Hypercalm-Mental Focus
- Product NDC
- 55714-1538
- 11-digit product format
- 557141538
- Labeler code
- 55714
- Product ID
- 55714-1538_ff5f3962-3ef4-fddb-e053-6394a90afc33
- 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
- LIQUID
- 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]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
- 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
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 55714-1538-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 55714-1538-1 | 0efc9e666f02… | f202fb6c5f17… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hypercalm-Mental Focus
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ECHINACEA, UNSPECIFIED | 15 [hp_X]/mL |
| GELSEMIUM SEMPERVIRENS ROOT | 15 [hp_X]/mL |
| PASSIFLORA INCARNATA FLOWERING TOP | 15 [hp_X]/mL |
| ACONITUM NAPELLUS | 15 [hp_X]/mL |
| EPINEPHRINE | 15 [hp_X]/mL |
| SILVER NITRATE | 15 [hp_X]/mL |
| ARSENIC TRIOXIDE | 15 [hp_X]/mL |
| BAPTISIA TINCTORIA ROOT | 15 [hp_X]/mL |
| MATRICARIA CHAMOMILLA | 6 [hp_X]/mL |
| ARABICA COFFEE BEAN | 15 [hp_X]/mL |
| CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT | 15 [hp_X]/mL |
| DIGITALIS | 15 [hp_X]/mL |
| HYOSCYAMUS NIGER | 15 [hp_X]/mL |
| STRYCHNOS IGNATII SEED | 6 [hp_X]/mL |
| IMPATIENS GLANDULIFERA FLOWER | 15 [hp_X]/mL |
| IODINE | 15 [hp_X]/mL |
| LACHESIS MUTA VENOM | 15 [hp_X]/mL |
| LYCOPODIUM CLAVATUM SPORE | 15 [hp_X]/mL |
| SODIUM CHLORIDE | 15 [hp_X]/mL |
| STRYCHNOS NUX-VOMICA SEED | 6 [hp_X]/mL |
| SCUTELLARIA LATERIFLORA WHOLE | 15 [hp_X]/mL |
| DELPHINIUM STAPHISAGRIA SEED | 15 [hp_X]/mL |
| DATURA STRAMONIUM | 15 [hp_X]/mL |
| THERIDION CURASSAVICUM | 15 [hp_X]/mL |
| VERATRUM VIRIDE ROOT | 15 [hp_X]/mL |
| HOPS | 15 [hp_X]/mL |
| HYPERICUM PERFORATUM | 15 [hp_X]/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4N9P6CC1DX | Internal UNII lookup |
| 639KR60Q1Q | Internal UNII lookup |
| CLF5YFS11O | Internal UNII lookup |
| U0NQ8555JD | Internal UNII lookup |
| YKH834O4BH | Internal UNII lookup |
| 95IT3W8JZE | Internal UNII lookup |
| S7V92P67HO | Internal UNII lookup |
| 5EF0HWI5WU | Internal UNII lookup |
| G0R4UBI2ZZ | Internal UNII lookup |
| 3SW678MX72 | Internal UNII lookup |
| 21Y9GZ1LZA | Internal UNII lookup |
| F1T8QT9U8B | Internal UNII lookup |
| 4WRK2153H3 | Internal UNII lookup |
| 1NM3M2487K | Internal UNII lookup |
| AJU5O1A5ZV | Internal UNII lookup |
| 9679TC07X4 | Internal UNII lookup |
| VSW71SS07I | Internal UNII lookup |
| C88X29Y479 | Internal UNII lookup |
| 451W47IQ8X | Internal UNII lookup |
| 269XH13919 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ff5f22e1-74ee-1eee-e053-6394a90a2678 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-1538-1 | Hypercalm-Mental Focus | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-1538 | HYPERCALM-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) LIQUID [NEWTON LABORATORIES, INC.] | 1 | Current NDC, 1 package rows | 20230702_ff5f22e1-74ee-1eee-e053-6394a90a2678.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hypercalm-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 | Newton Laboratories, Inc. | ff5f22e1-74ee-1eee-e053-6394a90a2678 | 2023-06-30 | Warnings | 55714-1538 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55714-1538-1 | 55714153801 | 30 mL in 1 BOTTLE, GLASS (55714-1538-1) | 30 ml | 2023-06-01 | No | No | Current |