Home NDC 55714-2408 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55714-2408-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55714-2408-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55714-2408-1 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Cold Sores
Listing expiration 2026-12-31
Active Ingredients# Ingredient, Strength table Ingredient Strength ARSENIC TRIOXIDE 15 [hp_X]/mL BRYONIA ALBA ROOT 15 [hp_X]/mL LYTTA VESICATORIA 15 [hp_X]/mL CHELIDONIUM MAJUS 15 [hp_X]/mL HELIANTHEMUM CANADENSE 15 [hp_X]/mL CONIUM MACULATUM FLOWERING TOP 15 [hp_X]/mL CROTON TIGLIUM SEED 15 [hp_X]/mL SOLANUM DULCAMARA TOP 6 [hp_X]/mL GRAPHITE 15 [hp_X]/mL POTASSIUM DICHROMATE 15 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE 6 [hp_X]/mL DAPHNE MEZEREUM BARK 15 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/mL KEROSENE 15 [hp_X]/mL ANEMONE PULSATILLA 15 [hp_X]/mL RANUNCULUS BULBOSUS 15 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF 15 [hp_X]/mL SMILAX ORNATA ROOT 15 [hp_X]/mL SEPIA OFFICINALIS JUICE 15 [hp_X]/mL SULFUR 15 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG 15 [hp_X]/mL ECHINACEA, UNSPECIFIED 15 [hp_X]/mL HYPERICUM PERFORATUM 15 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 23 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55714-2408-1 Cold Sores 30 mL in 1 BOTTLE, GLASS LIQUID 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55714-2408 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) LIQUID [NEWTON LABORATORIES, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20250209_9b952b77-d172-1828-e053-2a95a90ab4f6.zip
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 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 Newton Laboratories, Inc. 9b952b77-d172-1828-e053-2a95a90ab4f6 2025-02-06 Warnings Exact identifier ndc (product): 55714-2408
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55714-2408-1 55714240801 30 mL in 1 BOTTLE, GLASS (55714-2408-1) 30 ml 2019-01-01 0000-00-00 No No Current