FDA.reportPublic FDA data

BM BM13

Product NDC
85816-7013
Requested package NDC
85816-7013-1
11-digit product format
858167013
Labeler code
85816
Product ID
85816-7013_53d4572c-52cf-99a9-e063-6294a90a30e8
Type
HUMAN OTC DRUG
Nonproprietary name
Belladonna, Cuprum Aceticum, Drosera, Grindelia, Ipecac, Lobelia Inflata, Naphthalinum, Yerba Santa
Dosage form
GLOBULE
Route
ORAL
Labeler
BM Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-01-01
Substance
ERIODICTYON CALIFORNICUM LEAF; IPECAC; LOBELIA INFLATA WHOLE; ATROPA BELLADONNA; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA WHOLE; GRINDELIA HIRSUTULA FLOWERING TOP; NAPHTHALENE
Active strength
4; 5; 2; 4; 6; 3; 4; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
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 BM13
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERIODICTYON CALIFORNICUM LEAF4 [hp_X]/g
IPECAC5 [hp_X]/g
LOBELIA INFLATA WHOLE2 [hp_X]/g
ATROPA BELLADONNA4 [hp_X]/g
CUPRIC ACETATE6 [hp_X]/g
DROSERA ROTUNDIFOLIA WHOLE3 [hp_X]/g
GRINDELIA HIRSUTULA FLOWERING TOP4 [hp_X]/g
NAPHTHALENE12 [hp_X]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2Y7TIQ135HInternal UNII lookup
62I3C8233LInternal UNII lookup
9PP1T3TC5UInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
39M11XPH03Internal UNII lookup
QR44N9XPJQInternal UNII lookup
IDB0NAZ6AIInternal UNII lookup
2166IN72UNInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53d42d09-d85e-64ee-e063-6294a90ab8ffAvailable 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 BM13BELLADONNA, CUPRUM ACETICUM, DROSERA, GRINDELIA, IPECAC, LOBELIA INFLATA, NAPHTHALINUM, YERBA SANTABM Private Limited53d42d09-d85e-64ee-e063-6294a90ab8ff2026-06-09WarningsExact identifier
ndc (package): 85816-7013-1
ndc (product): 85816-7013
ndc11 (package): 85816701301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85816-7013-18581670130125 g in 1 BOTTLE, GLASS (85816-7013-1) 25 g2025-01-01NoNoCurrent