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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, Ad 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 5 [hp_X]/mL; 6 [hp_X]/mL; 8 [hp_X]/mL; 12 [hp_X]/mL Spray, 60 mL

by Nutritional Specialties, Inc. · 60 mL in 1 BOTTLE, SPRAY (83027-0007-1)
NDC 83027-0007-01
🏷️ FDA NDC (as labeled) 83027-0007-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 83027-0007-1
Product NDC 83027-0007
11-digit billing NDC 83027000701
UNII KPS1B1162N, 2788Z9758H, AEQ8NXJ0MB, 6IO182RP7A, 451W47IQ8X, B10M69172N +9 more
UPC 0649818030320
SPL Set ID f4e7e469-baaf-4c61-af44-80b0832eadf0
Established class (EPC) Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens; Dietary Proteins; Plant Proteins
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-03-30
Marketing end 2029-10-25
Route ORAL
Dosage form SPRAY
Substance SOLANUM 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; S
Why two NDCs? The FDA registers this code as 83027-0007-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 83027-0007-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerNutritional Specialties, Inc.
Labeler code83027
First marketedMar 2023
Product typeHuman Otc Drug
Portfolio162 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is an unapproved homeopathic oral spray marketed for cold sore symptoms. Homeopathic products are based on traditional homeopathic practice and are not evaluated by the FDA for effectiveness or safety. The formula contains diluted plant extracts, minerals, and viral antigens that are used in homeopathic tradition to address symptoms associated with herpes simplex and related viral infections. Homeopathic remedies rely on established homeopathic principles rather than conventional medical evidence.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cold Sore Formula 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 5 [hp_X]/mL; 6 [hp_X]/mL; 8 [hp_X]/mL; 12 [hp_X]/mLthis 83027-0007-01 Nutritional 60 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
83027-0007-01 You're viewing this 60 mL in 1 BOTTLE, SPRAY (83027-0007-1) 2023-03-30 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

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, Ad 3 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 5 [hp_X]/mL; 6 [hp_X]/mL; 8 [hp_X]/mL; 12 [hp_X]/mL SPRAY is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Homeopathic". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 83027-0007-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 83027-0007-01, written without dashes as 83027000701. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 83027-0007-01, the first segment (83027) is the labeler code FDA assigned to Nutritional Specialties, Inc.; the middle segment (0007) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but Nutritional Specialties, Inc. has reported a marketing end date of 2029-10-25, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Nutritional Specialties, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 37 words ▾

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 80 words ▾

DIRECTIONS: • 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.

⚠️ Warnings 56 words ▾

WARNINGS: 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

🧪 Active Ingredient 70 words ▾

ACTIVE INGREDIENTS: (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.

🧪 Inactive Ingredients 8 words ▾

INACTIVE INGREDIENTS: Alcohol USP 20%, Purified Water USP.

🎯 Purpose 182 words ▾

PURPOSE: 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83027-0006-01 · Nutritional 83027-0008-01 · Nutritional →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.