NDC 62106-1168-08 — UNDA 295 Pulsatilla, Nux vomica, Aloe

🆔 Identity & classification

FDA NDC (as labeled) 62106-1168-8

Product NDC 62106-1168

11-digit billing NDC 62106116808

UNII B4R1EZ1R1D, YF70189L0N, 1WZA4Y92EX, 8L72OKJ7II, W2FH8O2BBE, 6D74QW4H67 +12 more

SPL Set ID 079c945e-7853-3410-e054-00144ff88e88

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

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

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

DEA schedule Non-controlled

Marketing category UNAPPROVED HOMEOPATHIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2015-05-27

Route ORAL

Dosage form LIQUID

Substance STRYCHNOS NUX-VOMICA SEED; ALOE; PULSATILLA VULGARIS

Why two NDCs? The FDA registers this code as 62106-1168-8 — 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 → 62106-1168-08. 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

LabelerSeroyal USA

Labeler code62106

First marketedMay 2015

Product typeHuman Otc Drug

Portfolio129 products on file

🔎 All NDCs from Seroyal USA

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?

UNDA 295 is a homeopathic liquid taken by mouth containing pulsatilla, nux vomica, and aloe. In homeopathic practice, these plant extracts are traditionally used to address digestive complaints and related symptoms. Homeopathic products are marketed based on traditional homeopathic theory and are not evaluated by the FDA for effectiveness or safety.

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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 mL	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
Unda 295 4 [hp_X]/20mL; 6 [hp_X]/20mL; 4 [hp_X]/20mLthis 62106-1168-08	Seroyal	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

May 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
62106-1168-08 You're viewing this	1 BOTTLE, GLASS in 1 CARTON (62106-1168-8) / 20 mL in 1 BOTTLE, GLASS	2015-05-27	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

UNDA 295 Pulsatilla, Nux vomica, Aloe socotrina 4 [hp_X]/20mL; 6 [hp_X]/20mL; 4 [hp_X]/20mL LIQUID 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)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 62106-1168-8, 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: 62106-1168-08, written without dashes as 62106116808. 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 62106-1168-08, the first segment (62106) is the labeler code FDA assigned to Seroyal USA; the middle segment (1168) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 Seroyal USA. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Seroyal USA 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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage ~1 min read ▾

Uses For the temporary relief of symptoms associated with minor fever. Directions Adults and adolescents (12 years and older): Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years): Take under the direction of your healthcare practitioner.

Uses For the temporary relief of symptoms associated with occasional constipation and flatulence. Directions Adults and adolescents (12 years and older): Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years): Take under the direction of your healthcare practitioner.

Uses For the temporary relief of symptoms associated with minor stress and mental fatigue. Directions Adults and adolescents (12 years and older): Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years): Take under the direction of your healthcare practitioner.

Uses For the temporary relief of symptoms associated with mild indigestion. Directions Adults and adolescents (12 years and older): Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years): Take under the direction of your healthcare practitioner.

Uses For the temporary relief of symptoms associated with mild sleeplessness and nervousness. Directions Adults and adolescents (12 years and older): Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years): Take under the direction of your healthcare practitioner.

⏱️ Dosage and Administration 165 words ▾

Directions Adults and adolescents (12 years and older): Take 5 drops three times daily or as recommended by your healthcare practitioner. Children (under 12 years): Take under the direction of your healthcare practitioner.

⚠️ Warnings 215 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 75 words ▾

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

🧪 Active Ingredient 184 words ▾

Active ingredients Each drop contains: Argentum metallicum (Silver) 12X Asparagus officinalis (Asparagus) Shoot 4X Berberis vulgaris (Barberry) Bark 4X Genista tinctoria Aerial Parts 4X Juniperus communis (Common juniper) Berry 4X Petroselinum sativum (Parsley) Whole Plant 4X Rhamnus frangula (Buckthorn) Bark 4X Thlaspi bursa-pastoris (Shepherd’s purse) Aerial Parts 4X

Active ingredients Each drop contains: Argentum metallicum (Silver) 12X Carum carvi (Caraway) Fruit 4X Foeniculum vulgare (Fennel) Fruit 4X Illicium verum (Star anise) Fruit 4X Rhamnus cathartica (Purging buckthorn) Fruit 4X Rhamnus frangula (Alder buckthorn) Bark 4X Senna Leaflet 4X

Active ingredients Each drop contains: Aurum metallicum (Gold) 12X Melissa officinalis (Lemon balm) Leaf and Shoot 4X Mentha piperita Aerial Parts 4X Plumbum metallicum (Lead) 12X Salvia pratensis Leaf 4X Thymus vulgaris Aerial Parts 4X Valeriana officinalis (Valerian) Root 4X

Active ingredients Each drop contains: Aloe Inspissated juice 6X Nux vomica (Poison nut) Seed 4X (2.7 x 10-4 % alkaloids, calculated) Pulsatilla (Wind Flower) Whole Plant 4X

Active ingredients Each drop contains: Lactuca virosa (Poisonous lettuce) Whole Plant 6X Passiflora incarnata (Passion flower) Aerial Parts 6X Thymus vulgaris Aerial Parts 6X Valeriana officinalis (Valerian) Root 6X

🧪 Inactive Ingredients 30 words ▾

Inactive Ingredients: Ethanol (beet), purified water

Inactive ingredients Ethanol (beet), purified water

Inactive Ingredients: Ethanol (beet), purified water

🎯 Purpose 62 words ▾

Uses For the temporary relief of symptoms associated with minor fever.

Uses For the temporary relief of symptoms associated with occasional constipation and flatulence.

Uses For the temporary relief of symptoms associated with minor stress and mental fatigue.

Uses For the temporary relief of symptoms associated with mild indigestion.

Usea For the temporary relief of symptoms associated with mild sleeplessness and nervousness.

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

🔗 Related NDC lookups

🧪 All Pulsatilla, Nux Vomica, Aloe Socotrina NDCsSame ingredient 🏭 All Seroyal labeler NDCsLabeler code 62106 📚 All Non-Standardized Plant Allergenic Extract NDCsDrug class

UNDA 295 Pulsatilla, Nux vomica, Aloe socotrina 4 [hp_X]/20mL; 6 [hp_X]/20mL; 4 [hp_X]/20mL Liquid

🆔 Identity & classification

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

About homeopathic listings

Questions about this listing

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups