HomeNDC Lookup › 84260-0010-03
Extended topical sprays for men CLOVE,ZANTHOXYLUM BUNGEANUM FRUIT,CYNOMORIUM COCCINEUM SUBSP.SONGARICUM WHOLE,CNIDIUM MONNIERI WHOLE .6 g/100mL; 9.5 g/100mL; 2.8 g/100mL; 1.2 g/100mL Liquid, 10 mL — NDC 84260-0010-03 package photo

Extended topical sprays for men CLOVE,ZANTHOXYLUM BUNGEANUM FRUIT,CYNOMORIUM COCCINEUM SUBSP.SONGARICUM WHOLE,CNIDIUM MONNIERI WHOLE .6 g/100mL; 9.5 g/100mL; 2.8 g/100mL; 1.2 g/100mL Liquid, 10 mL

by Guangzhou Lvying Biotechnology Co., Ltd · 10 mL in 1 BOTTLE (84260-010-03)
NDC 84260-0010-03
🏷️ FDA NDC (as labeled) 84260-010-03 billing pads the product segment with a zero
This package
Contains10 mL Pack sizes3 compare ↓
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 84260-010-03
Product NDC 84260-010
11-digit billing NDC 84260001003
UNII 3CIP16A418, 4AF9K48H9O, K48IKT5321, GYR30735RE
Application # 505G(a)(3)
SPL Set ID 30101650-2bd1-6ab0-e063-6394a90a28c5
Established class (EPC) Non-Standardized Plant Allergenic Extract; Non-Standardized Food Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens; Dietary Proteins; Plant Proteins; Food Additives
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-13
Route TOPICAL
Dosage form LIQUID
Substance ZANTHOXYLUM BUNGEANUM FRUIT; CYNOMORIUM COCCINEUM SUBSP. SONGARICUM WHOLE; CLOVE; CNIDIUM MONNIERI WHOLE
Why two NDCs? The FDA registers this code as 84260-010-03 — 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 → 84260-0010-03. 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

LabelerGuangzhou Lvying Biotechnology Co., Ltd
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code84260
First marketedMar 2025
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?

This is a topical spray liquid marketed as an over-the-counter monograph product for men. It contains plant extracts including clove, zanthoxylum bungeanum fruit, cynomorium coccineum, and cnidium monnieri whole, which are traditional botanical ingredients commonly used in topical preparations. These plant materials are typically featured in products aimed at topical application, though this is a non-standardized plant extract formulation regulated under the OTC drug monograph system rather than through individual FDA review.

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 LM25W02G91
    A plant-derived ingredient from the cistanche deserticola species. It's used as a natural filler and functional component to add bulk and potentially enhance the formulation's bioavailability in herbal or traditional medicine products.
  • UNII 00IF91KFKQ
    A natural extract from saffron crocus flowers. Used in medicines as a coloring agent to give products a golden-yellow hue and sometimes to add subtle flavor or aroma to the formulation.
  • UNII 56UJF6417L
    Epimedium brevicornu whole is a plant extract used in some formulations as a natural ingredient. It may function as a flavoring agent, colorant, or active botanical component depending on the specific medicine.
  • UNII UV4X7MQQ43
    A plant extract from Japanese honeysuckle used as a natural flavoring and fragrance agent in medicines. It may also provide mild preservative or soothing properties to the formulation.
  • 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.

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

The official label also statesWATER CISTANCHE DESERTICOLA WHOLE EPIMEDIUM BREVICORNU WHOLE LONICERA JAPONICA WHOLE CROCUS SATIVUS FLOWER

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 DailyMedingredient 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 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.
Try another pack size: 1 ml 5 ml
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
Extended topical sprays for men .6 g/100mL; 9.5 g/100mL; 2.8 g/100mL; 1.2 g/100mLthis 84260-0010-03 Guangzhou 10 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

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year 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
84260-0010-01 1 mL in 1 BOTTLE (84260-010-01) 2025-03-14 Active
84260-0010-02 5 mL in 1 BOTTLE (84260-010-02) 2025-03-14 Active
84260-0010-03 You're viewing this 10 mL in 1 BOTTLE (84260-010-03) 2025-03-14 Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 84260-0010-03?
NDC 84260-0010-03 contains 10 mL — 10 ml in 1 bottle.
What is the difference between NDC 84260-0010-03 and NDC 84260-0010-01?
Both are Extended topical sprays for men CLOVE,ZANTHOXYLUM BUNGEANUM FRUIT,CYNOMORIUM COCCINEUM SUBSP.SONGARICUM WHOLE,CNIDIUM MONNIERI WHOLE .6 g/100mL; 9.5 g/100mL; 2.8 g/100mL; 1.2 g/100mL Liquid — the drug itself is identical. NDC 84260-0010-03 is the 10 mL package, while NDC 84260-0010-01 is the 1 ml package.
What NDC number is used to bill for this package of Extended topical sprays for men CLOVE,ZANTHOXYLUM BUNGEANUM FRUIT,CYNOMORIUM COCCINEUM SUBSP.SONGARICUM WHOLE,CNIDIUM MONNIERI WHOLE .6 g/100mL; 9.5 g/100mL; 2.8 g/100mL; 1.2 g/100mL Liquid?
Bill NDC 84260-0010-03 — the 11-digit billing format is 84260001003. 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
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 "Otc Monograph Drug". 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 84260-010-03, 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: 84260-0010-03, written without dashes as 84260001003. 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 84260-0010-03, the first segment (84260) is the labeler code FDA assigned to Guangzhou Lvying Biotechnology Co., Ltd; the middle segment (0010) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Guangzhou Lvying Biotechnology Co., Ltd. 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 2 other package presentations of this same product, including 1 ml (84260-0010-01), 5 ml (84260-0010-02). 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?
Guangzhou Lvying Biotechnology Co., Ltd 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 21 words

Take an appropriate amount of this product and spray it on the desired area of the man 30 minutes in advance.

⏱️ Dosage and Administration 21 words

Take an appropriate amount of this product and spray it on the desired area of the man 30 minutes in advance.

⚠️ Warnings 10 words

Keep away fom fire or flame for external use only.

📦 Storage and Handling 25 words

Away from direct sunlight and keep in cool place. Keep out of reach of Children. Keep away from fire or flame for external use only.

🧪 Active Ingredient 16 words

CYNOMORIUM COCCINEUM SUBSP SONGARICUM WHOLE 9.5% CLOVE 2.8% CNIDIUM MONNIERI WHOLE 1.2% ZANTHOXYLUM BUNGEANUM FRUIT 0.6%

🧪 Inactive Ingredients 13 words

WATER CISTANCHE DESERTICOLA WHOLE EPIMEDIUM BREVICORNU WHOLE LONICERA JAPONICA WHOLE CROCUS SATIVUS FLOWER

🎯 Purpose 5 words

Extended topical sprays for men

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