Home NDC 85816-2224 KALMIA
Product NDC 85816-2224
11-digit product format 858162224
Labeler code 85816
Product ID 85816-2224_4ae54ad9-2650-428a-e063-6294a90ab87c
Type HUMAN OTC DRUG
Nonproprietary name arnica montana, chelidonium, colchicum, kalmia, ranunculus bulb, sanguinaria nit, sumbul
Dosage form LIQUID
Route ORAL
Labeler BM Private Limited
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 Ingredient Strength FERULA SUMBUL ROOT 10 [hp_X]/mL RANUNCULUS BULBOSUS ROOT 10 [hp_X]/mL SANGUINARIA CANADENSIS ROOT 7 [hp_X]/mL CHELIDONIUM MAJUS 7 [hp_X]/mL COLCHICUM AUTUMNALE BULB 7 [hp_X]/mL ARNICA MONTANA 6 [hp_X]/mL KALMIA LATIFOLIA LEAF 6 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 7 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85816-2224-1 KALMIA 30 mL in 1 BOTTLE, GLASS LIQUID 30 2 85816-2224-2 KALMIA 500 mL in 1 BOTTLE, GLASS LIQUID 500 2
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join KALMIA ARNICA MONTANA, CHELIDONIUM, COLCHICUM, KALMIA, RANUNCULUS BULB, SANGUINARIA NIT, SUMBUL BM Private Limited 3b3c955d-453e-28e2-e063-6394a90a6bf9 2026-02-15 Warnings Exact identifier ndc (product): 85816-2224
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85816-2224-1 85816222401 30 mL in 1 BOTTLE, GLASS (85816-2224-1) 30 ml 2015-01-01 No No Current 85816-2224-2 85816222402 500 mL in 1 BOTTLE, GLASS (85816-2224-2) 500 ml 2015-01-01 No No Current