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AOAO RAPID ACNE RELIEF Salicylic Acid,BENZOYL PEROXIDE 450 mg/15mL; 150 mg/15mL Cream, 15 mL — NDC 84509-0112-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

AOAO RAPID ACNE RELIEF Salicylic Acid,BENZOYL PEROXIDE 450 mg/15mL; 150 mg/15mL Cream, 15 mL — NDC 84509-112-01 (Billing 84509-0112-01)

by Guangzhou Senmai Biotechnology Co.,Ltd. · 15 mL in 1 BOTTLE

This is a package of 15 mL of AOAO RAPID ACNE RELIEF Salicylic Acid,BENZOYL PEROXIDE 450 mg/15mL; 150 mg/15mL Cream from Guangzhou Senmai Biotechnology Co.,Ltd., marketed since Aug 2026 and currently FDA-listed. It is this product's only package size.

NDC 84509-0112-01
🏷️ FDA NDC (as labeled) 84509-112-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 13, 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 84509-112-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84509 labeler · 112 product · 01 package
Package marketed since
Aug 7, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8450911201 4
FDA record last changed
Aug 13, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84509-112-01
Product NDC 84509-112
11-digit billing NDC 84509011201
UNII W9WZN9A0GM, O414PZ4LPZ
Application # M016
SPL Set ID 586df874-0f71-ed46-e063-6294a90a0a8e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-07
Route TOPICAL
Dosage form CREAM
Substance BENZOYL PEROXIDE; SALICYLIC ACID
Why two NDCs? The FDA registers this code as 84509-112-01 — 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 → 84509-0112-01. 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 topical cream containing two active ingredients commonly used in acne care products. Benzoyl peroxide and salicylic acid are typically used to help address acne-prone skin through different mechanisms: benzoyl peroxide functions as an antibacterial agent, while salicylic acid is commonly used to help exfoliate and clear pores. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for over-the-counter acne treatments rather than undergoing individual FDA review.

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
84509-0112-01 You're viewing this Main listing 15 mL in 1 BOTTLE 2026-08-07 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aoao Rapid Acne Relief 450 mg/15mL; 150 mg/15mLthis 84509-0112-01 Guangzhou 15 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 5C5403N26O
    Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
  • UNII SMF2K46G8D
    A red algae extract used as a gelling agent and thickener in medicines. It forms a gel-like consistency that helps control how the medicine releases and is absorbed in the body.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation 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 PKO39VY215
    A natural compound derived from Centella asiatica plant, used as an active botanical extract or skin-conditioning agent in topical formulations to support ingredient stability and product efficacy.
  • UNII F2VW3D43YT
    Azelaic acid is a naturally occurring compound that acts as a preservative and antimicrobial agent in medications. It helps prevent bacterial and fungal growth, extending the product's shelf life and stability.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • 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 UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • 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 4YS74Q4G4J
    A plant extract from Centella asiatica containing natural compounds called triterpenoids. It's used as an active ingredient in some formulations for its purported skin-supporting properties, though it functions as a botanical additive rather than a structural component of the medicine.
  • UNII F1X8L2B00J
    A naturally derived fatty substance that helps bind and condition the product's texture. It works as an emollient and skin-conditioning agent in topical formulations, helping maintain moisture and smoothness.
  • UNII CR0J8RN66K
    A waxy, skin-like substance derived from plants or synthesized in labs. It's used in topical products as an emollient and skin barrier component to help keep the formula smooth and improve how it feels on skin.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • UNII 8JC99XGU4W
    Soluble fish skin collagen is a protein derived from fish skin that acts as a binder and thickening agent in medicines. It helps hold ingredients together and gives the product the right texture or consistency.
  • UNII QG4PXU8G3H
    A plant extract from dendrobium orchids used as a natural ingredient. It may serve as a binder, thickener, or texture modifier in formulations.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII CA2Y0FE3FX
    A salt derived from licorice root extract, used as a flavoring agent and sweetener. It may also help soothe and protect mucous membranes in throat lozenges and cough products.
  • UNII 7GXZ3858RY
    Ectoine is a naturally derived protective compound used in pharmaceuticals as a stabilizer and humectant. It helps preserve the integrity of active ingredients and maintain moisture in formulations.
  • UNII EG3PA2K3K5
    Ethylhexyl stearate is a waxy oil made from stearic acid and ethylhexyl alcohol. In medicines, it acts as an emollient and thickener to improve texture and help the product spread smoothly on skin or dissolve properly.
  • 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 6YSS42VSEV
    Fructose is a natural sugar derived from fruits and plants. It's used in medicines as a sweetener and filler to improve taste and add bulk to tablets or syrups.
  • UNII GXZ33VNT92
    Gentiana scabra root is a plant extract used in some formulations as a flavoring agent and natural colorant. It may also serve to support the product's stability and shelf life.
  • UNII NNE56F2N14
    A synthetic compound derived from glycerin and polyethylene glycol. It acts as an emulsifier and solubilizer to help mix water and oil-based ingredients and keep them blended throughout the product's shelf life.
  • UNII TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
  • 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 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII VOD5H80TXG
    A plant-derived ingredient from the root of the common gromwell plant. It may function as a natural colorant or botanical additive in formulations, though its specific role varies by product.
  • UNII 463JZS0XJ3
    Cream is a mixture of water and oil used as a base or vehicle in medicines applied to skin. It helps deliver active ingredients while softening and moisturizing the affected area.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII 40KQ7Q535O
    A plant extract from white water lily flowers. It's used in formulations for its soothing and skin-conditioning properties, often included in topical products as a natural ingredient to enhance texture and feel.
  • 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 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 P5QZM4T259
    A synthetic polymer made from polyethylene glycol and polypropylene glycol chains. It acts as a binder and film-former to help hold tablet ingredients together and create protective coatings on medications.
  • 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 1T6N4D9YV6
    A natural fat-like substance derived from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and may improve how the body absorbs the active medicine.
  • UNII 233VSF903M
    A plant-derived oil compound used as an emollient and skin-conditioning agent. It helps soften the product texture and improve how the medicine spreads on or absorbs into the skin.
  • UNII M51422LRAM
    Polyglycerin-6 is a synthetic compound made from glycerin molecules linked together. In medicines, it acts as an emulsifier and humectant, helping mix oil and water-based ingredients and retain moisture in the formulation.
  • UNII 8D08K3S51E
    Propylene carbonate is a clear liquid solvent derived from propylene. It helps dissolve or suspend active ingredients in liquid medicines and can improve how well the product flows and mixes.
  • UNII G2SH0XKK91
    Retinol is a form of vitamin A derived from animal sources or synthesized in a lab. In medicines, it may serve as an active therapeutic ingredient in some formulations, though when listed as an excipient it functions as a skin-conditioning agent or antioxidant to help stabilize the product.
  • UNII 1D1K0N0VVC
    A fat-soluble form of vitamin A used as a colorant and nutritional fortification ingredient. It gives products a yellow or orange tint and increases vitamin A content in the formula.
  • UNII 7243K85WFO
    Sodium lauroyl lactylate is a mild surfactant derived from natural fats and lactic acid. It acts as an emulsifier and solubilizer to help blend oil and water-based ingredients and improve how the body absorbs the active drug.
  • UNII 285CYO341L
    Sodium polyacrylate is a synthetic polymer that absorbs and holds water. In medicines, it acts as a disintegrant, helping tablets break apart quickly in the stomach, and as a binder, holding tablet ingredients together.
  • UNII 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 3T5PCR2H0C
    A synthetic detergent and emulsifier made from plant-derived materials. It helps mix oil and water components together and improves how the medicine spreads or absorbs in the body.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII C32PQ86DH4
    Zinc PCA is a zinc salt of pyroglutamic acid, a naturally occurring amino acid derivative. It's used in medications as a skin-conditioning agent and to help maintain product stability and texture in topical formulations.

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

The official label also statesWater, Butylene Glycol, Azelaic Acid, Niacinamide, Glycereth-26, PEG/PPG-17/6 Copolymer, Dimethicone, Squalane, Skin Lipids, Ceramide NP, Ceramide EOP, Ceramide AP, o-Cymen-5-ol, Panthenol, Zinc PCA, Lecithin, Polyglycerin-6, Allantoin, Acacia Senegal Gum, Asiaticoside, Tocopherol, Centella Asiatica Extract, Ectoin, Bisabolol, Caprylic/Capric Triglyceride, Sodium Polyacrylate, Caprylhydroxamic Acid, Fructose, Ahnfeltiopsis Concinna Extract, Sodium Lauroyl Lactylate, Ethylhexyl Stearate, Collagen, Dipotassium Glycyrrhizate, Nymphaea Alba Flower Extract, Gentiana Scabra Root Extract, Retinyl Palmitate,Dendrobium Officinale Extract, Phosphatidylcholine, Glycine, Phenoxyethanol, Trideceth-6, Retinol, Hydroxyacetophenone, Lithospermum Officinale Root Extract, Phytosphingosine, Phytosterols, Propylene Carbonate, BHT, Sodium Stearoyl Glutamate, Ethylhexylglycerin, Carbomer, Xanthan Gum, Cholesterol, 1,2-Hexanediol.

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 Senmai Biotechnology Co.,Ltd.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code84509
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio8 products on file

More NDCs from Guangzhou Senmai Biotechnology Co.,Ltd. labeler code 84509

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 📋 Description 📄 Do Not Use 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 54 words ▾

Clears Acne & Bumps,Fast Flattens Acne,Fades Acne Scars,Acne Treatment.• Clears up acne pimples, blemishes, and blackheads and allows skin to heal.• Helps prevent the formation of new acne blemishes and pimples. • Clean the skin thoroughly before applying this product.• Cover the entire affected area with a thin layer one to three times daily.

⏱️ Dosage and Administration 6 words ▾

DOSAGE Approximately 0.01-0.02 oz each time.

⚠️ Warnings 46 words ▾

Do not use if you • Have very sensitive skin. • Are sensitive to benzoyl peroxide or salicylic acid. For external use only. Avoid contact with eyes。 Avoid contact with hair and dyed fabrics, including clothes, towels, and bedding, which may be bleached by benzoyl peroxide.

🧪 Active Ingredient 3 words ▾

BENZOYL PEROXIDE,Salicylic Acid

🧪 Inactive Ingredients 90 words ▾

Water, Butylene Glycol, Azelaic Acid, Niacinamide, Glycereth-26, PEG/PPG-17/6 Copolymer, Dimethicone, Squalane, Skin Lipids, Ceramide NP, Ceramide EOP, Ceramide AP, o-Cymen-5-ol, Panthenol, Zinc PCA, Lecithin, Polyglycerin-6, Allantoin, Acacia Senegal Gum, Asiaticoside, Tocopherol, Centella Asiatica Extract, Ectoin, Bisabolol, Caprylic/Capric Triglyceride, Sodium Polyacrylate, Caprylhydroxamic Acid, Fructose, Ahnfeltiopsis Concinna Extract, Sodium Lauroyl Lactylate, Ethylhexyl Stearate, Collagen, Dipotassium Glycyrrhizate, Nymphaea Alba Flower Extract, Gentiana Scabra Root Extract, Retinyl Palmitate,Dendrobium Officinale Extract, Phosphatidylcholine, Glycine, Phenoxyethanol, Trideceth-6, Retinol, Hydroxyacetophenone, Lithospermum Officinale Root Extract, Phytosphingosine, Phytosterols, Propylene Carbonate, BHT, Sodium Stearoyl Glutamate, Ethylhexylglycerin, Carbomer, Xanthan Gum, Cholesterol, 1,2-Hexanediol.

🎯 Purpose 3 words ▾

Acne Spot Treatment

📋 Description 35 words ▾

AOAO RAPID ACNE RELIEF

Guangzhou Senmai Biotechnology Co.,Ltd.

1-4/F, Building A,Guanger Intelligencelndustrial Park, No.2 Qianyi East Road, ShilingTown, Huadu District, Guangzhou, China

15ml /0.51 fl.oz.

Shelf Life ·3 Years

Place of Origin· Made in PRC

📄 Do Not Use 19 words ▾

It is recommended to test the product behind the ear before use. If discomfort is felt, do not use.

📄 When Using This Product 54 words ▾

Clears Acne & Bumps,Fast Flattens Acne,Fades Acne Scars,Acne Treatment.• Clears up acne pimples, blemishes, and blackheads and allows skin to heal.• Helps prevent the formation of new acne blemishes and pimples. • Clean the skin thoroughly before applying this product.• Cover the entire affected area with a thin layer one to three times daily.

📄 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 2 words ▾

1 A

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 Senmai Biotechnology Co.,Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guangzhou Senmai 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.
← 84509-0111-01 · Guangzhou 84509-0114-01 · 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.