FDA.reportPublic FDA data

BM BM134 DROPS

Product NDC
85816-2134
Requested package NDC
85816-2134-2
11-digit product format
858162134
Labeler code
85816
Product ID
85816-2134_590234bb-b22f-9ff6-e063-6394a90ab04e
Type
HUMAN OTC DRUG
Nonproprietary name
Arsenic album, Hydrastis, Myristica, Nitric acid, Paeonia, Rhus tox, Silicea
Dosage form
LIQUID
Route
ORAL
Labeler
BM Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-01
Substance
ARSENIC TRIOXIDE; GOLDENSEAL; VIROLA SEBIFERA RESIN; NITRIC ACID; PAEONIA OFFICINALIS ROOT; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE
Active strength
10; 1; 1; 10; 1; 7; 10 [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 BM134 DROPS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE10 [hp_X]/mL
GOLDENSEAL1 [hp_X]/mL
VIROLA SEBIFERA RESIN1 [hp_X]/mL
NITRIC ACID10 [hp_X]/mL
PAEONIA OFFICINALIS ROOT1 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF7 [hp_X]/mL
SILICON DIOXIDE10 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S7V92P67HOInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
GHJ5XX5SGSInternal UNII lookup
411VRN1TV4Internal UNII lookup
8R564U2E1PInternal UNII lookup
6IO182RP7AInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
59023500-89be-cc76-e063-6294a90a6e02Available 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 BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
ndc (package): 85816-2134-2
ndc (product): 85816-2134
ndc11 (package): 85816213402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85816-2134-285816213402500 mL in 1 JAR (85816-2134-2) 500 ml2015-01-01NoNoCurrent