FDA.reportPublic FDA data

Cold Sores

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:49

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, ANEMONE PULSATILLA, RANUNCULUS BULBOSUS, TOXICODENDRON PUBESCENS LEAF, SMILAX ORNATA ROOT, SEPIA OFFICINALIS JUICE, SULFUR, THUJA OCCIDENTALIS LEAFY TWIG, ECHINACEA, UNSPECIFIED, HYPERICUM PERFORATUM
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Hypericum 6x, Arsenicum alb. 15x, Bryonia 15x, Cantharis 15x, Chelidonium majus 15x, Cistus canadensis 15x, Conium 15x, Croton 15x, Dulcamara 15x, Graphites 15x, Kali bic.15x, Lycopodium 15x, Mezereum 15x, Nux vom. 15x, Petroleum 15x, Pulsatilla 15x, Ranunc. bulb. 15x, Rhus toxicodendron 15x, Sarsaparilla 15x, Sepia 15x, Sulphur 15x, Thuja occ. 15x.

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 alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2408-1Cold Sores30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2408COLD 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.]2Current NDC, Legacy NDC, 1 package rows20250209_9b952b77-d172-1828-e053-2a95a90ab4f6.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-240855714-2408-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
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
ANEMONE PULSATILLAI76KB35JEVACTIB
RANUNCULUS BULBOSUSAEQ8NXJ0MBACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SMILAX ORNATA ROOT2H1576D5WGACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SULFUR70FD1KFU70ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

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
Cold SoresARSENICUM 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, HYPERICUMNewton Laboratories, Inc.9b952b77-d172-1828-e053-2a95a90ab4f62025-02-06WarningsExact identifier
ndc (package): 55714-2408-1
ndc (product): 55714-2408
ndc11 (package): 55714240801
spl id: 2d813d91-7acb-7366-e063-6294a90ad6c2
spl set id: 9b952b77-d172-1828-e053-2a95a90ab4f6

Reported adverse events (FAERS/openFDA)#

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