FDA.reportPublic FDA data

BM VITAGENE FORTE DROPS

Product NDC
85816-6007
Requested package NDC
85816-6007-2
11-digit product format
858166007
Labeler code
85816
Product ID
85816-6007_544d3750-6703-e548-e063-6394a90a5e74
Type
HUMAN OTC DRUG
Nonproprietary name
Acid Phos, Agnus Castus, Caladium seg, Damiana, Ginseng Panax, Sabal Serr, Scutellaria Lat, Selenium, Yohimbinum
Dosage form
LIQUID
Route
ORAL
Labeler
BM Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-01
Substance
CHASTE TREE FRUIT; SELENIUM; TURNERA DIFFUSA LEAFY TWIG; SAW PALMETTO; DIEFFENBACHIA SEGUINE WHOLE; PHOSPHORIC ACID; AMERICAN GINSENG; YOHIMBINE; SCUTELLARIA LATERIFLORA WHOLE
Active strength
4; 8; 6; 2; 1; 7; 2; 3; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [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 VITAGENE FORTE DROPS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHASTE TREE FRUIT4 [hp_X]/mL
SELENIUM8 [hp_X]/mL
TURNERA DIFFUSA LEAFY TWIG6 [hp_X]/mL
SAW PALMETTO2 [hp_X]/mL
DIEFFENBACHIA SEGUINE WHOLE1 [hp_X]/mL
PHOSPHORIC ACID7 [hp_X]/mL
AMERICAN GINSENG2 [hp_X]/mL
YOHIMBINE3 [hp_X]/mL
SCUTELLARIA LATERIFLORA WHOLE2 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
433OSF3U8AInternal UNII lookup
H6241UJ22BInternal UNII lookup
RQ2CFA7WWJInternal UNII lookup
J7WWH9M8QSInternal UNII lookup
01800C6E6BInternal UNII lookup
E4GA8884NNInternal UNII lookup
8W75VCV53QInternal UNII lookup
2Y49VWD90QInternal UNII lookup
7BP4DH5PDCInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
544d11cd-3cfa-9c91-e063-6294a90a8526Available 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 VITAGENE FORTE DROPSACID PHOS, AGNUS CASTUS, CALADIUM SEG, DAMIANA, GINSENG PANAX, SABAL SERR, SCUTELLARIA LAT, SELENIUM, YOHIMBINUMBM Private Limited544d11cd-3cfa-9c91-e063-6294a90a85262026-06-15WarningsExact identifier
ndc (package): 85816-6007-2
ndc (product): 85816-6007
ndc11 (package): 85816600702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85816-6007-285816600702500 mL in 1 JAR (85816-6007-2) 500 ml2015-01-01NoNoCurrent