FDA.reportPublic FDA data

Urticaria - Rashes

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:05:27

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

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

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:  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.

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

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
55714-4528-12020-01-31C16284748780-19d75b9d1-2583-f424-e053-dadaa90a57ceUrticaria - Rashes
55714-4528-22020-01-31C16284748780-19d75b9d1-2583-f424-e053-dadaa90a57ceUrticaria - Rashes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4528-1Urticaria - Rashes29.57 mL in 1 BOTTLE, GLASSLIQUID29.573
55714-4528-2Urticaria - Rashes59.14 mL in 1 BOTTLE, GLASSLIQUID59.143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4528URTICARIA - 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.) LIQUID [NEWTON LABORATORIES, INC.]3Legacy NDC, 2 package rows20140211_51e30fb2-626c-248e-5b35-14904f7142aa.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Antimony TrisulfideACTIVE INGREDIENTF79059A38U3
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z3
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO3
Berberis Vulgaris Root BarkACTIVE INGREDIENT1TH8Q20J0U3
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B3
Chelidonium MajusACTIVE INGREDIENT7E889U5RNN3
Croton Tiglium SeedACTIVE INGREDIENT0HK2GZK66E3
Daphne Mezereum BarkACTIVE INGREDIENTX2N6E405GV3
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX3
Giant PuffballACTIVE INGREDIENTI6839Y031A3
GraphiteACTIVE INGREDIENT4QQN74LH4O3
Histamine DihydrochlorideACTIVE INGREDIENT3POA0Q644U3
KeroseneACTIVE INGREDIENT1C89KKC04E3
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4793
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT3
Pulex IrritansACTIVE INGREDIENTL63DD62R8R3
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV3
Rumex Crispus RootACTIVE INGREDIENT9N1RM2S62C3
Smilax Regelii RootACTIVE INGREDIENT2H1576D5WG3
Solanum Dulcamara TopACTIVE INGREDIENTKPS1B1162N3
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139193
SulfurACTIVE INGREDIENT70FD1KFU703
Taraxacum OfficinaleACTIVE INGREDIENT39981FM3753
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A3
Urtica UrensACTIVE INGREDIENTIHN2NQ5OF93
Antimony TrisulfideACTIVE MOIETYF79059A38U3
Apis MelliferaACTIVE MOIETY7S82P3R43Z3
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV3
Berberis Vulgaris Root BarkACTIVE MOIETY1TH8Q20J0U3
Bryonia Alba RootACTIVE MOIETYT7J046YI2B3
Chelidonium MajusACTIVE MOIETY7E889U5RNN3
Croton Tiglium SeedACTIVE MOIETY0HK2GZK66E3
Daphne Mezereum BarkACTIVE MOIETYX2N6E405GV3
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX3
Giant PuffballACTIVE MOIETYI6839Y031A3
GraphiteACTIVE MOIETY4QQN74LH4O3
HistamineACTIVE MOIETY820484N8I33
KeroseneACTIVE MOIETY1C89KKC04E3
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4793
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT3
Pulex IrritansACTIVE MOIETYL63DD62R8R3
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV3
Rumex Crispus RootACTIVE MOIETY9N1RM2S62C3
Smilax Regelii RootACTIVE MOIETY2H1576D5WG3
Solanum Dulcamara TopACTIVE MOIETYKPS1B1162N3
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139193
SulfurACTIVE MOIETY70FD1KFU703
Taraxacum OfficinaleACTIVE MOIETY39981FM3753
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A3
Urtica UrensACTIVE MOIETYIHN2NQ5OF93
AlcoholINACTIVE INGREDIENT3K9958V90M3

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
55714-452855714-4528-1, 55714-4528-2

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
NameUNIIKind
Antimony TrisulfideF79059A38UACTIB
Apis Mellifera7S82P3R43ZACTIB
Arsenic TrioxideS7V92P67HOACTIB
Berberis Vulgaris Root Bark1TH8Q20J0UACTIB
Giant PuffballI6839Y031AACTIB
Bryonia Alba RootT7J046YI2BACTIB
Lytta Vesicatoria3Q034RO3BTACTIB
Chelidonium Majus7E889U5RNNACTIB
Croton Tiglium Seed0HK2GZK66EACTIB
Solanum Dulcamara TopKPS1B1162NACTIB
Graphite4QQN74LH4OACTIB
Histamine Dihydrochloride3POA0Q644UACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Daphne Mezereum BarkX2N6E405GVACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Kerosene1C89KKC04EACTIB
Pulex IrritansL63DD62R8RACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Smilax Regelii Root2H1576D5WGACTIB
Sulfur70FD1KFU70ACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Rumex Crispus Root9N1RM2S62CACTIB
Taraxacum Officinale39981FM375ACTIB
Urtica UrensIHN2NQ5OF9ACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML · Source PDF

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
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact 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
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact 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
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 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
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 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
9b569529-3b0b-568d-c042-07401519e73851e30fb2-626c-248e-5b35-14904f7142aa2011-06-01WarningsExact identifier
spl id: 9b569529-3b0b-568d-c042-07401519e738
spl set id: 51e30fb2-626c-248e-5b35-14904f7142aa

Reported adverse events (FAERS/openFDA)#

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