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Atti amour Rose Anti-Aging Repair Moisturizing Cream NIACINAMIDE, GLYCERIN 10 g/100g; 4.725 g/100g Cream, 50 g

by RIVER SUNZ co.,Ltd · 50 g in 1 BOTTLE (84601-004-01)
NDC 84601-0004-01
🏷️ FDA NDC (as labeled) 84601-004-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 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) 84601-004-01
Product NDC 84601-004
11-digit billing NDC 84601000401
UNII PDC6A3C0OX, 25X51I8RD4
Application # M016
SPL Set ID 1eec4cfe-d5a3-3570-e063-6294a90ac38b
Established class (EPC) Non-Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class Allergens; Glycerol
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-08-05
Route TOPICAL
Dosage form CREAM
Substance GLYCERIN; NIACINAMIDE
Why two NDCs? The FDA registers this code as 84601-004-01 — 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 → 84601-0004-01. 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.

🏭 Manufacturer & labeler

LabelerRIVER SUNZ co.,Ltd
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code84601
First marketedAug 2024
Product typeHuman Otc Drug
Portfolio4 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.

🩺 Clinical

🧪 What is this product?

Atti Amour Rose Anti-Aging Repair Moisturizing Cream is a topical moisturizer that contains niacinamide and glycerin as active ingredients. Glycerin is a humectant commonly used in skincare to help draw moisture into and retain hydration in the skin. Niacinamide (a form of vitamin B3) is typically included in moisturizers and cosmetic creams for its role in skin conditioning. This is an over-the-counter monograph product, meaning it is marketed under FDA's established guidelines for this class of moisturizing creams.

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 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 L4EL31FWIL
    A synthetic peptide (short chain of amino acids) used as a conditioning or texture-enhancing agent in topical formulations. It helps improve product feel and skin compatibility in creams and lotions.
  • 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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII NP9U26B839
    A form of carbon consisting of 60 atoms arranged in a sphere-like structure. It may be used as an antioxidant to help protect the medicine from degradation during storage.
  • 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 SF3LP91341
    A waxy, skin-like lipid that helps form protective barriers in creams and lotions. It's used as an emollient and skin-conditioning agent to improve texture and help the product spread smoothly.
  • 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 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 H895X08VNQ
    A silicone-based polymer that forms small, hard particles. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
  • UNII SA6A6V432S
    Dimethyl isosorbide is a clear liquid solvent derived from natural sugar sources. It helps dissolve active ingredients and improve their absorption in liquid medicines and topical products.
  • UNII 38H206R00R
    A synthetic compound used as a skin-conditioning agent and preservative booster in topical formulations. It helps maintain product stability and may enhance the skin feel of creams or lotions.
  • 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 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • 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 EB41QIU6JL
    Farnesol is a natural fragrant compound found in plants. It's used in medicines as a preservative and flavoring agent to improve taste and help prevent microbial growth.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII J2S07SB0YL
    A protein derived from wheat that has been broken down into smaller pieces using enzymes. It's used in formulations as a film-former and texturizer to help bind ingredients together and improve product 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 4U3GMG1OT1
    A humectant and skin-conditioning agent derived from cellulose or similar plant sources. It helps retain moisture in the formulation and may improve texture or spreadability in topical products.
  • UNII 3K209OP33H
    A beneficial bacterium added to support gut health and digestion. It acts as a probiotic, helping maintain healthy intestinal bacteria balance in the product formulation.
  • 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 AHG15J8AM0
    A plant extract from the white lily bulb used in traditional formulations. It may serve as a skin-conditioning agent or natural ingredient to support texture and consistency in topical or oral products.
  • UNII 515610SU8C
    Macadamia oil is a plant-derived oil extracted from macadamia nuts. In medicines, it serves as an emollient and solvent to help dissolve or suspend active ingredients and improve product texture and absorption.
  • 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 KQX236OK4U
    A fine powder made from the outer layer of oat grain. It acts as a filler and binder to give the medicine its form and texture, and may also help the tablet or capsule break down properly in the digestive system.
  • UNII 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII GIN46U9Q2Q
    Phytosphingosine is a naturally derived fatty compound that helps stabilize and thicken skincare and cosmetic formulations. It works as an emollient and conditioning agent to improve texture and skin feel in topical products.
  • UNII 598RES7AXX
    A synthetic emulsifier derived from glycerin and oleic acid. It helps mix oil and water components in formulations, improving texture and stability of creams, lotions, or suspensions.
  • UNII Q48X4BL3TV
    A synthetic emulsifier made from plant-derived glycerin and lauric acid. It helps blend oil and water-based ingredients together in creams and lotions for smooth, uniform texture.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 18920M3T13
    Rosa damascena flower oil is a fragrant plant oil extracted from damask rose petals. It's used in medicines as a flavoring and aromatic agent to improve taste and scent.
  • UNII 8M1P49MWAP
    A plant oil extracted from wild rose seeds. It serves as an emollient and skin-conditioning agent in topical medicines, helping soften and moisturize the product's texture.
  • UNII 969IQC5YJU
    A natural plant extract from the rugosa rose flower. It's used in formulations as a fragrance, flavor, or natural colorant to improve the taste, smell, or appearance of the medicine.
  • 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 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 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 TE719OVG2P
    A plant-derived oil ester used as an emollient and skin-conditioning agent in topical medicines. It helps soften the product texture and improves how the medicine spreads on and absorbs into skin.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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.

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

The official label also statesFULLERENES ECTOIN ROSA DAMASCENA FLOWER WATER HYDROXYACETOPHENONE 1,2-HEXANEDIOL LILIUM CANDIDUM BULB EXTRACT MACADAMIA TERNIFOLIA SEED OIL ETHYLHEXYL PALMITATE BUTYLENE GLYCOL CAPRYLIC/CAPRIC TRIGLYCERIDE DIMETHICONE POLYGLYCERYL-6 LAURATE TOCOPHERYL ACETATE TRIETHANOLAMINE ROSA RUBIGINOSA SEED OIL ROSA DAMASCENA FLOWER OIL BISABOLOL FARNESOL PENTYLENE GLYCOL AVENA SATIVA (OAT) BRAN EXTRACT HYDROXYPROPYL TETRAHYDROPYRANTRIOL OLIGOPEPTIDE-1 OLIGOPEPTIDE-5 OLIGOPEPTIDE-2 LACTOBACILLUS FERMENT LACTOBACILLUS FERMENT LYSATE ROSA RUGOSA FLOWER EXTRACT COLLAGEN HYALURONIC ACID DECAPEPTIDE-4 GLYCOPROTEINS DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE ACETYL HEXAPEPTIDE-8 DIMETHYL ISOSORBIDE CERAMIDE EOP CERAMIDE NP CERAMIDE AS CERAMIDE AP PHYTOSPHINGOSINE CHOLESTEROL SQUALANE PHYTOSTEROLS PHYTOSTERYL OLEATE PVP GLYCERYL STEARATE PEG-100 STEARATE DISODIUM PHOSPHATE SODIUM CHLORIDE ETHYLHEXYLGLYCERIN OCTYLDODECANOL WATER POLYGLYCERYL-10 DIOLEATE

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atti amour Rose Anti-Aging Repair Moisturizing Cream 10 g/100g; 4.725 g/100gthis 84601-0004-01 RIVER 50 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

🏛️
2024
On the market since
Aug 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84601-0004-01 You're viewing this 50 g in 1 BOTTLE (84601-004-01) 2024-08-05 Active

🧭 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 FDA registers it as 84601-004-01, 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: 84601-0004-01, written without dashes as 84601000401. 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 84601-0004-01, the first segment (84601) is the labeler code FDA assigned to RIVER SUNZ co.,Ltd; the middle segment (0004) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 RIVER SUNZ co.,Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
RIVER SUNZ 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 9 words ▾

Uses Helps with skin whitening and wrinkle improve ment.

⏱️ Dosage and Administration 14 words ▾

Take an appropriate amount of ointment and apply it evenly to the desired area

⚠️ Warnings 60 words ▾

When using this product Refrain from using on wounds or damaged areas.Stop use and ask a doctor if many abnormal symptoms or side effects, such as redness.swelling, or itching,occur in the area of application during or after using the cosmeticproduct. Keep out of reach of children if swallowed , get medical help or contact a Poison Control Center night away.

🧪 Active Ingredient 4 words ▾

NIACINAMIDE 4.725% GLYCERIN 10%

🧪 Inactive Ingredients 100 words ▾

FULLERENES ECTOIN ROSA DAMASCENA FLOWER WATER HYDROXYACETOPHENONE 1,2-HEXANEDIOL LILIUM CANDIDUM BULB EXTRACT MACADAMIA TERNIFOLIA SEED OIL ETHYLHEXYL PALMITATE BUTYLENE GLYCOL CAPRYLIC/CAPRIC TRIGLYCERIDE DIMETHICONE POLYGLYCERYL-6 LAURATE TOCOPHERYL ACETATE TRIETHANOLAMINE ROSA RUBIGINOSA SEED OIL ROSA DAMASCENA FLOWER OIL BISABOLOL FARNESOL PENTYLENE GLYCOL AVENA SATIVA (OAT) BRAN EXTRACT HYDROXYPROPYL TETRAHYDROPYRANTRIOL OLIGOPEPTIDE-1 OLIGOPEPTIDE-5 OLIGOPEPTIDE-2 LACTOBACILLUS FERMENT LACTOBACILLUS FERMENT LYSATE ROSA RUGOSA FLOWER EXTRACT COLLAGEN HYALURONIC ACID DECAPEPTIDE-4 GLYCOPROTEINS DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE ACETYL HEXAPEPTIDE-8 DIMETHYL ISOSORBIDE CERAMIDE EOP CERAMIDE NP CERAMIDE AS CERAMIDE AP PHYTOSPHINGOSINE CHOLESTEROL SQUALANE PHYTOSTEROLS PHYTOSTERYL OLEATE PVP GLYCERYL STEARATE PEG-100 STEARATE DISODIUM PHOSPHATE SODIUM CHLORIDE ETHYLHEXYLGLYCERIN OCTYLDODECANOL WATER POLYGLYCERYL-10 DIOLEATE

🎯 Purpose 8 words ▾

Helps with skin whitening and wrinkle improve ment.

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.