FDA.reportPublic FDA data

Hyperactivity-Mental Focus

Product NDC
55714-2579
Requested package NDC
55714-2579-1
11-digit product format
557142579
Labeler code
55714
Product ID
55714-2579_febf5942-5eca-f19b-e053-6294a90a32c1
Type
HUMAN OTC DRUG
Nonproprietary name
Adrenalinum, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Chamomilla, Cypripedium, Digitalis, Gelsemium, Humulus, Ignatia, Impatiens glandulifera flos, Iodium, Lachesis, Lycopodium, Nat. mur., Nux vom., Scutellaria lateriflora, Staphysag., Stramonium, Theridion, Echinacea, Gingko, Hypericum, Passiflora
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-07-03
Substance
ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; HOPS; 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
Active strength
15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 6; 15; 6; 15; 15; 15; 15; 15; 6; 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
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant 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.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-257955714-2579-1UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-257955714-2579-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SCUTELLARIA LATERIFLORA WHOLE15 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED15 [hp_X]/mL
DATURA STRAMONIUM15 [hp_X]/mL
THERIDION CURASSAVICUM15 [hp_X]/mL
ECHINACEA, UNSPECIFIED15 [hp_X]/mL
GINKGO15 [hp_X]/mL
HYPERICUM PERFORATUM15 [hp_X]/mL
PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]/mL
EPINEPHRINE15 [hp_X]/mL
ACONITUM NAPELLUS15 [hp_X]/mL
SILVER NITRATE6 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
BAPTISIA TINCTORIA ROOT6 [hp_X]/mL
MATRICARIA CHAMOMILLA15 [hp_X]/mL
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT15 [hp_X]/mL
DIGITALIS15 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]/mL
HOPS15 [hp_X]/mL
STRYCHNOS IGNATII SEED6 [hp_X]/mL
IMPATIENS GLANDULIFERA FLOWER15 [hp_X]/mL
IODINE15 [hp_X]/mL
LACHESIS MUTA VENOM15 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/mL
SODIUM CHLORIDE15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 25 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7BP4DH5PDCInternal UNII lookup
00543AP1JVInternal UNII lookup
G6W4F0V8Z3Internal UNII lookup
9Z8D3HEM8LInternal UNII lookup
4N9P6CC1DXInternal UNII lookup
19FUJ2C58TInternal UNII lookup
XK4IUX8MNBInternal UNII lookup
CLF5YFS11OInternal UNII lookup
YKH834O4BHInternal UNII lookup
U0NQ8555JDInternal UNII lookup
95IT3W8JZEInternal UNII lookup
S7V92P67HOInternal UNII lookup
5EF0HWI5WUInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
21Y9GZ1LZAInternal UNII lookup
F1T8QT9U8BInternal UNII lookup
639KR60Q1QInternal UNII lookup
01G73H6H83Internal UNII lookup
1NM3M2487KInternal UNII lookup
AJU5O1A5ZVInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
febf610e-e08a-4797-e053-6294a90a3eb5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2579-1Hyperactivity-Mental Focus30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2579HYPERACTIVITY-MENTAL FOCUS (ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA) LIQUID [NEWTON LABORATORIES, INC.]1Current NDC, 1 package rows20230703_febf610e-e08a-4797-e053-6294a90a3eb5.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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.febf610e-e08a-4797-e053-6294a90a3eb52023-06-22WarningsExact identifier
ndc (package): 55714-2579-1
ndc (product): 55714-2579
ndc11 (package): 55714257901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55714-2579-15571425790130 mL in 1 BOTTLE, GLASS (55714-2579-1) 30 ml2023-07-03NoNoCurrent