Urticaria - Rashes

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 02:05:10

Label at a glance#

ProductUrticaria - Rashes

Active ingredientAntimony Trisulfide, Apis Mellifera, Arsenic Trioxide, Berberis Vulgaris Root Bark, Giant Puffball, Bryonia Alba Root, Lytta Vesicatoria, Chelidonium Majus, Croton Tiglium Seed, Solanum Dulcamara Top, Graphite, Histamine Dihydrochloride, Lycopodium Clavatum Spore, Daphne Mezereum Bark, Strychnos Nux-vomica Seed, Kerosene, Pulex Irritans, Pulsatilla Vulgaris, Toxicodendron Pubescens Leaf, Smilax Regelii Root, Sulfur, Echinacea, Unspecified, Rumex Crispus Root, Taraxacum Officinale, 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

Urticaria - Rashes Formulated for symptoms associated with hives and other allergic skin responses such as burning, itching, redness, swelling and discomfort.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Antimon. crud. 15x, Apis mel. 15x, Arsenicum alb. 15x, Berber. vulg. 15x, Bovista 15x, Bryonia 15x, Cantharis 15x, Chelidonium majus 15x, Croton 15x, Dulcamara 15x, Graphites 15x, Histaminum hydrochloricum 15x, Lycopodium 15x, Mezereum 15x, Nux vom. 15x, Petroleum 15x, Pulex irritans 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Sarsaparilla 15x, Sulphur 15x, Echinacea 3x, Rumex crisp. 3x, Taraxacum 3x, Urtica ur.3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms associated with hives and other allergic skin responses such as burning, itching, redness, swelling and discomfort.

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.

PREGNANCY OR BREAST FEEDING SECTION

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.

KEEP OUT OF REACH OF CHILDREN SECTION

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
55714-4529-1	2020-01-31	C162847	48780-1	9d75b9d0-ff46-f424-e053-dadaa90a57ce	Urticaria - Rashes
55714-4529-2	2020-01-31	C162847	48780-1	9d75b9d0-ff46-f424-e053-dadaa90a57ce	Urticaria - Rashes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-4529-1	Urticaria - Rashes	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35		1
55714-4529-2	Urticaria - Rashes	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
55714-4529	URTICARIA - RASHES (ANTIMON. CRUD., APIS MEL., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM, MEZEREUM , NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.) PELLET [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20131107_fe5db88c-8b7e-b090-096b-668f6fee44ba.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Antimony Trisulfide	ACTIVE INGREDIENT	F79059A38U	1
Apis Mellifera	ACTIVE INGREDIENT	7S82P3R43Z	1
Arsenic Trioxide	ACTIVE INGREDIENT	S7V92P67HO	1
Berberis Vulgaris Root Bark	ACTIVE INGREDIENT	1TH8Q20J0U	1
Bryonia Alba Root	ACTIVE INGREDIENT	T7J046YI2B	1
Chelidonium Majus	ACTIVE INGREDIENT	7E889U5RNN	1
Croton Tiglium Seed	ACTIVE INGREDIENT	0HK2GZK66E	1
Daphne Mezereum Bark	ACTIVE INGREDIENT	X2N6E405GV	1
Echinacea, Unspecified	ACTIVE INGREDIENT	4N9P6CC1DX	1
Giant Puffball	ACTIVE INGREDIENT	I6839Y031A	1
Graphite	ACTIVE INGREDIENT	4QQN74LH4O	1
Histamine Dihydrochloride	ACTIVE INGREDIENT	3POA0Q644U	1
Kerosene	ACTIVE INGREDIENT	1C89KKC04E	1
Lycopodium Clavatum Spore	ACTIVE INGREDIENT	C88X29Y479	1
Lytta Vesicatoria	ACTIVE INGREDIENT	3Q034RO3BT	1
Pulex Irritans	ACTIVE INGREDIENT	L63DD62R8R	1
Pulsatilla Vulgaris	ACTIVE INGREDIENT	I76KB35JEV	1
Rumex Crispus Root	ACTIVE INGREDIENT	9N1RM2S62C	1
Smilax Regelii Root	ACTIVE INGREDIENT	2H1576D5WG	1
Solanum Dulcamara Top	ACTIVE INGREDIENT	KPS1B1162N	1
Strychnos Nux-vomica Seed	ACTIVE INGREDIENT	269XH13919	1
Sulfur	ACTIVE INGREDIENT	70FD1KFU70	1
Taraxacum Officinale	ACTIVE INGREDIENT	39981FM375	1
Toxicodendron Pubescens Leaf	ACTIVE INGREDIENT	6IO182RP7A	1
Urtica Urens	ACTIVE INGREDIENT	IHN2NQ5OF9	1
Antimony Trisulfide	ACTIVE MOIETY	F79059A38U	1
Apis Mellifera	ACTIVE MOIETY	7S82P3R43Z	1
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	1
Berberis Vulgaris Root Bark	ACTIVE MOIETY	1TH8Q20J0U	1
Bryonia Alba Root	ACTIVE MOIETY	T7J046YI2B	1
Chelidonium Majus	ACTIVE MOIETY	7E889U5RNN	1
Croton Tiglium Seed	ACTIVE MOIETY	0HK2GZK66E	1
Daphne Mezereum Bark	ACTIVE MOIETY	X2N6E405GV	1
Echinacea, Unspecified	ACTIVE MOIETY	4N9P6CC1DX	1
Giant Puffball	ACTIVE MOIETY	I6839Y031A	1
Graphite	ACTIVE MOIETY	4QQN74LH4O	1
Histamine	ACTIVE MOIETY	820484N8I3	1
Kerosene	ACTIVE MOIETY	1C89KKC04E	1
Lycopodium Clavatum Spore	ACTIVE MOIETY	C88X29Y479	1
Lytta Vesicatoria	ACTIVE MOIETY	3Q034RO3BT	1
Pulex Irritans	ACTIVE MOIETY	L63DD62R8R	1
Pulsatilla Vulgaris	ACTIVE MOIETY	I76KB35JEV	1
Rumex Crispus Root	ACTIVE MOIETY	9N1RM2S62C	1
Smilax Regelii Root	ACTIVE MOIETY	2H1576D5WG	1
Solanum Dulcamara Top	ACTIVE MOIETY	KPS1B1162N	1
Strychnos Nux-vomica Seed	ACTIVE MOIETY	269XH13919	1
Sulfur	ACTIVE MOIETY	70FD1KFU70	1
Taraxacum Officinale	ACTIVE MOIETY	39981FM375	1
Toxicodendron Pubescens Leaf	ACTIVE MOIETY	6IO182RP7A	1
Urtica Urens	ACTIVE MOIETY	IHN2NQ5OF9	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.

Urticaria - Rashes
Antimon. crud., Apis mel., Arsenicum alb., Berber. vulg., Bovista, Bryonia, Cantharis, Chelidonium majus, Croton, Dulcamara, Graphites, Histaminum hydrochloricum, Lycopodium, Mezereum , Nux vom., Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur.
Antimony Trisulfide
Apis Mellifera
Arsenic Trioxide
Arsenic Cation (3+)
Berberis Vulgaris Root Bark
Giant Puffball
Bryonia Alba Root
Lytta Vesicatoria
Chelidonium Majus
Croton Tiglium Seed
Solanum Dulcamara Top
Graphite
Histamine Dihydrochloride
Histamine
Lycopodium Clavatum Spore
Daphne Mezereum Bark
Strychnos Nux-vomica Seed
Kerosene
Pulex Irritans
Pulsatilla Vulgaris
Toxicodendron Pubescens Leaf
Smilax Regelii Root
Sulfur
Echinacea, Unspecified
Rumex Crispus Root
Taraxacum Officinale
Urtica Urens
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-4529	55714-4529-1, 55714-4529-2

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
Antimony Trisulfide	F79059A38U	ACTIB
Apis Mellifera	7S82P3R43Z	ACTIB
Arsenic Trioxide	S7V92P67HO	ACTIB
Berberis Vulgaris Root Bark	1TH8Q20J0U	ACTIB
Giant Puffball	I6839Y031A	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Lytta Vesicatoria	3Q034RO3BT	ACTIB
Chelidonium Majus	7E889U5RNN	ACTIB
Croton Tiglium Seed	0HK2GZK66E	ACTIB
Solanum Dulcamara Top	KPS1B1162N	ACTIB
Graphite	4QQN74LH4O	ACTIB
Histamine Dihydrochloride	3POA0Q644U	ACTIB
Lycopodium Clavatum Spore	C88X29Y479	ACTIB
Daphne Mezereum Bark	X2N6E405GV	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Kerosene	1C89KKC04E	ACTIB
Pulex Irritans	L63DD62R8R	ACTIB
Pulsatilla Vulgaris	I76KB35JEV	ACTIB
Toxicodendron Pubescens Leaf	6IO182RP7A	ACTIB
Smilax Regelii Root	2H1576D5WG	ACTIB
Sulfur	70FD1KFU70	ACTIB
Echinacea, Unspecified	4N9P6CC1DX	ACTIB
Rumex Crispus Root	9N1RM2S62C	ACTIB
Taraxacum Officinale	39981FM375	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	SUPPOSITORY / RECTAL	NA		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	TABLET / BUCCAL	109 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	POWDER, FOR SUSPENSION / ORAL		40017 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	INJECTION, EMULSION / INTRAVENOUS		970 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	INJECTION / SUBCUTANEOUS	47.75 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	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 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	LIQUID / ORAL		37500 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	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		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	CAPSULE / ORAL		3568 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
Sucrose	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 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	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		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	LOZENGE / TRANSMUCOSAL		1255 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	TROCHE / BUCCAL	NA		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	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 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 SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	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, EXTENDED RELEASE / ORAL		619 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	TABLET, CHEWABLE / ORAL		7258 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	POWDER / ORAL		27768 mg	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	GRANULE / ORAL	NA		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	TABLET / ORAL		4249 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	SYRUP / ORAL		46400 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 / SUBLINGUAL	109 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	SUSPENSION / ORAL		48209 mg	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	GRANULE, FOR SOLUTION / ORAL		42596 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

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
45be7737-ffd6-b42b-a989-26a101697b54			fe5db88c-8b7e-b090-096b-668f6fee44ba	2011-06-01	Warnings	Exact identifier spl id: 45be7737-ffd6-b42b-a989-26a101697b54 spl set id: fe5db88c-8b7e-b090-096b-668f6fee44ba

Reported adverse events (FAERS/openFDA)#

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