Cold Sores

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 02:05:02

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

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

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: 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. Sensitive persons begin with 1 pellet 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: 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
55714-2277-0	2020-01-31	C162847	48780-1	9d75b9d0-8410-f424-e053-dadaa90a57ce	Cold Sores
55714-2277-1	2020-01-31	C162847	48780-1	9d75b9d0-8410-f424-e053-dadaa90a57ce	Cold Sores
55714-2277-2	2020-01-31	C162847	48780-1	9d75b9d0-8410-f424-e053-dadaa90a57ce	Cold Sores

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55714-2277-0	Cold Sores	7.08 g in 1 BOTTLE, GLASS	PELLET	7.08	1
55714-2277-1	Cold Sores	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35	1
55714-2277-2	Cold Sores	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
55714-2277	COLD 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) PELLET [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 3 package rows	20131016_936cc67b-1d86-374c-ec0a-0c8b2943a172.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Arsenic Trioxide	ACTIVE INGREDIENT	S7V92P67HO	1
Bryonia Alba Root	ACTIVE INGREDIENT	T7J046YI2B	1
Chelidonium Majus	ACTIVE INGREDIENT	7E889U5RNN	1
Conium Maculatum Flowering Top	ACTIVE INGREDIENT	Q28R5GF371	1
Croton Tiglium Seed	ACTIVE INGREDIENT	0HK2GZK66E	1
Daphne Mezereum Bark	ACTIVE INGREDIENT	X2N6E405GV	1
Echinacea, Unspecified	ACTIVE INGREDIENT	4N9P6CC1DX	1
Graphite	ACTIVE INGREDIENT	4QQN74LH4O	1
Helianthemum Canadense	ACTIVE INGREDIENT	46G3W789Q3	1
Hypericum Perforatum	ACTIVE INGREDIENT	XK4IUX8MNB	1
Kerosene	ACTIVE INGREDIENT	1C89KKC04E	1
Lycopodium Clavatum Spore	ACTIVE INGREDIENT	C88X29Y479	1
Lytta Vesicatoria	ACTIVE INGREDIENT	3Q034RO3BT	1
Potassium Dichromate	ACTIVE INGREDIENT	T4423S18FM	1
Pulsatilla Vulgaris	ACTIVE INGREDIENT	I76KB35JEV	1
Ranunculus Bulbosus	ACTIVE INGREDIENT	AEQ8NXJ0MB	1
Sepia Officinalis Juice	ACTIVE INGREDIENT	QDL83WN8C2	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
Thuja Occidentalis Leafy Twig	ACTIVE INGREDIENT	1NT28V9397	1
Toxicodendron Pubescens Leaf	ACTIVE INGREDIENT	6IO182RP7A	1
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	1
Bryonia Alba Root	ACTIVE MOIETY	T7J046YI2B	1
Chelidonium Majus	ACTIVE MOIETY	7E889U5RNN	1
Conium Maculatum Flowering Top	ACTIVE MOIETY	Q28R5GF371	1
Croton Tiglium Seed	ACTIVE MOIETY	0HK2GZK66E	1
Daphne Mezereum Bark	ACTIVE MOIETY	X2N6E405GV	1
Dichromate Ion	ACTIVE MOIETY	9LKY4BFN2V	1
Echinacea, Unspecified	ACTIVE MOIETY	4N9P6CC1DX	1
Graphite	ACTIVE MOIETY	4QQN74LH4O	1
Helianthemum Canadense	ACTIVE MOIETY	46G3W789Q3	1
Hypericum Perforatum	ACTIVE MOIETY	XK4IUX8MNB	1
Kerosene	ACTIVE MOIETY	1C89KKC04E	1
Lycopodium Clavatum Spore	ACTIVE MOIETY	C88X29Y479	1
Lytta Vesicatoria	ACTIVE MOIETY	3Q034RO3BT	1
Pulsatilla Vulgaris	ACTIVE MOIETY	I76KB35JEV	1
Ranunculus Bulbosus	ACTIVE MOIETY	AEQ8NXJ0MB	1
Sepia Officinalis Juice	ACTIVE MOIETY	QDL83WN8C2	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
Thuja Occidentalis Leafy Twig	ACTIVE MOIETY	1NT28V9397	1
Toxicodendron Pubescens Leaf	ACTIVE MOIETY	6IO182RP7A	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

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

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

Cold 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
Arsenic Trioxide
Arsenic Cation (3+)
Bryonia Alba Root
Lytta Vesicatoria
Chelidonium Majus
Helianthemum Canadense
Conium Maculatum Flowering Top
Croton Tiglium Seed
Solanum Dulcamara Top
Graphite
Potassium Dichromate
Dichromate Ion
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
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-2277	55714-2277-1, 55714-2277-2, 55714-2277-0

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
Name	UNII	Kind
Arsenic Trioxide	S7V92P67HO	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Lytta Vesicatoria	3Q034RO3BT	ACTIB
Chelidonium Majus	7E889U5RNN	ACTIB
Helianthemum Canadense	46G3W789Q3	ACTIB
Conium Maculatum Flowering Top	Q28R5GF371	ACTIB
Croton Tiglium Seed	0HK2GZK66E	ACTIB
Solanum Dulcamara Top	KPS1B1162N	ACTIB
Graphite	4QQN74LH4O	ACTIB
Potassium Dichromate	T4423S18FM	ACTIB
Lycopodium Clavatum Spore	C88X29Y479	ACTIB
Daphne Mezereum Bark	X2N6E405GV	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Kerosene	1C89KKC04E	ACTIB
Pulsatilla Vulgaris	I76KB35JEV	ACTIB
Ranunculus Bulbosus	AEQ8NXJ0MB	ACTIB
Toxicodendron Pubescens Leaf	6IO182RP7A	ACTIB
Smilax Regelii Root	2H1576D5WG	ACTIB
Sepia Officinalis Juice	QDL83WN8C2	ACTIB
Sulfur	70FD1KFU70	ACTIB
Thuja Occidentalis Leafy Twig	1NT28V9397	ACTIB
Echinacea, Unspecified	4N9P6CC1DX	ACTIB
Hypericum Perforatum	XK4IUX8MNB	ACTIB
Sucrose	C151H8M554	IACT

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 · 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	CAPSULE / ORAL		3568 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	TROCHE / BUCCAL	NA		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	SOLUTION / RECTAL	35.42 %w/v		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	LIQUID / ORAL		37500 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	TABLET, EXTENDED RELEASE / ORAL	284.54 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	SOLUTION / ORAL		70000 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	INJECTION, SOLUTION / INTRAVENOUS	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	WAFER / ORAL	155.2 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	TABLET / BUCCAL	109 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	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	CAPSULE, EXTENDED RELEASE / ORAL		619 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	INJECTION / SUBCUTANEOUS	47.75 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	INJECTION / INTRAVENOUS		1950 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	SYRUP / ORAL		46400 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	TROCHE / ORAL	NA		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	PASTILLE / ORAL	426 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	CAPSULE, COATED PELLETS / ORAL	59.8 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	SUSPENSION, EXTENDED RELEASE / ORAL		5400 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	GRANULE / ORAL	NA		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 / SUBLINGUAL	109 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	SUSPENSION/ DROPS / ORAL		3750 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	DROPS / ORAL	NA		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	INJECTION, EMULSION / INTRAVENOUS		970 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

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
cc0a55eb-6c5d-997d-0ddf-58cdb956fe39			936cc67b-1d86-374c-ec0a-0c8b2943a172	2011-03-01	Warnings	Exact identifier spl id: cc0a55eb-6c5d-997d-0ddf-58cdb956fe39 spl set id: 936cc67b-1d86-374c-ec0a-0c8b2943a172

Reported adverse events (FAERS/openFDA)#

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