FDA.reportPublic FDA data

KALMIA

Product NDC
82969-2524
Requested package NDC
82969-2524-1
11-digit product format
829692524
Labeler code
82969
Product ID
82969-2524_54398635-6533-7831-e063-6394a90a77bb
Type
HUMAN OTC DRUG
Nonproprietary name
arnica montana, chelidonium, colchicum, kalmia, ranunculus bulb, sanguinaria nit, sumbul
Dosage form
LIQUID
Route
ORAL
Labeler
Total Operations Management LLC DBA:Bestmade Natural Products Micro
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-01-01
Substance
FERULA SUMBUL ROOT; RANUNCULUS BULBOSUS ROOT; SANGUINARIA CANADENSIS ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; ARNICA MONTANA; KALMIA LATIFOLIA LEAF
Active strength
10; 10; 7; 7; 7; 6; 6 [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
KALMIA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERULA SUMBUL ROOT10 [hp_X]/mL
RANUNCULUS BULBOSUS ROOT10 [hp_X]/mL
SANGUINARIA CANADENSIS ROOT7 [hp_X]/mL
CHELIDONIUM MAJUS7 [hp_X]/mL
COLCHICUM AUTUMNALE BULB7 [hp_X]/mL
ARNICA MONTANA6 [hp_X]/mL
KALMIA LATIFOLIA LEAF6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GLA4808EHQInternal UNII lookup
XV11P9Y1A1Internal UNII lookup
N9288CD508Internal UNII lookup
7E889U5RNNInternal UNII lookup
993QHL78E6Internal UNII lookup
O80TY208ZWInternal UNII lookup
79N6542N18Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
54396b20-2708-1393-e063-6294a90ad802Available 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
KALMIAARNICA MONTANA, CHELIDONIUM, COLCHICUM, KALMIA, RANUNCULUS BULB, SANGUINARIA NIT, SUMBULTotal Operations Management LLC DBA:Bestmade Natural Products Micro54396b20-2708-1393-e063-6294a90ad8022026-06-14WarningsExact identifier
ndc (package): 82969-2524-1
ndc (product): 82969-2524
ndc11 (package): 82969252401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82969-2524-18296925240130 mL in 1 BOTTLE, GLASS (82969-2524-1) 30 ml2015-01-01NoNoCurrent