MedPath

Panic Ease

Panic 4766L

Approved
Approval ID

9971a152-0706-8166-e053-2995a90aab9f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 23, 2025

Manufacturers
FDA

Newton Laboratories, Inc.

DUNS: 788793610

Products 1

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

Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus canadensis, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus spin., Rhus toxicodendron, Sarcolacticum ac., Sulphur, Veratrum alb., Valeriana.

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55714-4766
Product Classification
G
Generic Name
Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus canadensis, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus spin., Rhus toxicodendron, Sarcolacticum ac., Sulphur, Veratrum alb., Valeriana.
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2025
FDA Product Classification

INGREDIENTS (26)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ACONITUM NAPELLUSActive
Quantity: 15 [hp_X] in 1 mL
Code: U0NQ8555JD
Classification: ACTIB
APIS MELLIFERAActive
Quantity: 15 [hp_X] in 1 mL
Code: 7S82P3R43Z
Classification: ACTIB
ARNICA MONTANAActive
Quantity: 15 [hp_X] in 1 mL
Code: O80TY208ZW
Classification: ACTIB
ARSENIC TRIOXIDEActive
Quantity: 15 [hp_X] in 1 mL
Code: S7V92P67HO
Classification: ACTIB
ATROPA BELLADONNAActive
Quantity: 15 [hp_X] in 1 mL
Code: WQZ3G9PF0H
Classification: ACTIB
BELLIS PERENNISActive
Quantity: 15 [hp_X] in 1 mL
Code: 2HU33I03UY
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 15 [hp_X] in 1 mL
Code: T7J046YI2B
Classification: ACTIB
CALENDULA OFFICINALIS FLOWERING TOPActive
Quantity: 15 [hp_X] in 1 mL
Code: 18E7415PXQ
Classification: ACTIB
MATRICARIA CHAMOMILLAActive
Quantity: 15 [hp_X] in 1 mL
Code: G0R4UBI2ZZ
Classification: ACTIB
HELIANTHEMUM CANADENSEActive
Quantity: 15 [hp_X] in 1 mL
Code: 46G3W789Q3
Classification: ACTIB
FERROSOFERRIC PHOSPHATEActive
Quantity: 15 [hp_X] in 1 mL
Code: 91GQH8I5F7
Classification: ACTIB
HISTAMINE DIHYDROCHLORIDEActive
Quantity: 15 [hp_X] in 1 mL
Code: 3POA0Q644U
Classification: ACTIB
HYPERICUM PERFORATUMActive
Quantity: 15 [hp_X] in 1 mL
Code: XK4IUX8MNB
Classification: ACTIB
STRYCHNOS IGNATII SEEDActive
Quantity: 15 [hp_X] in 1 mL
Code: 1NM3M2487K
Classification: ACTIB
DAPHNE MEZEREUM BARKActive
Quantity: 15 [hp_X] in 1 mL
Code: X2N6E405GV
Classification: ACTIB
ORNITHOGALUM UMBELLATUMActive
Quantity: 15 [hp_X] in 1 mL
Code: 9NS3M2Y78S
Classification: ACTIB
PASSIFLORA INCARNATA FLOWERING TOPActive
Quantity: 15 [hp_X] in 1 mL
Code: CLF5YFS11O
Classification: ACTIB
PHOSPHORUSActive
Quantity: 15 [hp_X] in 1 mL
Code: 27YLU75U4W
Classification: ACTIB
PRUNUS SPINOSA FLOWER BUDActive
Quantity: 15 [hp_X] in 1 mL
Code: 53Y84VPS2W
Classification: ACTIB
TOXICODENDRON PUBESCENS LEAFActive
Quantity: 15 [hp_X] in 1 mL
Code: 6IO182RP7A
Classification: ACTIB
LACTIC ACID, L-Active
Quantity: 15 [hp_X] in 1 mL
Code: F9S9FFU82N
Classification: ACTIB
SULFURActive
Quantity: 15 [hp_X] in 1 mL
Code: 70FD1KFU70
Classification: ACTIB
VERATRUM ALBUM ROOTActive
Quantity: 15 [hp_X] in 1 mL
Code: QNS6W5US1Z
Classification: ACTIB
VALERIANActive
Quantity: 6 [hp_X] in 1 mL
Code: JWF5YAW3QW
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/2/2019

PACKAGE LABEL

package label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/23/2025

INDICATIONS & USAGE SECTION

Formulated for symptoms such as fellings of panic, anxiety, tension or fear.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/2/2019

DOSAGE & ADMINISTRATION SECTION

**Directions:**Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/2/2019

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 6x, Valeriana 6x, Aconitum nap. 15x, Apis mel. 15x, Arnica 15x, Arsenicum alb. 15x, Belladonna 15x, Bellis 15x, Bryonia 15x, Calendula 15x, Chamomilla 15x, Cistus canadensis 15x, Ferrum phosphoricum 15x, Histaminum hydrochloricum 15x, Hypericum 15x, Ignatia 15x, Mezereum 15x, Ornithogalum 15x, Passiflora 15x, Phosphorus 15x, Prunus spin. 15x, Rhus toxicodendron 15x, Sarcolacticum ac. 15x, Sulphur 15x, Veratrum alb. 15x.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/23/2025

OTC - PURPOSE SECTION

Formulated for symptoms such as fellings of panic, anxiety, tension or fear.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/2/2019

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/2/2019

QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

LOINC: 34071-1Updated: 9/2/2019

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. Ifpregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 9/2/2019

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ifpregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/2/2019

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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Panic Ease - FDA Drug Approval Details