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anti-fungal .08 g/100mL; 2 g/100mL Shampoo, 300 mL — NDC 84558-012-01 (Billing 84558-0012-01)

by GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd · 300 mL in 1 BOTTLE

This is a package of 300 mL of anti-fungal .08 g/100mL; 2 g/100mL Shampoo from GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 84558-0012-01
🏷️ FDA NDC (as labeled) 84558-012-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84558-012-01
Product NDC 84558-012
11-digit billing NDC 84558001201
RxCUI 2720077
UNII A4V5C6R9FB, O414PZ4LPZ
UPC 0686585187598
Application # M032
SPL Set ID 3b102d15-f2ce-5727-e063-6294a90a23a9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-30
Route TOPICAL
Dosage form SHAMPOO
Substance PIROCTONE OLAMINE; SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 2720077
Why two NDCs? The FDA registers this code as 84558-012-01 — 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 → 84558-0012-01. 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 over-the-counter antifungal shampoo containing piroctone olamine and salicylic acid. Piroctone olamine is typically used to help control fungal growth on the scalp, while salicylic acid functions as a keratolytic agent that helps soften and remove dead skin and buildup. The shampoo is applied topically to the hair and scalp. This product is marketed under the FDA's OTC drug monograph rules for antifungal shampoos.

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
84558-0012-01 You're viewing this Main listing 300 mL in 1 BOTTLE 2025-07-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
anti-fungal .08 g/100mL; 2 g/100mLthis 84558-0012-01 GUANGZHOU 300 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
Jul 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.

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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • UNII 2ACZ6IPC6I
    A naturally occurring compound in the body that acts as a neurotransmitter. In medicines, it may serve as a buffer or pH regulator to help stabilize the formulation and maintain proper acidity levels.
  • 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.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII S96N10R972
    A natural plant extract from cinchona bark, traditionally used in medicines. It may function as a flavoring agent or bitter principle to mask taste or add therapeutic properties to formulations.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII VAD2K35XAJ
    A carbohydrate polymer made from corn starch through partial breakdown. It acts as a binder to hold tablet ingredients together and as a filler to give the tablet proper size and texture.
  • UNII 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • UNII BYR0546TOW
    DMDM hydantoin is a preservative chemical used to prevent the growth of bacteria and fungi in medicines. It helps keep the product safe and stable throughout its shelf life.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 13W7MDN21W
    A waxy compound made from glycol and stearic acid. It's used as an emulsifier to help blend oil and water-based ingredients, and as a thickener to give the medicine its desired texture and consistency.
  • UNII 0324G66D0E
    Glycol stearate is a waxy compound made by combining stearic acid with ethylene glycol. It acts as an emulsifier and thickener, helping keep oil and water mixed together smoothly in liquid or semi-solid medicines.
  • UNII 1530WMS90S
    A thickening agent derived from guar gum, a natural polysaccharide from guar bean seeds. It increases viscosity in liquid formulations to improve texture, stability, and how the medicine flows or coats.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
  • UNII ED959S6ACY
    A sweet liquid made by breaking down regular sugar into simpler sugars. It's used in medicines as a sweetener and to improve taste, and also helps control moisture and texture in the product.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII 2BF9E65L7I
    A chemical compound combining menthol with lactic acid. It's used in medicines as a flavoring agent and to provide a cooling or soothing sensation on the skin or mouth.
  • UNII PBG27B754G
    Phellodendron amurense bark is a plant-derived ingredient from the cork tree. It functions as a natural preservative and antimicrobial agent to help maintain product stability and prevent microbial growth.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII GMR4PEN8PK
    A synthetic polymer used as a thickener and film-former in liquid formulations. It increases viscosity to improve texture and help the medicine spread or adhere evenly on the skin or mucous membranes.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII G2HC85101Q
    A natural plant extract from the Rosa laevigata fruit, used in medicines as a flavoring agent, colorant, or traditional ingredient to enhance taste and appearance of the formulation.
  • UNII W8K377W98I
    A mixture of sugars made by rearranging glucose molecules. It acts as a sweetener and filler to improve taste and add bulk to the medicine while helping it hold together.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII BPV390UAP0
    Sodium laureth sulfate is a mild detergent and surfactant derived from coconut oil or petroleum. It helps mix oil and water in formulations and is often used as a cleaning or foaming agent in topical products like shampoos and cleansers.
  • UNII SE337SVY37
    A mineral salt used as a buffer to help maintain the medicine's pH level and prevent breakdown of active ingredients. It also acts as a thickening agent in liquid formulations.
  • UNII IYR6K8KQ5K
    A plant extract from sophora flavescens root used as a natural colorant and flavoring agent in medicines. It may also help preserve the product and provide texture.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.

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

The official label also statesAQUA, SODIUM LAURETH SULFATE, SODIUM CHLORIDE, GLYCOL DISTEARATE, PAL.M KERNEL AMIDE DEA, SODIUM L AUROYL COLLAGEN AMINO ACIDS, COCAMIDOPROPYL BETAINE, FRAGRANCE, SORBITOL, GLYCOL STEARATE, DMDM HYDANTOIN, SACCHARIDE HYDROLYSATE, ALOE BARBADENSIS L EAF JUICE, HYDROXYETHYLCELLULOSE, GLYCERIN, BUTYL ENE GLYCOL, HYDROXYPROPYL GUAR, POLYQUATERNIUM-10, CITRIC ACID, CINCHONA PUBESCENS BARK EXTRACT, MENTHYL LACTATE, SOPHORA FLAVESCENS ROOT EXTRACT，PHEL LODENDRON AMURENSE BARK EXTRACT, ATRACTYLODES CHINENSIS RHIZOME EXTRACT, DEXTRIN, PHENOXYETHANOL, SACCHARIDE ISOMERATE, AMINOBUTYRIC ACID, 1,2-HEXANEDIOL, ETHYL HEXYL GLYCERIN, POLYSORBATE 60, DISODIUM PHOSPHATE, MENTHOLUM, HYDROXYACETOPHENONE, VIOL A YEDOENSIS EXTRACT, SODIUM PHOSPHATE, ROSA L AEVIGATA FRUIT EXTRACT, SESAME AMINO ACIDS

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

LabelerGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code84558
First marketedJul 2025
Product typeHuman Otc Drug
Portfolio26 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.

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 20 words ▾

Use Relieves and helps prevent recurrence of scalp: itching, flaking, scaling, redness, and iritation associated with psoriasis and seborrheic dermatitis.

⏱️ Dosage and Administration 46 words ▾

Directions 1. Apply shampoo and massage into scalp. 2. Leave in hair for 3- 5 minutes to allow maximum penetration. 3. Rinse and repeat as needed. 4. Use daily for best results. 5. Do not use on children under 2 years unless directed by a doctor.

⚠️ Warnings 18 words ▾

Warnings For external use only Ask a doctor before use if you have allergic reactions to this product

📦 Storage and Handling 11 words ▾

Other information Store at room temperature and out of direct sunlight

🧪 Active Ingredient 8 words ▾

Active Ingredient(s) SALICYLIC ACID 2% PIROCTONE OLAMINE 0.08%

🧪 Inactive Ingredients 94 words ▾

Inactive ingredients AQUA, SODIUM LAURETH SULFATE, SODIUM CHLORIDE, GLYCOL DISTEARATE, PAL .M KERNEL AMIDE DEA, SODIUM L AUROYL COLLAGEN AMINO ACIDS, COCAMIDOPROPYL BETAINE, FRAGRANCE, SORBITOL, GLYCOL STEARATE, DMDM HYDANTOIN, SACCHARIDE HYDROLYSATE, ALOE BARBADENSIS L EAF JUICE, HYDROXYETHYLCELLULOSE, GLYCERIN, BUTYL ENE GLYCOL, HYDROXYPROPYL GUAR, POLYQUATERNIUM-10, CITRIC ACID, CINCHONA PUBESCENS BARK EXTRACT, MENTHYL LACTATE, SOPHORA FLAVESCENS ROOT EXTRACT，PHEL LODENDRON AMURENSE BARK EXTRACT, ATRACTYLODES CHINENSIS RHIZOME EXTRACT, DEXTRIN, PHENOXYETHANOL, SACCHARIDE ISOMERATE, AMINOBUTYRIC ACID, 1,2-HEXANEDIOL, ETHYL HEXYL GLYCERIN, POLYSORBATE 60, DISODIUM PHOSPHATE, MENTHOLUM, HYDROXYACETOPHENONE, VIOL A YEDOENSIS EXTRACT, SODIUM PHOSPHATE, ROSA L AEVIGATA FRUIT EXTRACT, SESAME AMINO ACIDS

🎯 Purpose 8 words ▾

Purpose Scalp treatment fights itching and flaking Anti-dandruff

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
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 "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 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 GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
GUANGZHOU YUSONG FINE CHEMICLS 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.
← 84558-0011-01 · GUANGZHOU 84558-0013-01 · GUANGZHOU →
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.