CALMS FORTE
- Product NDC
- 54973-3274
- 11-digit product format
- 549733274
- Labeler code
- 54973
- Product ID
- 54973-3274_ef42fef9-4849-0874-e053-2a95a90a4e80
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hyland's Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2016-04-29
- Substance
- AVENA SATIVA FLOWERING TOP; FERROSOFERRIC PHOSPHATE; HOPS; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWER; POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TRIBASIC CALCIUM PHOSPHATE
- Active strength
- 4; 3; 4; 3; 4; 4; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
- Pharmacologic classes
- Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CALMS FORTE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVENA SATIVA FLOWERING TOP | 4 [hp_X]/1 |
| FERROSOFERRIC PHOSPHATE | 3 [hp_X]/1 |
| HOPS | 4 [hp_X]/1 |
| MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE | 3 [hp_X]/1 |
| MATRICARIA RECUTITA | 4 [hp_X]/1 |
| PASSIFLORA INCARNATA FLOWER | 4 [hp_X]/1 |
| POTASSIUM PHOSPHATE, DIBASIC | 3 [hp_X]/1 |
| SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | 3 [hp_X]/1 |
| TRIBASIC CALCIUM PHOSPHATE | 3 [hp_X]/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MA9CQJ3F7F, 91GQH8I5F7, 01G73H6H83, HF539G9L3Q, G0R4UBI2ZZ, K8F3G29S6Z, CI71S98N1Z, 70WT22SF4B, 91D9GV0Z28 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54973-3274-1 | CALMS FORTE | 1 in 1 CARTON | TABLET | 1 | | 3 |
| 54973-3274-1 | CALMS FORTE | 32 in 1 BOTTLE, PLASTIC | TABLET | 32 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54973-3274 | CALMS FORTE (AVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND PASSIFLORA INCARNATA FLOWER) TABLET [HYLAND'S INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20221208_f48a35d4-aa0c-48b1-a2ad-a614ea2894e8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54973-3274-1 | 54973327401 | 1 BOTTLE, PLASTIC in 1 CARTON (54973-3274-1) / 32 TABLET in 1 BOTTLE, PLASTIC | 2016-04-29 | 0000-00-00 | No | No | Current |