NDC 69676-0010-01 — Flu Fix Aconitum napellus, Allium cepa, Anis

🆔 Identity & classification

FDA NDC (as labeled) 69676-0010-1

Product NDC 69676-0010

11-digit billing NDC 69676001001

UNII 269XH13919, 1W0775VX6E, 639KR60Q1Q, 8E272251DI, 46PYZ1F82M, 492225Q21H +6 more

SPL Set ID 7900b6f2-a563-831c-e053-2a91aa0a558d

Established class (EPC) Non-Standardized Plant Allergenic Extract; Non-Standardized Food Allergenic Extract

Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production

Chemical class Allergens; Plant Proteins; Seed Storage Proteins; Dietary Proteins; Vegetable Proteins

DEA schedule Non-controlled

Marketing category UNAPPROVED HOMEOPATHIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2018-07-11

Route ORAL

Dosage form TABLET, CHEWABLE

Substance STRYCHNOS NUX-VOMICA SEED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA PRATENSIS; TOXICODENDRON PUBESCENS SHOOT; ONION; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; ACONITUM NAPELLUS; EUPHRASIA STRICTA; CAIRINA MOSCHATA HEA

Why two NDCs? The FDA registers this code as 69676-0010-1 — 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 → 69676-0010-01. 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

LabelerGenexa Inc.

Labeler code69676

First marketedJul 2018

Product typeHuman Otc Drug

Portfolio40 products on file

🔎 All NDCs from Genexa Inc.

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?

Flu Fix is a chewable tablet taken by mouth marketed as a homeopathic product. It contains multiple plant and animal derived ingredients that are used in homeopathic practice, such as aconitum, bryonia, echinacea, eupatorium, gelsemium, and ipecac, which are traditionally chosen for symptoms resembling cold and flu. Homeopathic products are based on historical use and homeopathic principles rather than FDA evaluation for safety or effectiveness. This product is not approved by the FDA.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💊 What it looks like

Color white

ShapeRound

ImprintG

Size1 mm

ScoringNot scored

FlavorBerry

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 46AM2VJ0AW
A dried fruit powder from the acai berry, used as a natural colorant and flavor ingredient to add purple-red color and fruity taste to medicines and supplements.
UNII R12CBM0EIZ
A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
UNII IY9XDZ35W2
Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
UNII 7CVR7L4A2D
A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
UNII R60QEP13IC
Rice bran is a natural powder made from the outer layer of rice grains. It's used in medicines as a filler and flow agent to add bulk and help the product mix and flow smoothly during manufacturing.

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

The official label also statesInactive ingredients carnauba wax (organic), dextrose (organic), açaÍ berry flavor (organic), maltodextrin (organic), rice bran extract (organic)

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 system	Per each	Per 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Flu Fix 12 [hp_X]/1; 6 [hp_X]/1; 12 [hp_X]/1; 9 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1; 9 [hp_X]this 69676-0010-01	Genexa	60 tablets	—	—	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

🏛️

2018

On the market since

Jul 2018

📍

2026

Currently FDA-listed

8 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Aconitum napellus, Allium cepa, Anis barbariae, Bryonia alba, Echinacea angustifolia, Eupatorium perfollatum, Gelsemium sempervirens, Ipecacauanha, Nux vomica, Pulsatilla, Rhus toxicodendron — the ingredient across all brands.

Top reported reactions

Infection1

Reporter sex

Male · 100%

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
69676-0010-01 You're viewing this	1 BOTTLE, PLASTIC in 1 CARTON (69676-0010-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC	2018-07-11	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Flu Fix Aconitum napellus, Allium cepa, Anis barbariae, Bryonia alba, Echinacea angustifolia, Eupatorium perfollatum, Gelsemium sempervirens, Ipecacauanha, Nux vomica, Pulsatilla, Rhus toxicodendron 12 [hp_X]/1; 6 [hp_X]/1; 12 [hp_X]/1; 9 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1; 9 [hp_X]/1 TABLET, CHEWABLE 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 69676-0010-1, 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: 69676-0010-01, written without dashes as 69676001001. 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 69676-0010-01, the first segment (69676) is the labeler code FDA assigned to Genexa Inc.; the middle segment (0010) 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 Genexa Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Genexa 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 17 words ▾

Uses* addresses symptoms associated with the flu, such as: body aches headache chills fatigue congestion sore throat

⏱️ Dosage and Administration 52 words ▾

Directions take dose at the onset of symptoms chew tablets before swallowing; do not swallow whole repeat dose every 4-6 hours as needed adults and children 12 years of age & older 2 tablets children 4-11 years of age 1 tablet children under 4 years of age ask a doctor before use

⚠️ Warnings 45 words ▾

Warnings Stop use and ask a doctor if difficulty breathing, vomiting, skin rash, diarrhea or fever above 100°F (38°C) develops symptoms persist for more than 2 days or worsen. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

📦 Storage and Handling 14 words ▾

Other information store between 20-25°C (68-77°F) in a dry place out of direct sunlight

🧪 Active Ingredient 64 words ▾

Active ingredients** Aconitum napellus 12X HPUS Allium cepa 6X HPUS Anas barbariae 6C HPUS Bryonia alba 9X HPUS Echinacea angustifolia 6X HPUS Eupatorium perfoliatum 6X HPUS Euphrasia officinalis 6X HPUS Gelsemium sempervirens 12X HPUS Ipecacuanha 12X HPUS Nux vomica 12X HPUS Pulsatilla 9X HPUS Rhus toxicodendron 12X HPUS "HPUS" indicates that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients carnauba wax (organic), dextrose (organic), açaÍ berry flavor (organic), maltodextrin (organic), rice bran extract (organic)

🎯 Purpose 41 words ▾

Purpose* dry cough and wet cough sneezing and runny nose flu symptoms sinus pain, chills and fatigue sore throat and dry throat restless sleep chest congestion headache loss of smell nasal congestion mucus and loss of taste fever and body aches

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Aconitum Napellus, Allium Cepa, Anis Barbariae, Bryonia Alba, Echinacea Angustifolia, Eupatorium Perfollatum, Gelsemium Sempervirens, Ipecacauanha, Nux Vomica, Pulsatilla, Rhus Toxicodendron NDCsSame ingredient 🏭 All Genexa labeler NDCsLabeler code 69676