Hemorrhoids

Manufacturer: Newton Laboratories, Inc.
Effective date: 2011-03-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:05:19

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

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Hemorrhoids Formulated for symptoms associated with hemorrhoids such as difficult elimination, itching, inflammation, burning pain and pressure.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Elaps corallinus 30x, Aesculus hipp.15x, Aloe 15x, Arsenicum alb. 15x, Bryonia 15x, Calc. fluor. 15x, Capsicum 15x, Collinsonia 15x, Crotalus horridus 15x, Hamamelis 15x, Hydrofluoricum acidum 15x, Hypericum 15x, Lachesis 15x, Lycopodium 15x, Millefolium 15x, Naja 15x, Nux vom. 15x, Paeonia 15x, Plantago 15x, Quercus glandium spiritus 15x, Ratanhia 15x, Vipera berus 15x, Aesculus hipp. 3x, Echinacea 3x, Solidago 3x, Urtica ur. 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with hemorrhoids such as difficult elimination, itching, inflammation, burning pain and pressure.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

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, 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-2221-0	2020-01-31	C162847	48780-1	9d75b9d1-07d1-f424-e053-dadaa90a57ce	Hemorrhoids
55714-2221-1	2020-01-31	C162847	48780-1	9d75b9d1-07d1-f424-e053-dadaa90a57ce	Hemorrhoids
55714-2221-2	2020-01-31	C162847	48780-1	9d75b9d1-07d1-f424-e053-dadaa90a57ce	Hemorrhoids

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55714-2221-0	Hemorrhoids	7.08 g in 1 BOTTLE, GLASS	PELLET	7.08	1
55714-2221-1	Hemorrhoids	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35	1
55714-2221-2	Hemorrhoids	56.7 g in 1 BOTTLE, GLASS	PELLET	56.7	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-2221	HEMORRHOIDS (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, ECHINACEA, SOLIDAGO, URTICA UR.) PELLET [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 3 package rows	20131218_df2ca7f9-dd86-e90d-5ff2-44b1c1e8ba81.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Achillea Millefolium	ACTIVE INGREDIENT	2FXJ6SW4PK	1
Aloe	ACTIVE INGREDIENT	V5VD430YW9	1
Arsenic Trioxide	ACTIVE INGREDIENT	S7V92P67HO	1
Bryonia Alba Root	ACTIVE INGREDIENT	T7J046YI2B	1
Calcium Fluoride	ACTIVE INGREDIENT	O3B55K4YKI	1
Capsicum	ACTIVE INGREDIENT	00UK7646FG	1
Collinsonia Canadensis Root	ACTIVE INGREDIENT	O2630F3XDR	1
Crotalus Horridus Horridus Venom	ACTIVE INGREDIENT	YHA2XLJ956	1
Echinacea, Unspecified	ACTIVE INGREDIENT	4N9P6CC1DX	1
Hamamelis Virginiana Root Bark/stem Bark	ACTIVE INGREDIENT	T7S323PKJS	1
Horse Chestnut	ACTIVE INGREDIENT	3C18L6RJAZ	1
Hydrofluoric Acid	ACTIVE INGREDIENT	RGL5YE86CZ	1
Hypericum Perforatum	ACTIVE INGREDIENT	XK4IUX8MNB	1
Krameria Lappacea Root	ACTIVE INGREDIENT	P29ZH1A35Z	1
Lachesis Muta Venom	ACTIVE INGREDIENT	VSW71SS07I	1
Lycopodium Clavatum Spore	ACTIVE INGREDIENT	C88X29Y479	1
Micrurus Corallinus Venom	ACTIVE INGREDIENT	V0S6H36980	1
Naja Naja Venom	ACTIVE INGREDIENT	ZZ4AG7L7VM	1
Paeonia Officinalis Root	ACTIVE INGREDIENT	8R564U2E1P	1
Plantago Major	ACTIVE INGREDIENT	W2469WNO6U	1
Quercus Robur Nut	ACTIVE INGREDIENT	Q7MU1F4GLY	1
Solidago Virgaurea Flowering Top	ACTIVE INGREDIENT	5405K23S50	1
Strychnos Nux-vomica Seed	ACTIVE INGREDIENT	269XH13919	1
Urtica Urens	ACTIVE INGREDIENT	IHN2NQ5OF9	1
Vipera Berus Venom	ACTIVE INGREDIENT	0ORO6NCA4M	1
Achillea Millefolium	ACTIVE MOIETY	2FXJ6SW4PK	1
Aloe	ACTIVE MOIETY	V5VD430YW9	1
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	1
Bryonia Alba Root	ACTIVE MOIETY	T7J046YI2B	1
Capsicum	ACTIVE MOIETY	00UK7646FG	1
Collinsonia Canadensis Root	ACTIVE MOIETY	O2630F3XDR	1
Crotalus Horridus Horridus Venom	ACTIVE MOIETY	YHA2XLJ956	1
Echinacea, Unspecified	ACTIVE MOIETY	4N9P6CC1DX	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	1
Hamamelis Virginiana Root Bark/stem Bark	ACTIVE MOIETY	T7S323PKJS	1
Horse Chestnut	ACTIVE MOIETY	3C18L6RJAZ	1
Hypericum Perforatum	ACTIVE MOIETY	XK4IUX8MNB	1
Krameria Lappacea Root	ACTIVE MOIETY	P29ZH1A35Z	1
Lachesis Muta Venom	ACTIVE MOIETY	VSW71SS07I	1
Lycopodium Clavatum Spore	ACTIVE MOIETY	C88X29Y479	1
Micrurus Corallinus Venom	ACTIVE MOIETY	V0S6H36980	1
Naja Naja Venom	ACTIVE MOIETY	ZZ4AG7L7VM	1
Paeonia Officinalis Root	ACTIVE MOIETY	8R564U2E1P	1
Plantago Major	ACTIVE MOIETY	W2469WNO6U	1
Quercus Robur Nut	ACTIVE MOIETY	Q7MU1F4GLY	1
Solidago Virgaurea Flowering Top	ACTIVE MOIETY	5405K23S50	1
Strychnos Nux-vomica Seed	ACTIVE MOIETY	269XH13919	1
Urtica Urens	ACTIVE MOIETY	IHN2NQ5OF9	1
Vipera Berus Venom	ACTIVE MOIETY	0ORO6NCA4M	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

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

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

Hemorrhoids
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, Echinacea, Solidago, Urtica ur.
Micrurus Corallinus Venom
Horse Chestnut
Aloe
Arsenic Trioxide
Arsenic Cation (3+)
Bryonia Alba Root
Calcium Fluoride
Fluoride Ion
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
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-2221	55714-2221-1, 55714-2221-2, 55714-2221-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Micrurus Corallinus Venom	V0S6H36980	ACTIB
Horse Chestnut	3C18L6RJAZ	ACTIB
Aloe	V5VD430YW9	ACTIB
Arsenic Trioxide	S7V92P67HO	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Calcium Fluoride	O3B55K4YKI	ACTIB
Capsicum	00UK7646FG	ACTIB
Collinsonia Canadensis Root	O2630F3XDR	ACTIB
Crotalus Horridus Horridus Venom	YHA2XLJ956	ACTIB
Hamamelis Virginiana Root Bark/stem Bark	T7S323PKJS	ACTIB
Hydrofluoric Acid	RGL5YE86CZ	ACTIM
Hypericum Perforatum	XK4IUX8MNB	ACTIB
Lachesis Muta Venom	VSW71SS07I	ACTIB
Lycopodium Clavatum Spore	C88X29Y479	ACTIB
Achillea Millefolium	2FXJ6SW4PK	ACTIB
Naja Naja Venom	ZZ4AG7L7VM	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Paeonia Officinalis Root	8R564U2E1P	ACTIB
Plantago Major	W2469WNO6U	ACTIB
Quercus Robur Nut	Q7MU1F4GLY	ACTIB
Krameria Lappacea Root	P29ZH1A35Z	ACTIB
Vipera Berus Venom	0ORO6NCA4M	ACTIB
Echinacea, Unspecified	4N9P6CC1DX	ACTIB
Solidago Virgaurea Flowering Top	5405K23S50	ACTIB
Urtica Urens	IHN2NQ5OF9	ACTIB
Sucrose	C151H8M554	IACT

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 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
84365aa1-1068-c019-b6cb-e2688e8b2594			df2ca7f9-dd86-e90d-5ff2-44b1c1e8ba81	2011-03-01	Warnings	Exact identifier spl id: 84365aa1-1068-c019-b6cb-e2688e8b2594 spl set id: df2ca7f9-dd86-e90d-5ff2-44b1c1e8ba81

Reported adverse events (FAERS/openFDA)#

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