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AZZURX MELISSA OFFICINALIS LEAF,THUJA OCCIDENTALIS LEAF,GERANIUM MACULATUM,CALENDULA OFFICINALlS 3 [hp_X]/.5mL; 3 [hp_X]/.5mL; 3 [hp_X]/.5mL; 3 [hp_X]/.5mL Liquid, 3 applicators — NDC 83243-0001-01 package photo

AZZURX MELISSA OFFICINALIS LEAF,THUJA OCCIDENTALIS LEAF,GERANIUM MACULATUM,CALENDULA OFFICINALlS 3 [hp_X]/.5mL; 3 [hp_X]/.5mL; 3 [hp_X]/.5mL; 3 [hp_X]/.5mL Liquid, 3 applicators

by Outbreaks, Inc. · 3 APPLICATOR in 1 PACKAGE (83243-001-01) / .5 mL in 1 APPLICATOR
NDC 83243-0001-01
🏷️ FDA NDC (as labeled) 83243-001-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 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) 83243-001-01
Product NDC 83243-001
11-digit billing NDC 83243000101
UNII 50D2ZE9219, 0T0DQN8786, 93IXI5B6OJ, P0M7O4Y7YD
SPL Set ID 9e48aaac-48c2-451d-9f6f-369e65c1c52b
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-02-13
Route TOPICAL
Dosage form LIQUID
Substance MELISSA OFFICINALIS LEAF; THUJA OCCIDENTALIS LEAF; GERANIUM MACULATUM ROOT; CALENDULA OFFICINALIS FLOWER
Why two NDCs? The FDA registers this code as 83243-001-01 — a 5-3-2 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 product segment → 83243-0001-01. 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

LabelerOutbreaks, Inc.
Labeler code83243
First marketedFeb 2023
Product typeHuman Otc Drug
Portfolio2 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?

Azzurx is a topical liquid homeopathic product containing melissa officinalis (lemon balm) leaf, thuja occidentalis (arborvitae) leaf, geranium maculatum (wild geranium) root, and calendula officinalis (marigold) flower. In homeopathic practice, these plant materials are traditionally prepared and used for topical application. Homeopathic products are marketed based on traditional use and homeopathic theory; they are not evaluated by the FDA for effectiveness or safety. This product is an unapproved homeopathic drug.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 60F80Z61A9
    A fragrant plant oil extracted from chamomile flowers. It's used as a flavoring agent and fragrance in medicines to improve taste and smell, making the product more pleasant to take.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.

5 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesFractionated coconut oil, essential oil blend of chamomile, lavender, eucalyptus, and peppermint

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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
Azzurx 3 [hp_X]/.5mL; 3 [hp_X]/.5mL; 3 [hp_X]/.5mL; 3 [hp_X]/.5mLthis 83243-0001-01 Outbreaks, 3 applicators — — 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
Feb 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
83243-0001-01 You're viewing this 3 APPLICATOR in 1 PACKAGE (83243-001-01) / .5 mL in 1 APPLICATOR 2023-02-13 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

AZZURX MELISSA OFFICINALIS LEAF,THUJA OCCIDENTALIS LEAF,GERANIUM MACULATUM,CALENDULA OFFICINALlS 3 [hp_X]/.5mL; 3 [hp_X]/.5mL; 3 [hp_X]/.5mL; 3 [hp_X]/.5mL LIQUID 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 ✓ Available
Inactive ingredients (structured) ✓ 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 83243-001-01, 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: 83243-0001-01, written without dashes as 83243000101. 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 83243-0001-01, the first segment (83243) is the labeler code FDA assigned to Outbreaks, Inc.; the middle segment (0001) 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: this package is listed as actively marketed, with no marketing end date reported by Outbreaks, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Outbreaks, 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
🎯 Indications and Usage 9 words ▾

Uses For treatment of cold sores and fever blisters.

⏱️ Dosage and Administration 127 words ▾

Directions Application instructions Remove and reverse cardboard sleeve on applicator to expose swab. Crush applicator to activate by squeezing on the “X” (in AZZURX) between thumb and forefinger until you hear a snap. Rotate applicator with swab pointing downward and squeeze gently until the swab is saturated.

Discard after use. At the first sign of cold sore/fever blister (tingle) : Clean the area of the tingle before applying. Apply directly to face or lips at the site of the tingle.

Repeat every 12 hours until all applicators are used. After cold sore/fever blister erupts (skin broken): Clean the area of the outbreak before applying. Apply directly to the affected area of the face or lips.

Repeat every 24 hours as needed Children under 12: Ask a doctor

⚠️ Warnings 158 words ▾

Warnings For external use only. Flammable, keep away from fire or flame. Do not use if you are allergic to any ingredient in this product over large areas of the body When using this product apply only to affected area do not use in or near eyes avoid applying directly inside the mouth you may feel a brief burning sensation when you apply it.

It should go away in a short time. do not share or reuse an applicator, as spreading or reinfection may occur. do not remove cardboard sleeve after crushing,as cuts from glass may occur. Stop use and ask a doctor if – the cold sore worsens or the cold sore lasts for more than 7 days, or condition clears up and occurs again within a few days Ask a doctor if – you are pregnant or nursing Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center.

🧪 Active Ingredient 25 words ▾

Active ingredients Purpose Lemon Balm 3X HPUS Antiviral White Cedar 3X HPUS Anti-itch, Pain Reliever Spotted Geranium 3X HPUS Antiseptic Pot Marigold 3X HPUS Healing

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients Fractionated coconut oil, essential oil blend of chamomile, lavender, eucalyptus, and peppermint

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83241-1039-02 · Balmere 83243-0002-01 · Outbreaks, →
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.