FDA.reportPublic FDA data

BM Rescue Remedy (Instant Calm)

Product NDC
85816-6025
11-digit product format
858166025
Labeler code
85816
Product ID
85816-6025_388ff26a-f736-7247-e063-6294a90a2dde
Type
HUMAN OTC DRUG
Nonproprietary name
Clematis erecta, Cherry plum, Impatiens glandulifera, Rock rose, Star of Bethlehem
Dosage form
SPRAY
Route
SUBLINGUAL
Labeler
BM Private Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-01
Substance
HELIANTHEMUM NUMMULARIUM FLOWER; CLEMATIS RECTA FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER
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
2026-12-31
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 Rescue Remedy (Instant Calm)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HELIANTHEMUM NUMMULARIUM FLOWER5 [hp_X]/mL
CLEMATIS RECTA FLOWERING TOP5 [hp_X]/mL
IMPATIENS GLANDULIFERA FLOWER5 [hp_X]/mL
ORNITHOGALUM UMBELLATUM5 [hp_X]/mL
PRUNUS CERASIFERA FLOWER5 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
51BRR32WPPInternal UNII lookup
396421SP9FInternal UNII lookup
AJU5O1A5ZVInternal UNII lookup
9NS3M2Y78SInternal UNII lookup
0KD7R09EASInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
388ff26a-f735-7247-e063-6294a90a2ddeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85816-6025-1BM Rescue Remedy (Instant Calm)30 mL in 1 BOTTLE, SPRAYSPRAY301

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 Rescue Remedy (Instant Calm)CLEMATIS ERECTA, CHERRY PLUM, IMPATIENS GLANDULIFERA, ROCK ROSE, STAR OF BETHLEHEMBM Private Limited388ff26a-f735-7247-e063-6294a90a2dde2025-06-27WarningsExact identifier
ndc (product): 85816-6025

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85816-6025-18581660250130 mL in 1 BOTTLE, SPRAY (85816-6025-1) 30 ml2015-01-01NoNoCurrent