Cold Sores

Product NDC
55714-2408
11-digit product format
557142408
Labeler code
55714
Product ID
55714-2408_2d813d91-7acb-7366-e063-6294a90ad6c2
Type
HUMAN OTC DRUG
Nonproprietary name
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
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-01-01
Substance
ANEMONE PULSATILLA; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GRAPHITE; HELIANTHEMUM CANADENSE; HYPERICUM PERFORATUM; KEROSENE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; POTASSIUM DICHROMATE; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SMILAX ORNATA ROOT; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF
Active strength
15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Sores
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANEMONE PULSATILLA15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
CHELIDONIUM MAJUS15 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP15 [hp_X]/mL
CROTON TIGLIUM SEED15 [hp_X]/mL
DAPHNE MEZEREUM BARK15 [hp_X]/mL
ECHINACEA, UNSPECIFIED6 [hp_X]/mL
GRAPHITE15 [hp_X]/mL
HELIANTHEMUM CANADENSE15 [hp_X]/mL
HYPERICUM PERFORATUM6 [hp_X]/mL
KEROSENE15 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/mL
LYTTA VESICATORIA15 [hp_X]/mL
POTASSIUM DICHROMATE15 [hp_X]/mL
RANUNCULUS BULBOSUS15 [hp_X]/mL
SEPIA OFFICINALIS JUICE15 [hp_X]/mL
SMILAX ORNATA ROOT15 [hp_X]/mL
SOLANUM DULCAMARA TOP15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
SULFUR15 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG15 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI76KB35JEV, S7V92P67HO, T7J046YI2B, 7E889U5RNN, Q28R5GF371, 0HK2GZK66E, X2N6E405GV, 4N9P6CC1DX, 4QQN74LH4O, 46G3W789Q3, XK4IUX8MNB, 1C89KKC04E, C88X29Y479, 3Q034RO3BT, T4423S18FM, AEQ8NXJ0MB, QDL83WN8C2, 2H1576D5WG, KPS1B1162N, 269XH13919

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2408-15571424080130 mL in 1 BOTTLE, GLASS (55714-2408-1) 30 ml2019-01-010000-00-00NoNoCurrent