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
- ARNICA MONTANA; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; FERULA SUMBUL ROOT; KALMIA LATIFOLIA LEAF; RANUNCULUS BULBOSUS ROOT; SANGUINARIA CANADENSIS ROOT
- Active strength
- 6; 7; 7; 10; 6; 10; 7 [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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KALMIA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ARNICA MONTANA | 6 [hp_X]/mL |
| CHELIDONIUM MAJUS | 7 [hp_X]/mL |
| COLCHICUM AUTUMNALE BULB | 7 [hp_X]/mL |
| FERULA SUMBUL ROOT | 10 [hp_X]/mL |
| KALMIA LATIFOLIA LEAF | 6 [hp_X]/mL |
| RANUNCULUS BULBOSUS ROOT | 10 [hp_X]/mL |
| SANGUINARIA CANADENSIS ROOT | 7 [hp_X]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O80TY208ZW, 7E889U5RNN, 993QHL78E6, GLA4808EHQ, 79N6542N18, XV11P9Y1A1, N9288CD508 |
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 |
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 | Historical |
| 85816-2224-2 | 85816222402 | 500 mL in 1 BOTTLE, GLASS (85816-2224-2) | 500 ml | 2015-01-01 | No | No | Historical |