85816-2165-2) 500 ml2015-01-01NoNoCurrent