Home NDC 83027-0007 Cold Sore Formula
Product NDC 83027-0007
11-digit product format 830270007
Labeler code 83027
Product ID 83027-0007_3fa008ed-7e39-4a5e-a1eb-f76ffa523573
Type HUMAN OTC DRUG
Nonproprietary name Dulcamara, Glycyrrhiza Glabra, Ranunculus Bulbosus, Rhus Tox, Natrum Muriaticum, Fagopyrum Esculentum, Natrum Muriaticum, Aconitum Napellus, Cytomegalovirus Nosode, Herpes Simplex I and II Nosode, Sepia, Epstein Barr Virus Nosode, Herpes Zoster Nosode, Adenoviren Nosode
Dosage form SPRAY
Route ORAL
Labeler Nutritional Specialties, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2023-03-30
Marketing end 2029-10-25
Substance ACONITUM NAPELLUS WHOLE; FAGOPYRUM ESCULENTUM WHOLE; GLYCYRRHIZA GLABRA; HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 3; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 5; RANUNCULUS BULBOSUS WHOLE; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; SODIUM HYPOCHLORITE; SOLANUM DULCAMARA TOP; TOXICODENDRON PUBESCENS LEAF
Active strength 15; 8; 3; 20; 18; 18; 18; 15; 15; 3; 30; 6; 12; 3; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes Actively Acquired Immunity [PE], Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Live Human Adenovirus Type 4 Vaccine [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vaccines, Adenovirus [Chemical/Ingredient], Vaccines, Live, Unattenuated [Chemical/Ingredient]
NDC exclude flag No
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Cold Sore Formula Active Ingredients# Ingredient, Strength table Ingredient Strength SOLANUM DULCAMARA TOP 3 [hp_X]/mL GLYCYRRHIZA GLABRA 3 [hp_X]/mL RANUNCULUS BULBOSUS WHOLE 3 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF 5 [hp_X]/mL SODIUM CHLORIDE 6 [hp_X]/mL FAGOPYRUM ESCULENTUM WHOLE 8 [hp_X]/mL SODIUM HYPOCHLORITE 12 [hp_X]/mL ACONITUM NAPELLUS WHOLE 15 [hp_X]/mL HUMAN HERPESVIRUS 5 15 [hp_X]/mL HUMAN HERPESVIRUS 1 18 [hp_X]/mL HUMAN HERPESVIRUS 2 18 [hp_X]/mL SEPIA OFFICINALIS JUICE 30 [hp_X]/mL HUMAN HERPESVIRUS 4 15 [hp_C]/mL HUMAN HERPESVIRUS 3 18 [hp_C]/mL HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN 20 [hp_C]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 15 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 83027-0007-1 Cold Sore Formula 60 mL in 1 BOTTLE, SPRAY SPRAY 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83027-0007 COLD SORE FORMULA (DULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM MURIATICUM, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODE) SPRAY [NUTRITIONAL SPECIALTIES, INC.] 2 Current NDC, 1 package rows 20241102_f4e7e469-baaf-4c61-af44-80b0832eadf0.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 Sore Formula DULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM MURIATICUM, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODE Nutritional Specialties, Inc. f4e7e469-baaf-4c61-af44-80b0832eadf0 2026-03-31 Warnings Exact identifier ndc (product): 83027-0007
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 83027-0007-1 83027000701 60 mL in 1 BOTTLE, SPRAY (83027-0007-1) 60 ml 2023-03-30 2029-10-25 No No Historical