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PASSIFLORA PLEX Passiflora incarnata, Ignatia amara, Jalapa, Coffea cruda, Magnesium metalicum, Palladium metallicum, Tellurium metallicum, Phosphoricum acidum 3 [hp_X]/30mL; 10 [hp_X]/30mL; 10 [hp_X]/30mL; 8 [hp_X]/30mL; 8 [hp_X]/30mL; 10 [hp_X]/30mL; 10 [hp_X]/30mL; 14 Liquid — NDC 52503-1322-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PASSIFLORA PLEX Passiflora incarnata, Ignatia amara, Jalapa, Coffea cruda, Magnesium metalicum, Palladium metallicum, Tellurium metallicum, Phosphoricum acidum 3 [hp_X]/30mL; 10 [hp_X]/30mL; 10 [hp_X]/30mL; 8 [hp_X]/30mL; 8 [hp_X]/30mL; 10 [hp_X]/30mL; 10 [hp_X]/30mL; 14 Liquid — NDC 52503-1322-0 (Billing 52503-1322-00)

by SanUp · 1 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS

This is a package of PASSIFLORA PLEX Passiflora incarnata, Ignatia amara, Jalapa, Coffea cruda, Magnesium metalicum, Palladium metallicum, Tellurium metallicum, Phosphoricum acidum 3 [hp_X]/30mL; 10 [hp_X]/30mL; 10 [hp_X]/30mL; 8 [hp_X]/30mL; 8 [hp_X]/30mL; 10 [hp_X]/30mL; 10 [hp_X]/30mL; 14 Liquid from SanUp, marketed since Feb 2015 and currently FDA-listed. It is this product's only package size.

NDC 52503-1322-00
🏷️ FDA NDC (as labeled) 52503-1322-0 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 52503-1322-0 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
52503 labeler · 1322 product · 0 package
Package marketed since
Feb 9, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0883196325306
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 52503-1322-0
Product NDC 52503-1322
11-digit billing NDC 52503132200
UNII CLF5YFS11O, 3SW678MX72, I38ZP9992A, 1NM3M2487K, 4UDO46YBK2, 5TWQ1V240M +2 more
UPC 0883196325306
SPL Set ID 937b6700-3ba8-0266-e053-2995a90a3318
Established class (EPC) Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens; Dietary Proteins; Plant Proteins; Seed Storage Proteins
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-02-09
Route SUBLINGUAL
Dosage form LIQUID
Substance PASSIFLORA INCARNATA FLOWERING TOP; ARABICA COFFEE BEAN; MAGNESIUM; STRYCHNOS IGNATII SEED; IPOMOEA PURGA ROOT; PALLADIUM; TELLURIUM; PHOSPHORIC ACID
Why two NDCs? The FDA registers this code as 52503-1322-0 — 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 → 52503-1322-00. 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.

Clinical

🧪 What is this product?

Passiflora Plex is a sublingual liquid product containing plant and mineral ingredients marketed as an unapproved drug. The formula includes passiflora incarnata (passionflower), which is commonly used in herbal preparations for relaxation, as well as ignatia amara (St. Ignatius bean), coffee bean extract, and jalapa root, each of which appear in traditional herbal and homeopathic formulations. The product also contains metallic and mineral components including magnesium, palladium, tellurium, and phosphoric acid, which are used in homeopathic preparations.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
52503-1322-00 You're viewing this Main listing 1 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS 2015-02-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Passiflora Plex 3 [hp_X]/30mL; 10 [hp_X]/30mL; 10 [hp_X]/30mL; 8 [hp_X]/30mL; 8 [hp_X]/30mL; 10 [hp_X]/30mL; 10 [hp_X]/30mL; 14this 52503-1322-00 SanUp 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

🏛️
2015
On the market since
Feb 2015
📍
2026
Currently FDA-listed
11 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.

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.

  • 14.94 g / 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.
  • 12.07 g / 30 mL 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.

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

The official label also statesInactive ingredients Ethanol (beet), purified water

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.

Manufacturer & labeler

LabelerSanUp
Labeler code52503
First marketedFeb 2015
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.

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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 137 words ▾

Uses For the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness. Product ‘Uses’ are based on Homeopathic Materia Medica and are not supported by clinical trials. These 'Uses' have not been evaluated by the Food and Drug Administration.

Directions To be taken 10 minutes away from food. Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water. Hold contents for about 20 seconds and swallow.

To promote drop flow, invert bottle and shake before each use. Dosage frequency may be increased up to 6 times daily depending on the severity of symptoms. Adults and adolescents (12 years and older) Take 10 drops 3 times daily or as recommended by your healthcare practitioner.

Children (under 12 years) .Take under the direction of your healthcare practitioner.

⏱️ Dosage and Administration 95 words ▾

Directions To be taken 10 minutes away from food. Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water. Hold contents for about 20 seconds and swallow.

To promote drop flow, invert bottle and shake before each use. Dosage frequency may be increased up to 6 times daily depending on the severity of symptoms. Adults and adolescents (12 years and older) Take 10 drops 3 times daily or as recommended by your healthcare practitioner.

Children (under 12 years) .Take under the direction of your healthcare practitioner.

⚠️ Warnings 43 words ▾

Warnings Stop use and ask a doctor if symptoms persist or worsen. If pregnant or breastfeeding, 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.

🆘 Overdosage 15 words ▾

In case of overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 46 words ▾

Active ingredients Each drop contains: Coffea cruda (Coffee) Unroasted Seed 10X Ignatia amara (St. Ignatius’ bean) Seed 8X Jalapa (Jalap) Tuber 8X Magnesium metallicum (Magnesium) 10X Passiflora incarnata (Passion flower) Aerial Parts 3X Phosphoricum acidum (Phosphoric acid) 14X Palladium metallicum (Palladium) 10X Tellurium metallicum (Tellurium) 10X

🧪 Inactive Ingredients 6 words ▾

Inactive ingredients Ethanol (beet), purified water

🎯 Purpose 15 words ▾

Uses For the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness.

📄 Stop Use and Ask a Doctor If 11 words ▾

Stop use and ask a doctor if symptoms persist or worsen.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breastfeeding, ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Other Information 31 words ▾

Do not use if seal is missing or broken. Store in a cool, dry place. Contents may not fill package in order to accommodate required labeling. Please rely on stated quantity.

📄 Recent Major Changes 33 words ▾

Indications & Usage section Addition of: "Product ‘Uses’ are based on Homeopathic Materia Medica and are not supported by clinical trials. These 'Uses' have not been evaluated by the Food and Drug Administration."

📄 Package Label / Principal Display Panel 32 words ▾

NDC 62106-1322-0 UNDA PLEX PASSIFLORA PLEX Homeopathic Preparation For the temporary relief of symptoms associated with irregular sleep patterns and ordinary restlessness. Contains 60% Alcohol 30 mL (1 fl oz) Passiflora plex.jpg

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

About this NDC listing & data coverage

Over-the-counter (OTC) product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 Drug Other". 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 SanUp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SanUp 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.
← 52494-0100-25 · Method 52536-0004-03 · Wilshire →
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.