Home NDC 83027-0303-1 Cold Sore Formula
Product NDC 83027-0303
Requested package NDC 83027-0303-1
11-digit product format 830270303
Labeler code 83027
Product ID 83027-0303_b985df4b-c2ff-40bf-9d3f-a425781d3354
Type HUMAN OTC DRUG
Nonproprietary name Dulcamara, Glycyrrhiza Glabra, Ranunculus Bulbosus, Rhus Tox, Natrum Muriaticum, Fagopyrum Esculentum, Natrum Hypochlorous, 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 2026-03-31
Substance SOLANUM DULCAMARA TOP; GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER; RANUNCULUS BULBOSUS WHOLE; TOXICODENDRON PUBESCENS LEAF; SODIUM CHLORIDE; FAGOPYRUM ESCULENTUM WHOLE; SODIUM HYPOCHLORITE; ACONITUM NAPELLUS WHOLE; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; SEPIA OFFICINALIS JUICE; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 3; HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN
Active strength 3; 3; 3; 5; 6; 8; 12; 15; 15; 20; 20; 30; 15; 18; 20 [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_C]/mL; [hp_C]/mL; [hp_C]/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
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Cold Sore Formula
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SOLANUM DULCAMARA TOP 3 [hp_X]/mL GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER 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 20 [hp_X]/mL HUMAN HERPESVIRUS 2 20 [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 83027-0303-1 Cold Sore Formula 60 mL in 1 BOTTLE, SPRAY SPRAY 60 1
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 HYPOCHLOROUS, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODE Nutritional Specialties, Inc. ad6a08ec-5eba-405b-8a07-79ac86ab3e7a 2026-03-31 Warnings Exact identifier ndc (package): 83027-0303-1 ndc (product): 83027-0303 ndc11 (package): 83027030301
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83027-0303-1 83027030301 60 mL in 1 BOTTLE, SPRAY (83027-0303-1) 60 ml 2026-03-31 No No Current