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GUNA-ORAL ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - SUS SCROFA TOOTH - WITCH HAZEL 3 [hp_X]/30mL; 3 [hp_X]/30mL; 4 [hp_X]/30mL; 2 [hp_X]/30mL; 2 [hp_X]/30mL; 2 [hp_X]/30mL; 6 [hp_X]/30mL; 3 [hp_X] Spray — NDC 17089-0452-27 package photo

GUNA-ORAL ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - SUS SCROFA TOOTH - WITCH HAZEL 3 [hp_X]/30mL; 3 [hp_X]/30mL; 4 [hp_X]/30mL; 2 [hp_X]/30mL; 2 [hp_X]/30mL; 2 [hp_X]/30mL; 6 [hp_X]/30mL; 3 [hp_X] Spray

by Guna spa · 1 BOTTLE, SPRAY in 1 BOX (17089-452-27) / 50 mL in 1 BOTTLE, SPRAY
NDC 17089-0452-27
🏷️ FDA NDC (as labeled) 17089-452-27 billing pads the product 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) 17089-452-27
Product NDC 17089-452
11-digit billing NDC 17089045227
UNII U0NQ8555JD, O80TY208ZW, WQZ3G9PF0H, VB06AV5US8, QI7G114Y98, 101I4J0U34 +5 more
UPC 0317089452270
SPL Set ID f1b8e5ab-8689-4bf2-a6d9-863d02f29579
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-05-27
Route ORAL
Dosage form SPRAY
Substance ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; WITCH HAZEL; CALCIUM SULFIDE; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; COMFREY ROOT; SUS SCROFA TOOTH
Why two NDCs? The FDA registers this code as 17089-452-27 — 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 → 17089-0452-27. 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

LabelerGuna spa
Labeler code17089
First marketedMay 2010
Product typeHuman Otc Drug
Portfolio83 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?

Guna-Oral is an unapproved homeopathic spray taken by mouth that contains a mixture of plant and mineral ingredients. These ingredients, including arnica, echinacea, hypericum, witch hazel, comfrey root, and others, are traditionally used in homeopathic practice for various purposes such as supporting the immune system and promoting general wellness. Homeopathic products are marketed based on homeopathic theories and traditions, not on scientific evidence evaluated by the FDA for safety or effectiveness.

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 9H7TY1ZV7Q
    A natural oil extracted from Sakhalin spruce tree needles. Used as a fragrance and flavoring agent to add pleasant scent and taste to the medicine.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII I9GRO824LL
    Lemon oil is a natural fragrant extract from lemon peel. It's used in medicines as a flavoring agent to mask unpleasant tastes and improve how the medicine tastes to patients.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.

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

The official label also statesInactive ingredients: Essential oil of lemon, Essential oil of pine, Ethyl alcohol 20%, Polysorbate-80.

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
Guna-Oral 3 [hp_X]/30mL; 3 [hp_X]/30mL; 4 [hp_X]/30mL; 2 [hp_X]/30mL; 2 [hp_X]/30mL; 2 [hp_X]/30mL; 6 [hp_X]/30mL; 3 [hp_X]this 17089-0452-27 Guna 1 bottle — — 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

🏛️
2010
On the market since
May 2010
📍
2026
Currently FDA-listed
16 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
17089-0452-27 You're viewing this 1 BOTTLE, SPRAY in 1 BOX (17089-452-27) / 50 mL in 1 BOTTLE, SPRAY 2018-12-21 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

GUNA-ORAL ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - SUS SCROFA TOOTH - WITCH HAZEL 3 [hp_X]/30mL; 3 [hp_X]/30mL; 4 [hp_X]/30mL; 2 [hp_X]/30mL; 2 [hp_X]/30mL; 2 [hp_X]/30mL; 6 [hp_X]/30mL; 3 [hp_X] 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 ✓ 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 17089-452-27, 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: 17089-0452-27, written without dashes as 17089045227. 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 17089-0452-27, the first segment (17089) is the labeler code FDA assigned to Guna spa; the middle segment (0452) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (27) 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 Guna spa. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guna spa 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 19 words ▾

Directions : Rotate the nebulizer to the upright position. Spray onto affected areas: mouth, throat or gingiva as needed.

⏱️ Dosage and Administration 37 words ▾

DIRECTIONS Adults and children 12 years and older 2 sprays, 3-5 times per day Children between 12 years and 6 years of age 1 spray t, 3-5 times per day Children under 6 years ask a doctor

⚠️ Warnings 48 words ▾

WARNINGS Stop use and ask doctor if symptoms persist more than 3 days. If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Contains ethyl alcohol 20%

🧪 Active Ingredient 56 words ▾

ACTIVE INGREDIENTS/PURPOSE ACONITUM NAPELLUS 3X ANTI-INFLAMMATORY ARNICA MONTANA 3X FEVER RELIEF BELLADONNA 4X SWELLING ECHINACEA ANGUSTIFOLIA 2X BACTERIAL INFECTION ECHINACEA PURPUREA 2X IMMUNE SUPPORT HAMAMELIS VIRGINIANA 2X SUPPORTS TISSUE REPAIR HEPAR SULFURIS CALCAREUM 6X ANTIBACTERIAL IMMUNE SUPPORT HYPERICUM PERFORATUM 3X PAIN RELIEF MILLEFOLIUM 3X ORAL ANTI- INFLAMMATORY SYMPHYTUM OFFICINALE 6X ORAL HYPERSENSITIVITY TEETH 12X TOOTH HYPERSENSITIVITY

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients : Essential oil of lemon, Essential oil of pine, Ethyl alcohol 20%, Polysorbate-80.

🎯 Purpose 19 words ▾

USES Temporary relief of symptoms due to inflammation of the oral cavity such as: Sore throat Inflamed gums Pharyngitis

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 17089-0451-23 · Guna 17089-0453-24 · Guna →
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.