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N-25 SERENOA REPENS WHOLE, AGATHOSMA CRENULATA WHOLE, Chimaphila umbellata, ELYMUS REPENS WHOLE, SELENIUM, and BOS TAURUS PROSTATE GLAND 2 [hp_X]/mL; 2 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 6 [hp_X]/mL; 200 [hp_X]/mL Solution, 29.57 mL — NDC 58264-0223-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

N-25 SERENOA REPENS WHOLE, AGATHOSMA CRENULATA WHOLE, Chimaphila umbellata, ELYMUS REPENS WHOLE, SELENIUM, and BOS TAURUS PROSTATE GLAND 2 [hp_X]/mL; 2 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 6 [hp_X]/mL; 200 [hp_X]/mL Solution, 29.57 mL — NDC 58264-0223-1 (Billing 58264-0223-01)

by DNA Labs, Inc. · 29.57 mL in 1 BOTTLE, GLASS

This is a package of 29.57 mL of N-25 SERENOA REPENS WHOLE, AGATHOSMA CRENULATA WHOLE, Chimaphila umbellata, ELYMUS REPENS WHOLE, SELENIUM, and BOS TAURUS PROSTATE GLAND 2 [hp_X]/mL; 2 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 6 [hp_X]/mL; 200 [hp_X]/mL Solution from DNA Labs, Inc., marketed since Jan 1990 and currently FDA-listed. It is this product's only package size.

NDC 58264-0223-01
🏷️ FDA NDC (as labeled) 58264-0223-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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 58264-0223-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58264 labeler · 0223 product · 1 package
Package marketed since
Jan 1, 1990
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5826402231 4
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58264-0223-1
Product NDC 58264-0223
11-digit billing NDC 58264022301
UNII 487DXM62F2, B6642J883V, WCK21A9W9J, BE5076899X, H6241UJ22B, 1P66FXU2MW
SPL Set ID db4f1434-c26b-4526-95d1-00099bf77839
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1990-01-01
Route SUBLINGUAL
Dosage form SOLUTION
Substance SERENOA REPENS WHOLE; AGATHOSMA CRENULATA WHOLE; CHIMAPHILA UMBELLATA; ELYMUS REPENS WHOLE; SELENIUM; BOS TAURUS PROSTATE GLAND
Why two NDCs? The FDA registers this code as 58264-0223-1 — 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 → 58264-0223-01. 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.

Clinical

🧪 What is this product?

This is an unapproved homeopathic solution taken under the tongue. It contains extracts of saw palmetto, buchu leaf, pipsissewa, couch grass, selenium, and bovine prostate gland tissue. In homeopathic practice, these ingredients are traditionally used to address urinary and prostate-related concerns, though homeopathic products are marketed based on traditional use rather than scientific evidence and are not 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.

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
58264-0223-01 You're viewing this Main listing 29.57 mL in 1 BOTTLE, GLASS 1990-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
N-25 2 [hp_X]/mL; 2 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 6 [hp_X]/mL; 200 [hp_X]/mLthis 58264-0223-01 DNA 29.57 ml — — 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

🏛️
1990
On the market since
Jan 1990
📍
2026
Currently FDA-listed
36 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.

  • 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.
  • 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 states20% alcohol in 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

LabelerDNA Labs, Inc.
Labeler code58264
First marketedJan 1990
Product typeHuman Otc Drug
Portfolio315 products on file

More NDCs from DNA Labs, Inc. labeler code 58264

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

INDICATIONS Support for the Prostate frequent and scanty urination in men.

⏱️ Dosage and Administration 21 words ▾

SUGGESTED DOSAGE One dropper under tongue two times daily. Acute symptoms ½ dropper under tongue every 30 minutes for two hours.

⚠️ Warnings 29 words ▾

Warnings Use only if cap seal is unbroken. If pregnant or breastfeeding, ask a healthcare professional before use. Keep this and all medication out of the reach of children.

🧪 Active Ingredient 25 words ▾

INGREDIENTS ACTIVE Sabal serrulata 2x, Barosma crenata 2x, Chimaphila umbellata 3x, Triticum repens 3x, Selenium metallicum 6x, Prostate 6/12/30/60/200x INACTIVE 20% alcohol in purified water.

🧪 Inactive Ingredients 6 words ▾

INACTIVE 20% alcohol in purified water.

🎯 Purpose 10 words ▾

Support for the Prostate frequent and scanty urination in men.

📄 When Using This Product 7 words ▾

Use only if cap seal is unbroken.

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 11 words ▾

Keep this and all medication out of the reach of children.

📄 Package Label / Principal Display Panel 22 words ▾

PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label DYNAMIC NUTRITIONAL ASSOCIATES, INC. N-25 PROSTATE ENERGIZER HOMEOPATHIC ENDOCRINE 1 FL. OZ. N-25

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

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 N-25 (this brand).

Top reported reactions

Transplant Rejection2
Abdominal Discomfort1
Abdominal Pain1
Anhedonia1
Aortic Valve Incompetence1
Aortic Valve Sclerosis1
Asthenia1

Reporter sex

3 reports
Female · 100%

Serious outcomes

Hospitalization3
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.

About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

N-25 SERENOA REPENS WHOLE, AGATHOSMA CRENULATA WHOLE, Chimaphila umbellata, ELYMUS REPENS WHOLE, SELENIUM, and BOS TAURUS PROSTATE GLAND 2 [hp_X]/mL; 2 [hp_X]/mL; 3 [hp_X]/mL; 3 [hp_X]/mL; 6 [hp_X]/mL; 200 [hp_X]/mL SOLUTION 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 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 DNA Labs, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
DNA Labs, 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.
← 58264-0222-01 · DNA 58264-0224-01 · DNA →
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.