Home NDC 54973-3274 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 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# 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
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. f48a35d4-aa0c-48b1-a2ad-a614ea2894e8 2022-12-07 Warnings Exact identifier ndc (product): 54973-3274
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