Cold Sore Formula

Manufacturer
Nutritional Specialties, Inc.
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:38:16

Label at a glance#

ProductCold Sore Formula
Active ingredientSOLANUM DULCAMARA TOP, GLYCYRRHIZA GLABRA, 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
Label structure9 sections

Indications and uses

Assists in relieving the symptoms of cold sores including •blistering, •dry cracked skin, •pustules, and the •pain, •burning, •itching associated with the same.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• Adults: Acute 2 to 3 sprays orally every hour, up to 48 hours. Then 2 to 3 sprays three times per day. Chronic and maintenance 1 to 2 sprays       four times daily. Can be sprayed directly on afflicted areas in conjunction with oral use. Children under twelve one half adult dosage. • Do not take within 15 minutes of consuming food, beverage or brushing teeth. • Consult a physician for use in children under 12 ye...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each teaspoon) Aconitum Napellus 15X, 30X, 60X, 200X, Adenoviren Nosode 20C, 30C, 60C, 200C, Cytomegalovirus Nosode 15X, 30X, 60X, 200X, Dulcamara 3X, Epstein-Barr Virus Nosode 15C, 30C, 60C, 200C, Fagopyrum Esculentum 8X, Glycyrrhiza Glabra 3X, Herpes Simplex I and II Nosode 18X, 30X, 60X, 200X, Herpes Zoster Nosode 18C, 30C, 60C, 200C, Natrum Hypochlorosum 12X, Natrum Muriaticum 6X, 30X, Ranunculus Bulbosus 3X, Rhus Tox 5X, Sepia 30X.

PURPOSE:

OTC - PURPOSE SECTION

Aconitum Napellus – Assists in Relieving Pain Associated with Cold Sores,† Adenoviren Nosode - Assists in Relieving Symptoms of Cold Sores,† Cytomegalovirus Nosode - Assists in Relieving Symptoms of Cold Sores,† Dulcamara - Assists in Relieving Symptoms of Cold Sores,† Epstein-Barr Virus Nosode - Assists in Relieving Symptoms of Cold Sores,† Fagopyrum Esculentum – Assists in Relieving the Pustules and Itching Associated with Cold Sores,† Glycyrrhiza Glabra - Assists in Relieving Symptoms of Cold Sores,† Herpes Simplex I and II Nosode - Assists in Relieving Symptoms of Cold Sores,† Herpes Zoster Nosode - Assists in Relieving Symptoms of Cold Sores,† Natrum Hypochlorosum – Assists in Relieving the Itching Associated with Cold Sores,† Natrum Muriaticum – Assists in Relieving Blistering, Dry Cracked Skin and Pustules Associated with Cold Sores,† Ranunculus Bulbosus – Assists in Relieving the Pain, Burning and Itching Associated with Cold Sores,† Rhus Tox – Assists in Relieving Blistering, Dry Cracked Skin and Pustules Associated with Cold Sores,† Sepia – Assists in Relieving Symptoms of Cold Sores.

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

Assists in relieving the symptoms of cold sores including

•blistering, •dry cracked skin, •pustules, and the •pain,

•burning, •itching associated with the same.†

†Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

If condition worsens, seek medical attention.

KEEP OUT OF REACH OF CHILDREN

Do not use if tamper evident seal is broken or missing.

Store in a cool place after opening

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• Adults: Acute 2 to 3 sprays orally every hour, up to 48 hours. Then 2 to 3 sprays three times per day. Chronic and maintenance 1 to 2 sprays       four times daily. Can be sprayed directly on afflicted areas in conjunction with oral use. Children under twelve one half adult dosage.

• Do not take within 15 minutes of consuming food, beverage or brushing teeth.

• Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Alcohol USP 20%, Purified Water USP.

QUESTIONS:

OTC - QUESTIONS SECTION

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Professional

Health Products

HOMEOPATHIC

NDC 83027-0007-1

COLD SORE 

FORMULA

2 FL. OZ (60 ml)

COLD SORE FORMULACOLD SORE FORMULA

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130649818030320GTIN-13: 0649818030320
EAN-13: 0649818030320
GTIN-12: 649818030320
UPC-A: 649818030320
GTIN storage (14 digits): 00649818030320
NSPC0014 Cold Sore Formula 9-6-24.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0007-1Cold Sore Formula60 mL in 1 BOTTLE, SPRAYSPRAY603

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83027-000783027-0007-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Sore FormulaDULCAMARA, 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 NOSODENutritional Specialties, Inc.f4e7e469-baaf-4c61-af44-80b0832eadf02026-03-31WarningsExact identifier
ndc (package): 83027-0007-1
ndc (product): 83027-0007
ndc11 (package): 83027000701
spl id: 3fa008ed-7e39-4a5e-a1eb-f76ffa523573
spl set id: f4e7e469-baaf-4c61-af44-80b0832eadf0

Reported adverse events (FAERS/openFDA)#

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