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anti-dandruff 3 g/100mL Shampoo, 300 mL — NDC 84558-0010-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

anti-dandruff 3 g/100mL Shampoo, 300 mL — NDC 84558-010-01 (Billing 84558-0010-01)

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

This is a package of 300 mL of anti-dandruff 3 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 84558-0010-01
🏷️ FDA NDC (as labeled) 84558-010-01 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) 84558-010-01
Product NDC 84558-010
11-digit billing NDC 84558001001
RxCUI 205023
UNII O414PZ4LPZ
Application # M032
SPL Set ID 3979fb80-8091-c79e-e063-6394a90ae618
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-09
Route TOPICAL
Dosage form SHAMPOO
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 205023
Why two NDCs? The FDA registers this code as 84558-010-01 — 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 → 84558-0010-01. 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.

RxNorm drug class

This medicine belongs to the Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives, Other antifungals for topical use, Antiinflammatory agents, non-steroids
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or b...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It is used in a facial routine for acne-prone and oil-prone skin. The routine includes a cleanser, serum, toner and emulsion. Salicylic acid helps loosen and shed dead skin cells.
  • Use the cleanser morning and evening, and the serum in the morning after cleansing. Use the toner in the evening on dry skin, and the emulsion at night after cleansing. Avoid your...
  • Mild stinging, burning, itching, dryness and extra peeling can happen. If dryness or peeling bothers you, try using the serum or toner every other day. If it gets excessive, stop a...
  • It is best not to. Using another topical acne medication at the same time makes irritation and dryness more likely. If you get irritated, use only one at a time.
📖 Read our full Salicylic Acid Topical guide →

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
84558-0010-01 You're viewing this Main listing 300 mL in 1 BOTTLE 2025-07-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Therapeutic Dandruff Anti-Dandruff, anti-seborrheic dematitis and anti-psoriasis 30 mg/mL 70000-0550-01 Cardinal 133 ml $0.022 — Availability likely —
DHS SAL 4 oz. .035 g/g 00096-0738-04 Person 123.84 g — — FDA listed —
Dhs Sal 30 mg/mL 00096-0812-04 Person 120 ml — — FDA listed —
Walgreens Tplus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 30 mg/mL 00363-2735-01 Walgreen 133 ml — — FDA listed —
Walgreens Dandruff Itchy Dry Scalp Defense Plus Vitamins and Botanicals Anti-dandruff 30 mg/mL 00363-4137-01 Walgreen 325 ml — — FDA listed —
Walgreens 30 mg/mL 00363-9536-07 Walgreens 207 ml — — FDA listed —
Walgreens 30 mg/mL 00363-9537-11 Walgreens 325 ml — — FDA listed —
TriDerma Itchy Scalp 3 g/100g 10738-0045-23 Genuine 370 g — — FDA listed —
TRIDERMA Psoriasis Control 3 g/100mL 10738-0980-50 Genuine 1 tube — — FDA listed —
Selsun Blue Naturals Itchy, Dry Scalp .03 g/mL 41167-6180-03 Chattem, 325 ml — — FDA listed —
Dr. Groot Anti-dandruff Scalp Care 30 mg/mL 43136-0701-01 TAI 300 ml — — FDA listed —
Dr. Groot Anti-dandruff Scalp Care 2 in 1 30 mg/mL 43136-0702-01 TAI 300 ml — — FDA listed —
CVS Health MAXIMUM STRENGTH Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 30 mg/mL 51316-0443-01 CVS 1 bottle — — FDA listed —
Dr. Groot Anti-dandruff Scalp Care 30 mg/mL 53208-0901-36 LG 300 ml — — FDA listed —
Dr. Groot Anti-dandruff Scalp Care 2 in 1 30 mg/mL 53208-0902-36 LG 300 ml — — FDA listed —
Nizoral Psoriasis 3 g/100mL 55505-0202-64 Kramer 1 bottle — — FDA listed —
XtraCare Dandruff Hair Wash 10 g/325g 57337-0053-01 Rejoice 325 g — — FDA listed —
Cantu Guava Ginger Anti Dandruff .03 g/mL 61012-0740-13 PDC 400 ml — — FDA listed —
Denorex Extra Strength .03 g/mL 62673-0059-10 Neoteric 296 ml — — FDA listed —
Denorex Multi-Symptom Anti-Dandruff .03 g/mL 62673-0060-10 Neoteric 296 ml — — FDA listed —
Dermarest Psoriasis Medicated 3 g/100mL 63736-0302-24 Insight 1 bottle — — FDA listed —
bhs beautiful hair and scalp 3 g/100mL 64942-1973-01 Conopco, 400 ml — — FDA listed —
bhs beautiful hair and scalp 3 g/100mL 64942-2063-01 Conopco, 400 ml — — FDA listed —
Therapeutic TPlus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 30 mg/mL 67385-0512-01 Garcoa, 133 ml — — FDA listed —
MG217 Psoriasis Therapeutic Conditioner .03 g/g 68093-7242-01 Wisconsin 1 bottle — — FDA listed —
Neutrogena T/Sal Therapeutic 30 mg/mL 69968-0434-01 Kenvue 12 bottles — — FDA listed —
Neutrogena Scalp Therapy Anti-Dandruff Extra Strength 30 mg/mL 69968-0723-01 Kenvue 354 ml — — FDA listed —
NTG T/Sal 3% Salicylic Acid Anti-Dandruff for Scalp Build Up Control 30 mg/mL 69968-0938-08 Kenvue 1 bottle — — FDA listed —
Neutrogena T/Sal Plus 3% Salicylic Acid Anti-Dandruff for Dry, Itchy Scalp Control 30 mg/mL 69968-0939-08 Kenvue 1 bottle — — FDA listed —
Dermaharmony Unscented Bar 3 g/100g 71819-0020-04 D3 113 g — — FDA listed —
Kenkoderm Psoriasis 3 g/100mL 73632-0003-01 Olympus 118 ml — — FDA listed —
Pert 2 in 1 Extra Strength 3 g/100mL 81277-0803-12 Sodalis 355 ml — — FDA listed —
upandup Anti-dandruff with Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis 30 mg/mL 82442-0743-01 TARGET 355 ml — — FDA listed —
HAIRCARE Physicians Recommended 30 mg/mL 82499-0267-00 LAWRENCE 237 ml — — FDA listed —
Scalp Revival 3 g/100mL 82594-0001-50 Beccair, 248 ml — — FDA listed —
Neoketramin Antifungal Dandruff Seborrheic Dermatitis Psoriasis Treatment 3 g/100mL 83004-0019-01 Rida 1 tube — — Discontinued —
Quality Choice Therapeutic 3 g/100mL 83324-0295-45 Chain 1 bottle — — FDA listed —
Quality Choice Psoriasis 3 g/100mL 83324-0342-11 Chain 1 bottle — — FDA listed —
Dermoia Psoriasis Treatment Salicylic Acid 30 mg/mL 83524-0945-00 Treasurewise 355 ml — — FDA listed —
DermaSolve Medicated 3 g/100g 84285-0101-08 Fortitude 226 g — — FDA listed —
anti-dandruff 3 g/100mLthis 84558-0010-01 GUANGZHOU 300 ml — — FDA listed —
VERB PRODUCTS Balance Relief Salicylic Acid Dandruff Clinical Strength 30 mg/mL 84607-0545-00 Verb 235 ml — — FDA listed —
Shailee Psoriasis Treatment 3 g/100mL 84938-0008-01 Foshan 1 bottle — — FDA listed —
Pharmlitalia Psoriasis Treatment 3 g/100mL 84938-0019-01 Foshan 1 bottle — — FDA listed —
Listarfe Anti-Dandruff Shampoo. 3 g/100mL 85150-0005-01 Guangzhou 300 ml — — FDA listed —
Quality Choice Therapeutic 3 g/100mL 85161-0295-45 Longway 1 bottle — — FDA listed —
Quality Choice Psoriasis 3 g/100mL 85161-0342-11 Longway 1 bottle — — FDA listed —
Kenkoderm Psoriasis 3 g/100mL 85286-0003-01 Nexgel,Inc. 118 ml — — FDA listed —
RoyceDerm Seborrheic Dermatitis and Psoriasis shampoo. 7.5 g/250g 85424-0015-01 RoyceDerm 250 g — — FDA listed —
RoyceDerm Seborrheic Dermatitis and Psoriasis Shampoo. 7.5 g/250g 85424-0020-01 RoyceDerm 250 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

🏛️
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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent 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.
  • UNII 6SO6U10H04
    Biotin is a B-vitamin used as a nutritional supplement in some medications. It may also serve as a colorant or marker in formulations.
  • UNII 459EF9MP3Y
    A synthetic surfactant derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water components together in the medicine formulation.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • 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 ICS790225B
    A plant-derived cleaning agent made from coconut oil and glucose. It works as a surfactant and emulsifier to help mix oil and water-based ingredients together in the formulation.
  • UNII 5EM498GW35
    A mixture of aromatic compounds used to add pleasant smell to the medicine. Fragrance helps mask unpleasant tastes or odors, making the medication easier to take.
  • UNII C5529G5JPQ
    Ginger is a plant-derived ingredient used as a flavoring agent to add taste and aroma to medicines. It may also provide mild soothing properties to support product palatability.
  • 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 25KRT26H77
    A synthetic organic compound used as a preservative and antioxidant in medicines. It helps prevent breakdown and spoilage of the active ingredients during storage.
  • UNII 23D6XVI233
    Lauramidopropyl betaine is a mild cleanser and foaming agent derived from coconut oil. In medicines, it helps create a smooth texture, reduce foam, and improve how the product spreads or mixes.
  • UNII 834K0WOS5G
    A natural fat extracted from sunflower seeds. It acts as an emulsifier and lubricant in medicines, helping mix ingredients that don't normally blend together and allowing the product to flow smoothly during manufacturing.
  • UNII N91S91EFOG
    A carbohydrate derived from starch that acts as a binder and filler in tablets and capsules. It helps hold ingredients together and adds bulk to the formulation.
  • 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 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 H41B6Q1I9L
    A naturally derived antimicrobial compound found in plant oils. It's added to medicines as a preservative to help prevent bacterial and fungal growth and extend shelf life.
  • UNII CUQ3A77YXI
    Panax ginseng root is a plant extract traditionally used in herbal preparations. In medications, it may serve as an active botanical ingredient or be included for flavoring and as a natural preservative or binder in formulations.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII YM0K64F20V
    A synthetic emulsifier derived from polyethylene glycol and glucose. It helps blend oil and water-based ingredients together and improves the texture and spreadability of the product.
  • 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 A4V5C6R9FB
    Piroctone olamine is a antimicrobial compound used in medicines as a preservative or antifungal agent. It helps prevent bacterial and fungal growth in topical formulations like shampoos and skin products.
  • UNII 32E5V7G32B
    A plant extract from Oriental arborvitae leaves, used in formulations as a natural flavoring agent, fragrance component, or preservative to enhance taste, aroma, or shelf stability.
  • UNII L45WU8S981
    A synthetic polymer derived from cellulose, polyquaternium-10 acts as a thickener and film-former in liquid formulations. It increases viscosity for better texture and helps the product adhere to or coat skin or mucous membranes.
  • UNII IJ67X351P9
    A natural plant extract from rosemary leaves used as a preservative to help prevent oils and fats in the medicine from spoiling or becoming rancid during storage.
  • UNII 632GS99618
    Sodium lauroyl sarcosinate is a mild, plant-derived cleaning agent used in medicines as a surfactant and emulsifier. It helps mix oil and water-based ingredients and may aid tablet disintegration.

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

The official label also statesAqua, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betaine, Lauramidopropyl Betaine,Lecithin, Coco-Glucoside, Peg-120 MethyI Glucose Dioleate, Aloe Barbadensis Leaf Extract, HydroxyphenyI Propamidobenzoic Acid, Phenoxyethanol, Menthol, Polyquaternium 10, Panthenol, Maltooligosyl Glucoside, Lindera Strychnifolia Extract, Carbomer, Piroctone Olamine, Glycerin, Biotin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thuja Orientalis Leaf Extract, Panax Ginseng Root Extract, Angelica Sinensis Extract, Zingiber Officinale (Ginger) Root Extract, Polygonum Multiflorum Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Fragrance, O-Cymen-5-Ol, Hydroxypropyltrimonium Hyaluronate, C12-15 Pareth-3, Hydroxypropyltrimonium Hydrolyzed Collagen

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 16 words ▾

Use Helps prevent recurrence of the scalp: irritation, itching, redness, flaking and scaling associated with dandruff

⏱️ Dosage and Administration 41 words ▾

Directions 1. For best results, use at least twice a week or as directed by a doctor 2. Wet hair thoroughly, massage shampoo into scalp, leave on for 3-5 minutes to allow maximum absorption. Then rinse thoroughly and repeat as needed

⚠️ Warnings 60 words ▾

Warnings For external use only Consult a doctor before use if you ■ are allergic to ingredients in this product When using this product ■ avoid contact with eyes ■ if contact occurs, rinse eyes thoroughly with water Stop use and consult a doctor if ■ condition worsens or does not improve after regular use of this product as directed

📦 Storage and Handling 4 words ▾

Other information No Data

🧪 Active Ingredient 5 words ▾

Active Ingredient(s) Salicylic acid 3%

🧪 Inactive Ingredients 76 words ▾

Inactive ingredients Aqua, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betaine, Lauramidopropyl Betaine,Lecithin, Coco-Glucoside, Peg-120 MethyI Glucose Dioleate, Aloe Barbadensis Leaf Extract, HydroxyphenyI Propamidobenzoic Acid, Phenoxyethanol, Menthol, Polyquaternium 10, Panthenol, Maltooligosyl Glucoside, Lindera Strychnifolia Extract, Carbomer, Piroctone Olamine, Glycerin, Biotin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thuja Orientalis Leaf Extract, Panax Ginseng Root Extract, Angelica Sinensis Extract, Zingiber Officinale (Ginger) Root Extract, Polygonum Multiflorum Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Fragrance, O-Cymen-5-Ol, Hydroxypropyltrimonium Hyaluronate, C12-15 Pareth-3, Hydroxypropyltrimonium Hydrolyzed Collagen

🎯 Purpose 2 words ▾

Purpose Anti-dandruff

📄 Do Not Use 14 words ▾

Do not use Do not use if allergic to the ingredients in this product

📄 When Using This Product 14 words ▾

1. avoid contact with eyes 2. if contact occurs, rinse eyes thoroughly with water

📄 Stop Use and Ask a Doctor If 14 words ▾

condition worsens or does not improve after regular use of this product as directed

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

📄 Package Label / Principal Display Panel 8 words ▾

Package Label - Principal Display Panel undefined undefined

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 ✓ 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 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.
← 84558-0009-01 · GUANGZHOU 84558-0011-01 · 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.