FDA.reportPublic FDA data

BM BM164 DROPS

Product NDC
85816-2164
Requested package NDC
85816-2164-2
11-digit product format
858162164
Labeler code
85816
Product ID
85816-2164_59027719-c781-d12a-e063-6394a90a2fb1
Type
HUMAN OTC DRUG
Nonproprietary name
Arum tryph, Causticum, Balsamum peru, Helonias Dio, Acid phos, Glycerinum, Equisetum
Dosage form
LIQUID
Route
ORAL
Labeler
BM Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-01
Substance
ARISAEMA TRIPHYLLUM ROOT; CAUSTICUM; BALSAM PERU; CHAMAELIRIUM LUTEUM ROOT; PHOSPHORIC ACID; GLYCERIN; EQUISETUM HYEMALE WHOLE
Active strength
100; 100; 100; 70; 100; 100; 100 [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], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], 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 BM164 DROPS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARISAEMA TRIPHYLLUM ROOT100 [hp_X]/mL
CAUSTICUM100 [hp_X]/mL
BALSAM PERU100 [hp_X]/mL
CHAMAELIRIUM LUTEUM ROOT70 [hp_X]/mL
PHOSPHORIC ACID100 [hp_X]/mL
GLYCERIN100 [hp_X]/mL
EQUISETUM HYEMALE WHOLE100 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DM64K844DMInternal UNII lookup
DD5FO1WKFUInternal UNII lookup
8P5F881OCYInternal UNII lookup
DQV54Y5H3UInternal UNII lookup
E4GA8884NNInternal UNII lookup
PDC6A3C0OXInternal UNII lookup
59677RXH25Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5902770f-eb01-d099-e063-6394a90ad3ebAvailable 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 BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
ndc (package): 85816-2164-2
ndc (product): 85816-2164
ndc11 (package): 85816216402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85816-2164-285816216402500 mL in 1 JAR (85816-2164-2) 500 ml2015-01-01NoNoCurrent