FDA.reportPublic FDA data

BM INSTANT CALM DROPS

Product NDC
85816-6006
Requested package NDC
85816-6006-1
11-digit product format
858166006
Labeler code
85816
Product ID
85816-6006_590af659-c87a-fca6-e063-6394a90af135
Type
HUMAN OTC DRUG
Nonproprietary name
Clematis Erecta, Prunus Cerasifera, Impatiens Glandulifera, Helianthemum Nummularium, Ornithogalum Umbellatum
Dosage form
LIQUID
Route
ORAL
Labeler
BM Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-01
Substance
CLEMATIS RECTA FLOWERING TOP; PRUNUS CERASIFERA FLOWER; IMPATIENS GLANDULIFERA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP
Active strength
5; 5; 5; 5; 5 [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 INSTANT CALM DROPS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLEMATIS RECTA FLOWERING TOP5 [hp_X]/mL
PRUNUS CERASIFERA FLOWER5 [hp_X]/mL
IMPATIENS GLANDULIFERA FLOWER5 [hp_X]/mL
HELIANTHEMUM NUMMULARIUM FLOWER5 [hp_X]/mL
ORNITHOGALUM UMBELLATUM FLOWERING TOP5 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
396421SP9FInternal UNII lookup
0KD7R09EASInternal UNII lookup
AJU5O1A5ZVInternal UNII lookup
51BRR32WPPInternal UNII lookup
CZD6M4PY4BInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
590af4c2-7761-5d2b-e063-6294a90a2afaAvailable 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 INSTANT CALM DROPSCLEMATIS ERECTA, PRUNUS CERASIFERA, IMPATIENS GLANDULIFERA, HELIANTHEMUM NUMMULARIUM, ORNITHOGALUM UMBELLATUMBM Private Limited590af4c2-7761-5d2b-e063-6294a90a2afa2026-08-14WarningsExact identifier
ndc (package): 85816-6006-1
ndc (product): 85816-6006
ndc11 (package): 85816600601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85816-6006-18581660060130 mL in 1 BOTTLE, GLASS (85816-6006-1) 30 ml2015-01-01NoNoCurrent