FDA.reportPublic FDA data

Hemorrhoids

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#

ProductHemorrhoids
Active ingredientMicrurus Corallinus Venom, Horse Chestnut, Aloe, Arsenic Trioxide, Bryonia Alba Root, Calcium Fluoride, Capsicum, Collinsonia Canadensis Root, Crotalus Horridus Horridus Venom, Hamamelis Virginiana Root Bark/stem Bark, Hydrofluoric Acid, Hypericum Perforatum, Lachesis Muta Venom, Lycopodium Clavatum Spore, Achillea Millefolium, Naja Naja Venom, Strychnos Nux-vomica Seed, Paeonia Officinalis Root, Plantago Major, Quercus Robur Nut, Krameria Lappacea Root, Vipera Berus Venom, Echinacea, Unspecified, Solidago Virgaurea Flowering Top, Urtica Urens
Label structure10 sections

Label contents#

Full prescribing information#

PRODUCT NAME & INDICATIONS SECTION

INDICATIONS & USAGE SECTION

HEMORRHOIDS  Formulated for associated symptoms such as enlarged or bleeding hemorrhoidal veins, itching, inflammation, burning pain and pressure.     

DIRECTION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional.     

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Elaps corallinus 35x, Aesculus hipp. 20x, Aloe 20x, Arsenicum alb. 20x, Bryonia 20x, Calc. fluor. 20x, Capsicum 20x, Collinsonia 20x, Crotalus horridus 20x, Hamamelis 20x, Hydrofluoricum acidum 20x, Hypericum 20x, Lachesis 20x, Lycopodium 20x, Millefolium 20x, Naja 20x, Nux vom. 20x, Paeonia 20x, Plantago 20x, Quercus glandium spiritus 20x, Ratanhia 20x, Vipera berus 20x, Aesculus hipp 8x, Echinacea 8x, Solidago 8x, Urtica ur. 8x, Aesculus hipp. 3x, Echinacea 3x, Solidago 3x, Urtica ur. 3x.         

PURPOSE SECTION

ABUSE SECTION

Formulated for associated symptoms such as enlarged or bleeding hemorrhoidal veins, itching, inflammation, burning pain and pressure.

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

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
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4446-12020-01-31C16284748780-19d75b9cf-e822-f424-e053-dadaa90a57ceHemorrhoids
55714-4446-22020-01-31C16284748780-19d75b9cf-e822-f424-e053-dadaa90a57ceHemorrhoids

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4446-1Hemorrhoids29.57 mL in 1 BOTTLE, GLASSLIQUID29.571
55714-4446-2Hemorrhoids59.14 mL in 1 BOTTLE, GLASSLIQUID59.141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4446HEMORRHOIDS (ELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, AESCULUS HIPP, ECHINACEA, SOLIDAGO, URTICA UR., AESCULUS HIPP., ECHINACEA, SOLIDAGO, URTICA UR.) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 2 package rows20120814_e4c9240d-46fe-6586-bedc-f74d070ec2d4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Achillea MillefoliumACTIVE INGREDIENT2FXJ6SW4PK1
AloeACTIVE INGREDIENTV5VD430YW91
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Calcium FluorideACTIVE INGREDIENTO3B55K4YKI1
CapsicumACTIVE INGREDIENT00UK7646FG1
Collinsonia Canadensis RootACTIVE INGREDIENTO2630F3XDR1
Crotalus Horridus Horridus VenomACTIVE INGREDIENTYHA2XLJ9561
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
Hamamelis Virginiana Root Bark/stem BarkACTIVE INGREDIENTT7S323PKJS1
Horse ChestnutACTIVE INGREDIENT3C18L6RJAZ1
Hydrofluoric AcidACTIVE INGREDIENTRGL5YE86CZ1
Hypericum PerforatumACTIVE INGREDIENTXK4IUX8MNB1
Krameria Lappacea RootACTIVE INGREDIENTP29ZH1A35Z1
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
Micrurus Corallinus VenomACTIVE INGREDIENTV0S6H369801
Naja Naja VenomACTIVE INGREDIENTZZ4AG7L7VM1
Paeonia Officinalis RootACTIVE INGREDIENT8R564U2E1P1
Plantago MajorACTIVE INGREDIENTW2469WNO6U1
Quercus Robur NutACTIVE INGREDIENTQ7MU1F4GLY1
Solidago Virgaurea Flowering TopACTIVE INGREDIENT5405K23S501
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Urtica UrensACTIVE INGREDIENTIHN2NQ5OF91
Vipera Berus VenomACTIVE INGREDIENT0ORO6NCA4M1
Achillea MillefoliumACTIVE MOIETY2FXJ6SW4PK1
AloeACTIVE MOIETYV5VD430YW91
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
CapsicumACTIVE MOIETY00UK7646FG1
Collinsonia Canadensis RootACTIVE MOIETYO2630F3XDR1
Crotalus Horridus Horridus VenomACTIVE MOIETYYHA2XLJ9561
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
Fluoride IonACTIVE MOIETYQ80VPU408O1
Hamamelis Virginiana Root Bark/stem BarkACTIVE MOIETYT7S323PKJS1
Horse ChestnutACTIVE MOIETY3C18L6RJAZ1
Hydrofluoric AcidACTIVE MOIETYRGL5YE86CZ1
Hypericum PerforatumACTIVE MOIETYXK4IUX8MNB1
Krameria Lappacea RootACTIVE MOIETYP29ZH1A35Z1
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
Micrurus Corallinus VenomACTIVE MOIETYV0S6H369801
Naja Naja VenomACTIVE MOIETYZZ4AG7L7VM1
Paeonia Officinalis RootACTIVE MOIETY8R564U2E1P1
Plantago MajorACTIVE MOIETYW2469WNO6U1
Quercus Robur NutACTIVE MOIETYQ7MU1F4GLY1
Solidago Virgaurea Flowering TopACTIVE MOIETY5405K23S501
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Urtica UrensACTIVE MOIETYIHN2NQ5OF91
Vipera Berus VenomACTIVE MOIETY0ORO6NCA4M1
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-444655714-4446-1, 55714-4446-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
Micrurus Corallinus VenomV0S6H36980ACTIB
Horse Chestnut3C18L6RJAZACTIB
AloeV5VD430YW9ACTIB
Arsenic TrioxideS7V92P67HOACTIB
Bryonia Alba RootT7J046YI2BACTIB
Calcium FluorideO3B55K4YKIACTIB
Capsicum00UK7646FGACTIB
Collinsonia Canadensis RootO2630F3XDRACTIB
Crotalus Horridus Horridus VenomYHA2XLJ956ACTIB
Hamamelis Virginiana Root Bark/stem BarkT7S323PKJSACTIB
Hydrofluoric AcidRGL5YE86CZACTIB
Hypericum PerforatumXK4IUX8MNBACTIB
Lachesis Muta VenomVSW71SS07IACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Achillea Millefolium2FXJ6SW4PKACTIB
Naja Naja VenomZZ4AG7L7VMACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Paeonia Officinalis Root8R564U2E1PACTIB
Plantago MajorW2469WNO6UACTIB
Quercus Robur NutQ7MU1F4GLYACTIB
Krameria Lappacea RootP29ZH1A35ZACTIB
Vipera Berus Venom0ORO6NCA4MACTIB
Horse Chestnut3C18L6RJAZACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Solidago Virgaurea Flowering Top5405K23S50ACTIB
Urtica UrensIHN2NQ5OF9ACTIB
Horse Chestnut3C18L6RJAZACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Solidago Virgaurea Flowering Top5405K23S50ACTIB
Urtica UrensIHN2NQ5OF9ACTIB
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
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact 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
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
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 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
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact 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
8a1a289b-e2ec-31aa-3039-d9b8967c6660e4c9240d-46fe-6586-bedc-f74d070ec2d42011-06-01WarningsExact identifier
spl id: 8a1a289b-e2ec-31aa-3039-d9b8967c6660
spl set id: e4c9240d-46fe-6586-bedc-f74d070ec2d4

Reported adverse events (FAERS/openFDA)#

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