Home › NDC Lookup › Ingredients › Polygonatum Cepa › 48951-8310-05
🧴image loading
(from DailyMed)

Polygonatum Cepa 2 [hp_X]/g; 2 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 6 [hp_X]/g; 8 [hp_X]/g; 8 [hp_X]/g; 8 [hp_X]/g; 8 [hp_X]/g; 8 Gel, 60 g

by Uriel Pharmacy Inc. · 60 g in 1 TUBE (48951-8310-5)
NDC 48951-8310-05
🏷️ FDA NDC (as labeled) 48951-8310-5 billing pads the package 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) 48951-8310-5
Product NDC 48951-8310
11-digit billing NDC 48951831005
UNII 492225Q21H, VB06AV5US8, MNY7X23SRZ, W93B56AH6R, K3ALM8S49H, 79Y1949PYO +9 more
SPL Set ID 6ba0ac36-16cc-49bd-b37f-90cf18acbd5a
Established class (EPC) Non-Standardized Food Allergenic Extract; Standardized Chemical Allergen; Copper-containing Intrauterine Device; Non-Standardized Animal Skin Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Decreased Embryonic Implantation; Decreased Sperm Motility; Inhibit Ovum Fertilization; Increased IgG Production
Chemical class Allergens; Dietary Proteins; Vegetable Proteins; Copper
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-09-01
Route TOPICAL
Dosage form GEL
Substance ONION; ECHINACEA ANGUSTIFOLIA; HIRUDIN; POLYGONATUM CYRTONEMA ROOT; VESPA CRABRO; GOLD; BOS TAURUS CARTILAGE; COPPER; SUS SCROFA SKIN; BOS TAURUS PLACENTA; SILICON DIOXIDE; THUJA OCCIDENTALIS WHOLE; SILVER; BARIUM CITRATE; GRAPHITE
Why two NDCs? The FDA registers this code as 48951-8310-5 — 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 → 48951-8310-05. 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

LabelerUriel Pharmacy Inc.
Labeler code48951
First marketedSep 2009
Product typeHuman Otc Drug
Portfolio203 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?

This is an unapproved homeopathic topical gel containing multiple plant, animal, and mineral substances. In homeopathic practice, ingredients like echinacea, onion, and thuja are traditionally used for immune and skin support, while substances such as gold, copper, and silver are used in homeopathic formulations for various purposes based on homeopathic theory. Homeopathic products are marketed based on traditional use and homeopathic principles; they 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.

  • UNII R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • UNII 12F08874Y7
    A natural extract from grapefruit seeds used as a preservative and antimicrobial agent in medicines. It helps prevent bacterial and fungal growth to maintain product stability and safety.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 8LGU7VM393
    Rosemary leaf oil is a natural aromatic oil extracted from rosemary plants. It's used in medicines as a flavoring agent and preservative to help protect the product from spoilage.
  • UNII C269C4G2ZQ
    Sodium alginate is a natural thickener and gelling agent derived from seaweed. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust texture, and a disintegrant to help the tablet or capsule break apart for absorption.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • 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.

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

The official label also statesInactive Ingredients: Distilled water, Glycerin, Boric acid, Sodium hydroxide, Sodium alginate, Rosemary oil, Sorbic acid, Tea tree oil, Grapefruit seed extract, Lactose "prepared using rhythmical processes"

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 gPer 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
Polygonatum Cepa 2 [hp_X]/g; 2 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 6 [hp_X]/g; 8 [hp_X]/g; 8 [hp_X]/g; 8 [hp_X]/g; 8 [hp_X]/g; 8this 48951-8310-05 Uriel 60 g — — 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

🏛️
2009
On the market since
Sep 2009
📍
2026
Currently FDA-listed
17 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
48951-8310-05 You're viewing this 60 g in 1 TUBE (48951-8310-5) 2009-09-01 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Polygonatum Cepa 2 [hp_X]/g; 2 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 6 [hp_X]/g; 8 [hp_X]/g; 8 [hp_X]/g; 8 [hp_X]/g; 8 [hp_X]/g; 8 GEL 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 48951-8310-5, 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: 48951-8310-05, written without dashes as 48951831005. 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 48951-8310-05, the first segment (48951) is the labeler code FDA assigned to Uriel Pharmacy Inc.; the middle segment (8310) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Uriel Pharmacy Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Uriel Pharmacy 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 5 words ▾

Directions: FOR TOPICAL USE ONLY

⏱️ Dosage and Administration 11 words ▾

Apply to skin as needed. Under age 2: Consult a doctor.

⚠️ Warnings 66 words ▾

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Contains traces of lactose. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.

🧪 Active Ingredient 73 words ▾

Active Ingredients: Allium cepa (Onion) 2X, Echinacea (Purple coneflower) 2X, Hirudo (Leech) 4X, Polygonatum (Solomon’s seal) 4X, Vespa crabro (Hornet) 6X, Aurum met. (Metallic gold) 8X, Cartilago articularis (Bovine cartilage) 8X, Cuprum met. (Copper) 8X, Cutis (feti) (Porcine skin) 8X, Placenta (bovis) (Bovine placenta) 8X, Quartz (Rock crystal) 8X, Thuja (American arborvitae) 8X, Mesenchyme (Porcine embryonic connective tissue) 10X, Argentum met.

(Silver) 12X, Barium citricum (Barium citrate) 12X, Graphites (Foliated crystalline carbon) 17X

🧪 Inactive Ingredients 26 words ▾

Inactive Ingredients: Distilled water, Glycerin, Boric acid, Sodium hydroxide, Sodium alginate, Rosemary oil, Sorbic acid, Tea tree oil, Grapefruit seed extract, Lactose "prepared using rhythmical processes"

🎯 Purpose 7 words ▾

Uses: Promotes skin regeneration and minimizes scars.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 48951-8217-02 · Uriel 48951-8326-06 · Uriel →
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.