Home NDC 54973-3257 CALMS FORTE
Product NDC 54973-3257
11-digit product format 549733257
Labeler code 54973
Product ID 54973-3257_325df1b7-48f6-0c03-e063-6294a90ad844
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 TRIBASIC CALCIUM PHOSPHATE 3 [hp_X]/1 MATRICARIA RECUTITA 4 [hp_X]/1 FERROSOFERRIC PHOSPHATE 3 [hp_X]/1 HOPS 4 [hp_X]/1 POTASSIUM PHOSPHATE, DIBASIC 4 [hp_X]/1 MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 3 [hp_X]/1 SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 3 [hp_X]/1 PASSIFLORA INCARNATA FLOWER 3 [hp_X]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 9 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54973-3257 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.] 10 Current NDC, Legacy NDC, 6 package rows 20250410_63ce9942-a299-4d9b-b63b-35b297472dc9.zip
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 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 Hyland's Inc. 63ce9942-a299-4d9b-b63b-35b297472dc9 2025-04-09 Warnings Exact identifier ndc (product): 54973-3257
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54973-3257-1 54973325701 1 BOTTLE, PLASTIC in 1 CARTON (54973-3257-1) / 50 TABLET in 1 BOTTLE, PLASTIC 2016-04-29 0000-00-00 No No Current 54973-3257-2 54973325702 100 TABLET in 1 BOTTLE, PLASTIC (54973-3257-2) 100 tablet 2016-04-29 0000-00-00 No No Current 54973-3257-3 54973325703 4 TABLET in 1 BOTTLE, PLASTIC (54973-3257-3) 4 tablet 2016-04-29 0000-00-00 No No Current 54973-3257-7 54973325707 1 BOTTLE, PLASTIC in 1 CARTON (54973-3257-7) / 100 TABLET in 1 BOTTLE, PLASTIC 2016-04-29 0000-00-00 No No Current