FDA.reportPublic FDA data

Cold Sores

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:48

Label at a glance#

ProductCold Sores
Active ingredientArsenic Trioxide, Bryonia Alba Root, Lytta Vesicatoria, Chelidonium Majus, Helianthemum Canadense, Conium Maculatum Flowering Top, Croton Tiglium Seed, Solanum Dulcamara Top, Graphite, Potassium Dichromate, Lycopodium Clavatum Spore, Daphne Mezereum Bark, Strychnos Nux-vomica Seed, Kerosene, Pulsatilla Vulgaris, Ranunculus Bulbosus, Toxicodendron Pubescens Leaf, Smilax Regelii Root, Sepia Officinalis Juice, Sulfur, Thuja Occidentalis Leafy Twig, Echinacea, Unspecified, Hypericum Perforatum
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Cold Sores  Formulated for symptoms associated with eruptions and sores of the lips and mouth such as itching, crusting, redness and pain.

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. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Arsenicum alb. 10x, Bryonia 10x, Cantharis 10x, Chelidonium majus 10x, Cistus canadensis 10x, Conium 10x, Croton 10x, Dulcamara 10x, Graphites 10x, Kali bic.10x, Lycopodium 10x, Mezereum 10x, Nux vom. 10x, Petroleum 10x, Pulsatilla 10x, Ranunc. bulb. 10x, Rhus toxicodendron 10x, Sarsaparilla 10x, Sepia 10x, Sulphur 10x, Thuja occ. 10x, Echinacea 3x, Hypericum 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with eruptions and sores of the lips and mouth such as itching, crusting, redness and pain.

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, GA30012
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

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
55714-2276-02020-01-31C16284748780-19d75b9d0-c2b6-f424-e053-dadaa90a57ceCold Sores
55714-2276-12020-01-31C16284748780-19d75b9d0-c2b6-f424-e053-dadaa90a57ceCold Sores
55714-2276-22020-01-31C16284748780-19d75b9d0-c2b6-f424-e053-dadaa90a57ceCold Sores

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2276-0Cold Sores.5 mL in 1 BOTTLE, GLASSLIQUID.52
55714-2276-1Cold Sores29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-2276-2Cold Sores59.14 mL in 1 BOTTLE, GLASSLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2276COLD SORES (ARSENICUM ALB., BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CISTUS CANADENSIS, CONIUM, CROTON, DULCAMARA, GRAPHITES, KALI BIC., LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULSATILLA, RANUNC. BULB., RHUS TOXICODENDRON, SARSAPARILLA, SEPIA, SULPHUR, THUJA OCC., ECHINACEA, HYPERICUM) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 3 package rows20130802_f7579a33-7523-53bc-9980-4bd62d277e89.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO2
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
Chelidonium MajusACTIVE INGREDIENT7E889U5RNN2
Conium Maculatum Flowering TopACTIVE INGREDIENTQ28R5GF3712
Croton Tiglium SeedACTIVE INGREDIENT0HK2GZK66E2
Daphne Mezereum BarkACTIVE INGREDIENTX2N6E405GV2
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX2
GraphiteACTIVE INGREDIENT4QQN74LH4O2
Helianthemum CanadenseACTIVE INGREDIENT46G3W789Q32
Hypericum PerforatumACTIVE INGREDIENTXK4IUX8MNB2
KeroseneACTIVE INGREDIENT1C89KKC04E2
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4792
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT2
Potassium DichromateACTIVE INGREDIENTT4423S18FM2
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV2
Ranunculus BulbosusACTIVE INGREDIENTAEQ8NXJ0MB2
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C22
Smilax Regelii RootACTIVE INGREDIENT2H1576D5WG2
Solanum Dulcamara TopACTIVE INGREDIENTKPS1B1162N2
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139192
SulfurACTIVE INGREDIENT70FD1KFU702
Thuja Occidentalis Leafy TwigACTIVE INGREDIENT1NT28V93972
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A2
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV2
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Chelidonium MajusACTIVE MOIETY7E889U5RNN2
Conium Maculatum Flowering TopACTIVE MOIETYQ28R5GF3712
Croton Tiglium SeedACTIVE MOIETY0HK2GZK66E2
Daphne Mezereum BarkACTIVE MOIETYX2N6E405GV2
Dichromate IonACTIVE MOIETY9LKY4BFN2V2
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX2
GraphiteACTIVE MOIETY4QQN74LH4O2
Helianthemum CanadenseACTIVE MOIETY46G3W789Q32
Hypericum PerforatumACTIVE MOIETYXK4IUX8MNB2
KeroseneACTIVE MOIETY1C89KKC04E2
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4792
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT2
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV2
Ranunculus BulbosusACTIVE MOIETYAEQ8NXJ0MB2
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C22
Smilax Regelii RootACTIVE MOIETY2H1576D5WG2
Solanum Dulcamara TopACTIVE MOIETYKPS1B1162N2
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139192
SulfurACTIVE MOIETY70FD1KFU702
Thuja Occidentalis Leafy TwigACTIVE MOIETY1NT28V93972
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A2
AlcoholINACTIVE INGREDIENT3K9958V90M2

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-227655714-2276-1, 55714-2276-2, 55714-2276-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
Arsenic TrioxideS7V92P67HOACTIB
Bryonia Alba RootT7J046YI2BACTIB
Lytta Vesicatoria3Q034RO3BTACTIB
Chelidonium Majus7E889U5RNNACTIB
Helianthemum Canadense46G3W789Q3ACTIB
Conium Maculatum Flowering TopQ28R5GF371ACTIB
Croton Tiglium Seed0HK2GZK66EACTIB
Solanum Dulcamara TopKPS1B1162NACTIB
Graphite4QQN74LH4OACTIB
Potassium DichromateT4423S18FMACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Daphne Mezereum BarkX2N6E405GVACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Kerosene1C89KKC04EACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Ranunculus BulbosusAEQ8NXJ0MBACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Smilax Regelii Root2H1576D5WGACTIB
Sepia Officinalis JuiceQDL83WN8C2ACTIB
Sulfur70FD1KFU70ACTIB
Thuja Occidentalis Leafy Twig1NT28V9397ACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Hypericum PerforatumXK4IUX8MNBACTIB
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
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 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 / ORAL6624 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
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact 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

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
8d6c7169-b7d4-0d60-6558-97efb8c7d680f7579a33-7523-53bc-9980-4bd62d277e892011-03-01WarningsExact identifier
spl id: 8d6c7169-b7d4-0d60-6558-97efb8c7d680
spl set id: f7579a33-7523-53bc-9980-4bd62d277e89

Reported adverse events (FAERS/openFDA)#

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