FDA.reportPublic FDA data

Hypertension

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:53

Label at a glance#

ProductHypertension
Active ingredientMicrurus Corallinus Venom, Epinephrine, Arsenic Triiodide, Gold, Barium Carbonate, Bryonia Alba Root, Selenicereus Grandiflorus Stem, Chelidonium Majus, Cinchona Officinalis Bark, Crotalus Horridus Horridus Venom, Digitalis, Nitroglycerin, Potassium Carbonate, Potassium Iodide, Lachesis Muta Venom, Naja Naja Venom, Strychnos Nux-vomica Seed, Veratrum Album Root, Vipera Berus Venom, Viscum Album Fruiting Top, Ruta Graveolens Flowering Top, Valerian
Label structure10 sections

Label contents#

Full prescribing information#

PRODUCT NAME & INDICATIONS SECTION

INDICATIONS & USAGE SECTION

HYPERTENSION    Formulated for symptoms including headache, elevated B/P readings, tinnitus, anxiety, depression, sweating, pallor and nausea.                             

DIRECTION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally one to four times daily or as directed by a healthcare professional.   

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Elaps corallinus 30x, Adrenalinum 15x, Arsenicum iodatum 15x, Aur. met. 15x, Baryta carb. 15x, Bryonia 15x, Cactus 15x, Chelidonium majus 15x, Cinchona 15x, Crotalus horridus 15x, Digitalis 15x,  Glonoinum 15x, Kali carb. 15x, Kali iod. 15x, Lachesis  15x, Naja  15x, Nux vom. 15x, Veratrum alb. 15x, Vipera berus 15x, Viscum 15x, Ruta 3x, Valeriana 3x.      

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms including headache, elevated B/P readings, tinnitus, anxiety, depression, sweating, pallor and nausea.

INACTIVE INGREDIENT SECTION

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

QUESTIONS? SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256       

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.                  

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.          

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.               

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label
Package Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4424-12020-01-31C16284748780-19d75b9d0-c316-f424-e053-dadaa90a57ceHypertension
55714-4424-22020-01-31C16284748780-19d75b9d0-c316-f424-e053-dadaa90a57ceHypertension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4424-1Hypertension29.57 mL in 1 BOTTLE, GLASSLIQUID29.571
55714-4424-2Hypertension59.14 mL in 1 BOTTLE, GLASSLIQUID59.141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4424HYPERTENSION (ELAPS CORALLINUS, ADRENALINUM, ARSENICUM IODATUM , AUR. MET., BARYTA CARB., BRYONIA, CACTUS, CHELIDONIUM MAJUS, CINCHONA, CROTALUS HORRIDUS, DIGITALIS, GLONOINUM, KALI CARB., KALI IOD ., LACHESIS , NAJA , NUX VOM., VERATRUM ALB., VIPERA BERUS, VISCUM, RUTA, VALERIANA) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 2 package rows20120814_b1619473-c1b2-6e35-07c2-cc7ab77a18d7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Arsenic TriiodideACTIVE INGREDIENT3029988O2T1
Barium CarbonateACTIVE INGREDIENT6P669D8HQ81
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Chelidonium MajusACTIVE INGREDIENT7E889U5RNN1
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB1
Crotalus Horridus Horridus VenomACTIVE INGREDIENTYHA2XLJ9561
DigitalisACTIVE INGREDIENTF1T8QT9U8B1
EpinephrineACTIVE INGREDIENTYKH834O4BH1
GoldACTIVE INGREDIENT79Y1949PYO1
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I1
Micrurus Corallinus VenomACTIVE INGREDIENTV0S6H369801
Naja Naja VenomACTIVE INGREDIENTZZ4AG7L7VM1
NitroglycerinACTIVE INGREDIENTG59M7S0WS31
Potassium CarbonateACTIVE INGREDIENTBQN1B9B9HA1
Potassium IodideACTIVE INGREDIENT1C4QK22F9J1
Ruta Graveolens Flowering TopACTIVE INGREDIENTN94C2U587S1
Selenicereus Grandiflorus StemACTIVE INGREDIENT7114SV0MYK1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
ValerianACTIVE INGREDIENTJWF5YAW3QW1
Veratrum Album RootACTIVE INGREDIENTQNS6W5US1Z1
Vipera Berus VenomACTIVE INGREDIENT0ORO6NCA4M1
Viscum Album Fruiting TopACTIVE INGREDIENTBK9092J5MP1
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Barium CationACTIVE MOIETYV645272HLN1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Carbonate IonACTIVE MOIETY7UJQ5OPE7D1
Chelidonium MajusACTIVE MOIETY7E889U5RNN1
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB1
Crotalus Horridus Horridus VenomACTIVE MOIETYYHA2XLJ9561
DigitalisACTIVE MOIETYF1T8QT9U8B1
EpinephrineACTIVE MOIETYYKH834O4BH1
GoldACTIVE MOIETY79Y1949PYO1
Iodide IonACTIVE MOIETY09G4I6V86Q1
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I1
Micrurus Corallinus VenomACTIVE MOIETYV0S6H369801
Naja Naja VenomACTIVE MOIETYZZ4AG7L7VM1
NitroglycerinACTIVE MOIETYG59M7S0WS31
Ruta Graveolens Flowering TopACTIVE MOIETYN94C2U587S1
Selenicereus Grandiflorus StemACTIVE MOIETY7114SV0MYK1
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
ValerianACTIVE MOIETYJWF5YAW3QW1
Veratrum Album RootACTIVE MOIETYQNS6W5US1Z1
Vipera Berus VenomACTIVE MOIETY0ORO6NCA4M1
Viscum Album Fruiting TopACTIVE MOIETYBK9092J5MP1
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-442455714-4424-1, 55714-4424-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
Micrurus Corallinus VenomV0S6H36980ACTIB
EpinephrineYKH834O4BHACTIB
Arsenic Triiodide3029988O2TACTIB
Gold79Y1949PYOACTIB
Barium Carbonate6P669D8HQ8ACTIB
Bryonia Alba RootT7J046YI2BACTIB
Selenicereus Grandiflorus Stem7114SV0MYKACTIB
Chelidonium Majus7E889U5RNNACTIB
Cinchona Officinalis BarkS003A158SBACTIB
Crotalus Horridus Horridus VenomYHA2XLJ956ACTIB
DigitalisF1T8QT9U8BACTIB
NitroglycerinG59M7S0WS3ACTIB
Potassium CarbonateBQN1B9B9HAACTIB
Potassium Iodide1C4QK22F9JACTIB
Lachesis Muta VenomVSW71SS07IACTIB
Naja Naja VenomZZ4AG7L7VMACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Veratrum Album RootQNS6W5US1ZACTIB
Vipera Berus Venom0ORO6NCA4MACTIB
Viscum Album Fruiting TopBK9092J5MPACTIB
Ruta Graveolens Flowering TopN94C2U587SACTIB
ValerianJWF5YAW3QWACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates

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
f886f05e-a0ff-fbe4-8213-f31d1fd99f45b1619473-c1b2-6e35-07c2-cc7ab77a18d72011-06-01WarningsExact identifier
spl id: f886f05e-a0ff-fbe4-8213-f31d1fd99f45
spl set id: b1619473-c1b2-6e35-07c2-cc7ab77a18d7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.