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Simplex Passiflora incarnata, Ignatia Amara, Valeriana Officinalis 3 [hp_X]/1; 3 [hp_X]/1; 3 [hp_X]/1 Tablet, 6-count

by Nartex Laboratories · 6 TABLET in 1 BOX (34666-008-06)
NDC 34666-0008-06
🏷️ FDA NDC (as labeled) 34666-008-06 billing pads the product segment with a zero
This package
Contains6-count Pack sizes2 compare ↓
Also comes in: 60 tablets 34666-0008-60
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) 34666-008-06
Product NDC 34666-008
11-digit billing NDC 34666000806
UNII K8F3G29S6Z, 1NM3M2487K, JWF5YAW3QW
SPL Set ID d9047378-5d03-4ef5-98f9-3eb78840222c
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-12-23
Route ORAL
Dosage form TABLET
Substance PASSIFLORA INCARNATA FLOWER; STRYCHNOS IGNATII SEED; VALERIAN
Why two NDCs? The FDA registers this code as 34666-008-06 — 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 → 34666-0008-06. 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

LabelerNartex Laboratories
Labeler code34666
First marketedDec 2010
Product typeHuman Otc Drug
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?

Simplex is an unapproved homeopathic oral tablet containing three plant-derived ingredients: passionflower, ignatia (a seed extract), and valerian root. In homeopathic practice, these ingredients are traditionally used to address nervous tension and sleep concerns. Homeopathic products are marketed based on traditional use rather than being evaluated by the FDA for 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 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 8I089SAH3T
    A carbohydrate powder extracted from potatoes. It serves as a filler to add bulk and volume to the tablet or capsule, and as a disintegrant to help the medicine break apart and release its active ingredient in your body.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesGelatin, Lactose USP, Magnesium Stearate, Potato Starch, Purified water, Sodium Benzoate, Talc USP

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 eachPer 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.
Try another pack size: 60 tablets
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
Simplex 3 [hp_X]/1; 3 [hp_X]/1; 3 [hp_X]this 34666-0008-06 Nartex 6 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

🏛️
2010
On the market since
Dec 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.

🔬 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 Simplex (this brand).

Top reported reactions

Fatigue3
Nausea3
Condition Aggravated2
Cough2
Dyspnoea2
Feeling Abnormal2
Feeling Jittery2

Age at onset

Elderly1

Reporter sex

12 reports
Male · 50%
Female · 50%

Serious outcomes

Hospitalization6
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2025 2026 1 0
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 NDCDescription Marketing startStatus
34666-0008-06 You're viewing this 6 TABLET in 1 BOX (34666-008-06) 2010-12-23 Active
34666-0008-60 60 TABLET in 1 BOX (34666-008-60) 2010-12-23 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 34666-0008-06?
NDC 34666-0008-06 is a 6-count package — 6 tablet in 1 box.
What is the difference between NDC 34666-0008-06 and NDC 34666-0008-60?
Both are Simplex Passiflora incarnata, Ignatia Amara, Valeriana Officinalis 3 [hp_X]/1; 3 [hp_X]/1; 3 [hp_X]/1 Tablet — the drug itself is identical. NDC 34666-0008-06 is the 6-count package, while NDC 34666-0008-60 is the 60 tablets package.
What NDC number is used to bill for this package of Simplex Passiflora incarnata, Ignatia Amara, Valeriana Officinalis 3 [hp_X]/1; 3 [hp_X]/1; 3 [hp_X]/1 Tablet?
Bill NDC 34666-0008-06 — the 11-digit billing format is 34666000806. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Simplex Passiflora incarnata, Ignatia Amara, Valeriana Officinalis 3 [hp_X]/1; 3 [hp_X]/1; 3 [hp_X]/1 TABLET 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) ✓ 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 34666-008-06, 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: 34666-0008-06, written without dashes as 34666000806. 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 34666-0008-06, the first segment (34666) is the labeler code FDA assigned to Nartex Laboratories; the middle segment (0008) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) 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 Nartex Laboratories. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 60 tablets (34666-0008-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Nartex Laboratories 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 38 words ▾

For relief of symptoms of sleeplessness and stress as per homeopathic materia medica. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and poduct has not been clinically tested.

⏱️ Dosage and Administration 27 words ▾

Directions: Adults and children over 12 years: take 2 tablets every 4 hours during the day. Dissolve slowly in the mouth. Children under 12: Do not use.

⚠️ Warnings 15 words ▾

Do not use if you have an allergy or hypersensitivity to components of the formula

📦 Storage and Handling 7 words ▾

store in a cool and dry place

🧪 Active Ingredient 12 words ▾

Ignatia amara 3X HPUS Passiflora incarnata 3X HPUS Valeriana officinalis 3X HPUS

🧪 Inactive Ingredients 13 words ▾

Gelatin, Lactose USP, Magnesium Stearate, Potato Starch, Purified water, Sodium Benzoate, Talc USP

🎯 Purpose 14 words ▾

Ignatia Amara 3X HPUS.....................Sleeplessnes, worry Passiflora incarnata 3X HPUS.............Nervousness, sleeplessness Valeriana oficinalis 3X HPUS..............Sleeplessness

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 34666-0007-16 · NARTEX 34666-0010-12 · NARTEX →
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.