MedPath

StressCalm

StressCalm

Approved
Approval ID

af489aa8-9737-33e1-e053-2995a90ad280

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Mar 21, 2025

Manufacturers
FDA

Boiron

DUNS: 282560473

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ACONITUM NAPELLUS WHOLE, ATROPA BELLADONNA, CALENDULA OFFICINALIS FLOWERING TOP, CHELIDONIUM MAJUS WHOLE, ABRUS PRECATORIUS SEED, VIBURNUM OPULUS BARK

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0220-9333
Product Classification
G
Generic Name
ACONITUM NAPELLUS WHOLE, ATROPA BELLADONNA, CALENDULA OFFICINALIS FLOWERING TOP, CHELIDONIUM MAJUS WHOLE, ABRUS PRECATORIUS SEED, VIBURNUM OPULUS BARK
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2025
FDA Product Classification

INGREDIENTS (9)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
VIBURNUM OPULUS BARKActive
Quantity: 6 [hp_C] in 1 1
Code: T1UG6H6805
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
ACONITUM NAPELLUS WHOLEActive
Quantity: 6 [hp_C] in 1 1
Code: U0NQ8555JD
Classification: ACTIB
ATROPA BELLADONNAActive
Quantity: 6 [hp_C] in 1 1
Code: WQZ3G9PF0H
Classification: ACTIB
ABRUS PRECATORIUS SEEDActive
Quantity: 6 [hp_C] in 1 1
Code: 3OM8I6L7CD
Classification: ACTIB
CHELIDONIUM MAJUS WHOLEActive
Quantity: 6 [hp_C] in 1 1
Code: 7E889U5RNN
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CALENDULA OFFICINALIS FLOWERING TOPActive
Quantity: 6 [hp_C] in 1 1
Code: 18E7415PXQ
Classification: ACTIB

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StressCalm - FDA Drug Approval Details