CALMS FORTE
Calms Forte
Approved
Approval ID
63ce9942-a299-4d9b-b63b-35b297472dc9
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 9, 2025
Manufacturers
FDA
Hyland's Inc.
DUNS: 008316655
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54973-3257
Product Classification
G
Generic 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
Product Specifications
Route of AdministrationORAL
Effective DateApril 9, 2025
FDA Product Classification
INGREDIENTS (14)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STARCH, TAPIOCAInactive
Code: 24SC3U704I
Classification: IACT
MAGNESIUM PALMITOSTEARATEInactive
Code: R4OXA9G5BV
Classification: IACT
FERROSOFERRIC PHOSPHATEActive
Quantity: 3 [hp_X] in 1 1
Code: 91GQH8I5F7
Classification: ACTIB
POTASSIUM PHOSPHATE, DIBASICActive
Quantity: 3 [hp_X] in 1 1
Code: CI71S98N1Z
Classification: ACTIB
PASSIFLORA INCARNATA FLOWERActive
Quantity: 4 [hp_X] in 1 1
Code: K8F3G29S6Z
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEActive
Quantity: 3 [hp_X] in 1 1
Code: 70WT22SF4B
Classification: ACTIB
AVENA SATIVA FLOWERING TOPActive
Quantity: 4 [hp_X] in 1 1
Code: MA9CQJ3F7F
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MATRICARIA RECUTITAActive
Quantity: 4 [hp_X] in 1 1
Code: G0R4UBI2ZZ
Classification: ACTIB
HOPSActive
Quantity: 4 [hp_X] in 1 1
Code: 01G73H6H83
Classification: ACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEActive
Quantity: 3 [hp_X] in 1 1
Code: HF539G9L3Q
Classification: ACTIB
TRIBASIC CALCIUM PHOSPHATEActive
Quantity: 3 [hp_X] in 1 1
Code: 91D9GV0Z28
Classification: ACTIB