Home › NDC Lookup › Ingredients › Betaine - Bufo Bufo Cutaneous Gland - Ca... › 17089-0350-18
GUNA-AWARENESS BETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE 12 [hp_X]/30mL; 4 [hp_C]/30mL; 3 [hp_X]/30mL; 4 [hp_C]/30mL; 4 [hp_C]/30mL; 6 [hp_X]/30mL; 12 [hp_X]/30mL; 6 [hp_X]/30mL Solution/ Drops — NDC 17089-0350-18 package photo

GUNA-AWARENESS BETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE 12 [hp_X]/30mL; 4 [hp_C]/30mL; 3 [hp_X]/30mL; 4 [hp_C]/30mL; 4 [hp_C]/30mL; 6 [hp_X]/30mL; 12 [hp_X]/30mL; 6 [hp_X]/30mL Solution/ Drops

by Guna spa · 1 BOTTLE, DROPPER in 1 BOX (17089-350-18) / 30 mL in 1 BOTTLE, DROPPER
NDC 17089-0350-18
🏷️ FDA NDC (as labeled) 17089-350-18 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) 17089-350-18
Product NDC 17089-350
11-digit billing NDC 17089035018
UNII VSW71SS07I, JL5DK93RCL, 81AH48963U, 02R4V6T25Y, P658DCA9XD, 1JQS135EYN +12 more
UPC 0317089350187
SPL Set ID 10e46b39-7903-4390-b72d-865291245b4c
Established class (EPC) Oxytocic; Thyroid Stimulating Hormone; Methylating Agent; Standardized Chemical Allergen; Copper-containing Intrauterine Device
Mechanism of action Methylating Activity
Physiologic effect Increased Uterine Smooth Muscle Contraction or Tone; Increased Histamine Release; Cell-mediated Immunity; Decreased Embryonic Implantation; Decreased Sperm Motility; Inhibit Ovum Fertilization
Chemical class Oxytocin; Thyrotropin; Allergens; Copper
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-04-16
Route ORAL
Dosage form SOLUTION/ DROPS
Substance LACHESIS MUTA VENOM; MELATONIN; MOLYBDENUM; NEUROTROPHIN-3; NEUROTROPHIN-4; OXYTOCIN; SILICON DIOXIDE; SUS SCROFA TEMPORAL LOBE; THYROTROPIN ALFA; BETAINE; VANADIUM; ZINC; GOLD; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BUFO BUFO CUTANEOUS GLAND; CALCIUM C
Why two NDCs? The FDA registers this code as 17089-350-18 — 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 → 17089-0350-18. 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 marketedApr 2008
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-Awareness Betaine is an unapproved homeopathic oral solution containing multiple plant, mineral, and animal-derived substances. In homeopathic practice, these ingredients are traditionally used to support various functions, including cognitive and neurological activity (neurotrophin compounds, melatonin, cobalamin), tissue repair and metabolism (betaine, folic acid, iron, copper), and mineral balance (calcium carbonate, chromic sulfate, molybdenum, silicon dioxide). Homeopathic products are marketed based on homeopathic tradition and are not 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.

  • 9 mL / 30 mL 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.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesInactive ingredient: Ethyl alcohol 30%.

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-Awareness 12 [hp_X]/30mL; 4 [hp_C]/30mL; 3 [hp_X]/30mL; 4 [hp_C]/30mL; 4 [hp_C]/30mL; 6 [hp_X]/30mL; 12 [hp_X]/30mL; 6 [hp_X]/30mLthis 17089-0350-18 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

🏛️
2008
On the market since
Apr 2008
📍
2026
Currently FDA-listed
18 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
17089-0350-18 You're viewing this 1 BOTTLE, DROPPER in 1 BOX (17089-350-18) / 30 mL in 1 BOTTLE, DROPPER 2018-12-21 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

GUNA-AWARENESS BETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE 12 [hp_X]/30mL; 4 [hp_C]/30mL; 3 [hp_X]/30mL; 4 [hp_C]/30mL; 4 [hp_C]/30mL; 6 [hp_X]/30mL; 12 [hp_X]/30mL; 6 [hp_X]/30mL SOLUTION/ DROPS 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 17089-350-18, 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: 17089-0350-18, written without dashes as 17089035018. 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 17089-0350-18, the first segment (17089) is the labeler code FDA assigned to Guna spa; the middle segment (0350) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (18) 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 5 words ▾

Take 15 minutes before meals

⏱️ Dosage and Administration 49 words ▾

DIRECTIONS Take 15 minutes before meals Adults and children 12 years and older 20 drops in a little water, 2 times per day Children between 12 years and 6 years of age 10 drops in a little water, 2 times per day Children under 6 years consult a physician

⚠️ Warnings 51 words ▾

WARNINGS Stop use and ask doctor if symptoms persist more than 5 days or worsen. 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 30%

🧪 Active Ingredient 138 words ▾

ACTIVE INGREDIENTS/PURPOSE AURUM METALLICUM 12X Supports mood and emotional balance BRAIN DERIVED NEUROTROPHIC FACTOR 4C Neurotrophic support BUFO RANA 12X Relieves irritability CALCAREA CARBONICA 3X Antioxidant CHROMIUM SULPHURICUM 3X Antioxidant CICUTA VIROSA 12X Relieves irritability COBALAMIN 3X Antioxidant COENZYME Q 3X Supports nervous system function CUPRUM METALLICUM 12X Relieves irritability FERRUM METALLICUM 3X Relieves metal exhaustion FOLIC ACID 3X Supports nervous system function FRONTAL LOBE 6X Supports brain function LACHESIS MUTUS 12X Supports mood and emotional balance MELATONIN 4C Helps relaxation MOLYBDENUM METALLICUM 3X Antioxidant NEUROTROPHIN 3 4C SUPPORTS Neurotrophic support NEUROTROPHIN 4 4C SUPPORTS Neurotrophic support OXYTOCIN 6X Supports mood and emotional balance SILICEA 12X Relieves mental exhaustion TEMPORAL LOBE 6X Supports brain function THYROTROPIN-RELEASING HORMONE 3X Neurotrophic support TRIMETHYLGLYCINE 3X Supports nerbous system function VANADIUM METALLICUM 6X Supports brain function ZINCUM METALLICUM 3X Supports brain function

🧪 Inactive Ingredients 6 words ▾

Inactive ingredient : Ethyl alcohol 30%.

🎯 Purpose 17 words ▾

USES Supports mental and emotional balance, useful in cases of: • Difficulty concentrating • Restlessness • Irritability

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 17089-0349-18 · Guna 17089-0370-18 · 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.