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Motrin PM Ibuprofen and Diphenhydramine Citrate 200 mg; 38 mg Tablet, Coated, 80-count — NDC 50580-0563-80 package photo

Motrin PM Ibuprofen and Diphenhydramine Citrate 200 mg; 38 mg Tablet, Coated, 80-count

by Kenvue Brands LLC · 1 BOTTLE, PLASTIC in 1 CARTON (50580-563-80) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC
NDC 50580-0563-80
🏷️ FDA NDC (as labeled) 50580-563-80 billing pads the product segment with a zero
This package
Contains80-count Pack sizes2 compare ↓
Also comes in: 20 tablets 50580-0563-20
OTC Generic On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 50580-563-80
Product NDC 50580-563
11-digit billing NDC 50580056380
NCPDP billing unit EA — each (per item)
RxCUI 895664, 895666
UNII WK2XYI10QM, 4OD433S209
UPC 0300450563804
Application # ANDA079113
SPL Set ID 55403f19-58ae-450b-8a7b-0bc544088f20
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-01-11
Route ORAL
Dosage form TABLET, COATED
Substance IBUPROFEN; DIPHENHYDRAMINE CITRATE
GCN Seq No 062493
GCN 98268
HICL code 034634
Ingredient (HICL) Ibuprofen/Diphenhydramine Cit
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S2
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints
HIC3 code S2S
Therapeutic class — specific (HIC3) Analgesic,Nsaid-1St Gen.antihistamine,Sedative Cmb
AHFS code 04:04.04.00
AHFS class Ethanolamine Derivatives
FDB label name MOTRIN PM CAPLET
FDB brand name Motrin Pm
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 50580-563-80 — 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 → 50580-0563-80. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works Histamine H1 Receptor Antagonists
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.

🏭 Manufacturer & labeler

LabelerKenvue Brands LLC
Application holderPERRIGO R AND D CO
FDA applicationANDA079113 (ANDA)
Labeler code50580
First marketedJan 2010
Product typeHuman Otc Drug
Portfolio567 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

Label name MOTRIN PM CAPLET Ingredient Ibuprofen/Diphenhydramine Cit
📗 Our plain-language guide HelloPharmacist
  • No — this product is specifically for nights when you have both minor pain AND trouble sleeping at the same time. It's not meant to be used as a plain sleep aid. If you're struggli...
  • What exactly is this medicine for — can I just take it to help me sleep?
  • Take 2 capsules or caplets at bedtime — whichever form your product comes in. Don't take more than that in 24 hours. If it bothers your stomach, go ahead and take it with food or a...
  • How do I take it, and is it okay to take with food?
📖 Read our full Diphenhydramine / Ibuprofen 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.

💊 What it looks like

Color white
ShapeOval
ImprintMOTRIN;PM
Size15 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 20 tablets
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
good neighbor pharmacy ibuprofen pm 38 mg/1; 200 mg 46122-0708-41 Amerisource 80 tablets $0.122 — Discontinued —
Leader Ibuprofen PM 38 mg/1; 200 mg 70000-0157-01 Cardinal 40 tablets $0.125 — FDA listed —
good sense ibuprofen pm 38 mg/1; 200 mg 00113-0050-58 L. 40 tablets $0.131 — Availability likely —
foster and thrive ibuprofen pm 38 mg/1; 200 mg 70677-1131-01 Strategic 40 tablets $0.131 — Availability likely —
Ibuprofen PM 38 mg/1; 200 mg 00363-0050-27 Walgreen 80 tablets — — FDA listed —
Advil Pm 38 mg/1; 200 mg 00573-0164-04 Haleon 4 tablets — — FDA listed —
up and up ibuprofen pm 38 mg/1; 200 mg 11673-0050-58 Target 40 tablets — — FDA listed —
ibuprofen pm 38 mg/1; 200 mg 11822-0050-01 Rite 80 tablets — — Discontinued —
Ibuprofen PM 200 mg/1; 38 mg 21130-0056-40 Safeway, 40 tablets — — FDA listed —
Ibuprofen and Diphenhydramine Citrate 200 mg/1; 38 mg 21130-0228-12 Better 40 tablets — — FDA listed —
Signature Care Ibuprofen PM 38 mg/1; 200 mg 21130-0283-27 Safeway 80 tablets — — Discontinued —
Ibuprofen Pm 38 mg/1; 200 mg 21130-0623-76 Safeway 120 tablets — — FDA listed —
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated 38 mg/1; 200 mg 29485-6533-04 Lil 2 tablets — — FDA listed —
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated 38 mg/1; 200 mg 29485-7008-03 Lil 2 tablets — — FDA listed —
ibuprofen pm 38 mg/1; 200 mg 30142-0050-27 Kroger 80 tablets — — FDA listed —
Ibuprofen PM 200 mg/1; 38 mg 30142-0278-80 KROGER 80 tablets — — FDA listed —
Topcare Ibuprofen PM 38 mg/1; 200 mg 36800-0050-27 Topco 80 tablets — — FDA listed —
ibuprofen pm 38 mg/1; 200 mg 37808-0703-60 H 20 tablets — — FDA listed —
equaline ibuprofen pm 38 mg/1; 200 mg 41163-0050-27 United 80 tablets — — FDA listed —
Ibuprofen PM 38 mg/1; 200 mg 41250-0050-27 Meijer 80 tablets — — Discontinued —
Care One Ibuprofen PM 38 mg/1; 200 mg 41520-0050-27 American 80 tablets — — FDA listed —
ibuprofen pm 38 mg/1; 200 mg 42507-0050-27 HyVee 80 tablets — — FDA listed —
equate ibuprofen pm 38 mg/1; 200 mg 49035-0699-27 Wal-Mart 80 tablets — — FDA listed —
Motrin PM 200 mg/1; 38 mgthis 50580-0563-80 Kenvue 80 tablets — — FDA listed —
Ibuprofen and Diphenhydramine Citrate 200 mg/1; 38 mg 55111-0565-05 Dr. 500 tablets — — FDA listed —
Exchange Select Ibuprofen PM 38 mg/1; 200 mg 55301-0050-60 Army 20 tablets — — FDA listed —
Ibuprofen PM 200 mg/1; 38 mg 55319-0197-20 Family 20 tablets — — FDA listed —
dg health Ibuprofen pm 38 mg/1; 200 mg 55910-0050-27 Dolgencorp 80 tablets — — FDA listed —
Ibuprofen and Diphenhydramine Citrate 200 mg/1; 38 mg 58602-0867-09 Aurohealth 30 tablets — — FDA listed —
ibuprofen pm 38 mg/1; 200 mg 59779-0050-27 CVS 80 tablets — — FDA listed —
Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg 200 mg/1; 38 mg 63548-0197-02 PLD 20 tablets — — FDA listed —
Advil PM, TRAVEL BASIX 200 mg/1; 38 mg 66715-6433-02 Lil' 2 tablets — — FDA listed —
Advil PM, CVP HEALTH 200 mg/1; 38 mg 66715-6533-02 Lil' 2 tablets — — FDA listed —
Advil PM 200 mg/1; 38 mg 66715-9633-03 Lil' 2 tablets — — FDA listed —
Advil PM 200 mg/1; 38 mg 66715-9733-02 Lil' 2 tablets — — FDA listed —
Advil PM 38 mg/1; 200 mg 67751-0147-01 Navajo 2 tablets — — FDA listed —
Ibuprofen PM 200 mg/1; 38 mg 69607-1970-01 WR 120 tablets — — FDA listed —
basic care ibuprofen pm 38 mg/1; 200 mg 72288-0050-60 Amazon.com 20 tablets — — FDA listed —
Amazon Basic Care Ibuprofen Pm 200 mg/1; 38 mg 72288-0061-77 Amazon.com 120 tablets — — FDA listed —
Ibuprofen PM 200 mg/1; 38 mg 79903-0186-20 WALMART 20 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2010
On the market since
Jan 2010
📍
2026
Currently FDA-listed
16 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Motrin PM (this brand).

Top reported reactions

Pain1,884
Nausea1,689
Headache1,614
Fatigue1,231
Dizziness1,047
Anxiety1,020
Drug Hypersensitivity1,019

Reporter sex

18,662 reports
Male · 28%
Female · 72%
Unknown · 1%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,193 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50580-0563-20 1 BOTTLE, PLASTIC in 1 CARTON (50580-563-20) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC 2010-01-11 Active
50580-0563-80 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (50580-563-80) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC 2010-01-11 Active

Pack size FAQ

What quantity is in NDC 50580-0563-80?
NDC 50580-0563-80 is a 80-count package — 1 bottle, plastic in 1 carton / 80 tablet, coated in 1 bottle, plastic.
What is the difference between NDC 50580-0563-80 and NDC 50580-0563-20?
Both are Motrin PM Ibuprofen and Diphenhydramine Citrate 200 mg; 38 mg Tablet, Coated — the drug itself is identical. NDC 50580-0563-80 is the 80-count package, while NDC 50580-0563-20 is the 20 tablets package.
What NDC number is used to bill for this package of Motrin PM Ibuprofen and Diphenhydramine Citrate 200 mg; 38 mg Tablet, Coated?
Bill NDC 50580-0563-80 — the 11-digit billing format is 50580056380. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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

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 50580-563-80, 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: 50580-0563-80, written without dashes as 50580056380. 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 50580-0563-80, the first segment (50580) is the labeler code FDA assigned to Kenvue Brands LLC; the middle segment (0563) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (80) 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 Kenvue Brands LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 20 tablets (50580-0563-20). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Kenvue Brands LLC 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 20 words ▾

Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep

⏱️ Dosage and Administration 29 words ▾

Directions do not take more than directed adults and children 12 years and over: take 2 caplets at bedtime do not take more than 2 caplets in 24 hours

⚠️ Warnings ~2 min read ▾

Warnings Allergy alert Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer unless you have time for a full night's sleep in children under 12 years of age right before or after heart surgery with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you have a breathing problem such as emphysema or chronic bronchitis you have glaucoma you have trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers, or any other sleep-aid under a doctor's care for any continuing medical illness taking any other antihistamines taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days sleeplessness persists continuously for more than 2 weeks.

Insomnia may be a symptom of a serious underlying medical illness. redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

📦 Storage and Handling 21 words ▾

Other information read all warnings and directions before use. Keep carton. store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

🧪 Active Ingredient 21 words ▾

Active ingredients (in each caplet) Purposes Diphenhydramine citrate 38 mg Nighttime sleep-aid Ibuprofen 200 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, glyceryl behenate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

🎯 Purpose 21 words ▾

Active ingredients (in each caplet) Purposes Diphenhydramine citrate 38 mg Nighttime sleep-aid Ibuprofen 200 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50580-0555-04 · Kenvue 50580-0566-25 · Kenvue →
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.