Hypercalm-Mental Focus

Product NDC
55714-1738
11-digit product format
557141738
Labeler code
55714
Product ID
55714-1738_ff60427d-49e3-b5f4-e053-6294a90ad12c
Type
HUMAN OTC DRUG
Nonproprietary name
Chamomilla, Echinacea, Hypericum perforatum, Passiflora incarnata, Aconitum napellus, Adrenalinum, Argentum nit., Arsenicum album, Baptisia tinctoria, Chamomilla, Coffea cruda, Cypripedium pubescens, Digitalis purpurea, Gelsemium sempervirens, Humulus lupulus, Hyoscyamus niger, Ignatia amara, Impatiens glandulifera flos, Iodium, Lachesis mutus, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Scutellaria lateriflora, Staphysagria, Stramonium, Theridion, Veratrum viride
Dosage form
PELLET
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-06-01
Substance
ACONITUM NAPELLUS; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GELSEMIUM SEMPERVIRENS ROOT; HOPS; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MATRICARIA CHAMOMILLA; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA WHOLE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; VERATRUM VIRIDE ROOT
Active strength
15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hypercalm-Mental Focus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS15 [hp_X]/g
ARABICA COFFEE BEAN15 [hp_X]/g
ARSENIC TRIOXIDE15 [hp_X]/g
BAPTISIA TINCTORIA ROOT15 [hp_X]/g
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT15 [hp_X]/g
DATURA STRAMONIUM15 [hp_X]/g
DELPHINIUM STAPHISAGRIA SEED15 [hp_X]/g
DIGITALIS15 [hp_X]/g
ECHINACEA, UNSPECIFIED6 [hp_X]/g
EPINEPHRINE15 [hp_X]/g
GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]/g
HOPS15 [hp_X]/g
HYOSCYAMUS NIGER15 [hp_X]/g
HYPERICUM PERFORATUM6 [hp_X]/g
IMPATIENS GLANDULIFERA FLOWER15 [hp_X]/g
IODINE15 [hp_X]/g
LACHESIS MUTA VENOM15 [hp_X]/g
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/g
MATRICARIA CHAMOMILLA15 [hp_X]/g
PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]/g
SCUTELLARIA LATERIFLORA WHOLE15 [hp_X]/g
SILVER NITRATE15 [hp_X]/g
SODIUM CHLORIDE15 [hp_X]/g
STRYCHNOS IGNATII SEED15 [hp_X]/g
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/g
THERIDION CURASSAVICUM15 [hp_X]/g
VERATRUM VIRIDE ROOT15 [hp_X]/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, 3SW678MX72, S7V92P67HO, 5EF0HWI5WU, 21Y9GZ1LZA, G6W4F0V8Z3, 00543AP1JV, F1T8QT9U8B, 4N9P6CC1DX, YKH834O4BH, 639KR60Q1Q, 01G73H6H83, 4WRK2153H3, XK4IUX8MNB, AJU5O1A5ZV, 9679TC07X4, VSW71SS07I, C88X29Y479, G0R4UBI2ZZ, CLF5YFS11O

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-1738-1Hypercalm-Mental Focus28 g in 1 BOTTLE, GLASSPELLET281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1738HYPERCALM-MENTAL FOCUS (CHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDE) PELLET [NEWTON LABORATORIES, INC.]1Current NDC, 1 package rows20230702_ff604442-4697-e2bb-e053-6394a90a0340.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55714-1738-15571417380128 g in 1 BOTTLE, GLASS (55714-1738-1) 28 g2023-06-01NoNoCurrent