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good sense naproxen sodium diphenhydramine hydrochloride, 25 mg; 220 mg Tablet, Film Coated, 50-count — NDC 00113-8264-71 package photo

good sense naproxen sodium diphenhydramine hydrochloride, 25 mg; 220 mg Tablet, Film Coated, 50-count

by L. Perrigo Company · 1 BOTTLE in 1 CARTON (0113-8264-71) / 50 TABLET, FILM COATED in 1 BOTTLE
NDC 00113-8264-71
🏷️ FDA NDC (as labeled) 0113-8264-71 billing pads the labeler segment with a zero
This package
Contains50-count Pack sizes4 compare ↓
Also comes in: 20 tablets 00113-8264-60 40 tablets 00113-8264-58 160 tablets 00113-8264-06
OTC Generic 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 →

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) 0113-8264-71
Product NDC 0113-8264
11-digit billing NDC 00113826471
NCPDP billing unit EA — each (per item)
RxCUI 1550957
UNII TC2D6JAD40, 9TN87S3A3C
Application # ANDA208499
SPL Set ID f548aa3d-b35e-458a-9815-3595a451ab78
Established class (EPC) Anti-Inflammatory Agents; Histamine-1 Receptor Antagonist; Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors; Histamine H1 Receptor Antagonists
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-12-28
Route ORAL
Dosage form TABLET, FILM COATED
Substance DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Why two NDCs? The FDA registers this code as 0113-8264-71 — a 4-4-2 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 labeler segment → 00113-8264-71. 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

LabelerL. Perrigo Company
Application holderPERRIGO R AND D CO
FDA applicationANDA208499 (ANDA)
Labeler code00113
First marketedDec 2018
Product typeHuman Otc Drug
Portfolio227 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

1
Nutrient depletion considerations

Diphenhydramine Hydrochloride, Naproxen Sodium may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Diphenhydramine Hydrochloride, Naproxen Sodium nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 Blue
ShapeOval
ImprintL264
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
  • UNII 4AQJ3LG584
    A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statescroscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

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 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 40 tablets 160 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 sense naproxen sodium 25 mg/1; 220 mgthis 00113-8264-71 L. 50 tablets — — FDA listed —
Aleve PM 25 mg/1; 220 mg 00280-1200-01 Bayer 120 tablets — — FDA listed —
All Night Pain Relief Pm 25 mg/1; 220 mg 00363-2264-27 Walgreen 80 tablets — — FDA listed —
up and up naproxen sodium pm 25 mg/1; 220 mg 11673-0687-27 Target 80 tablets — — FDA listed —
Naproxen Sodium and Diphenhydramine HCL 25 mg/1; 220 mg 11673-0819-08 TARGET 80 tablets — — FDA listed —
Naproxen Sodium Pm 25 mg/1; 220 mg 21130-0639-71 Safeway 50 tablets — — FDA listed —
Naproxen Sodium Diphenhydramine Hydrochloride 220 mg/1; 25 mg 21130-0814-05 SAFEWAY 50 tablets — — FDA listed —
naproxen sodium pm 25 mg/1; 220 mg 30142-0383-60 Kroger 20 tablets — — Discontinued —
naproxen sodium pm 25 mg/1; 220 mg 30142-0753-27 Kroger 80 tablets — — FDA listed —
topcare all night pain relief pm 25 mg/1; 220 mg 36800-0264-27 Topco 80 tablets — — FDA listed —
naproxen sodium pm 25 mg/1; 220 mg 37808-0264-27 H 80 tablets — — FDA listed —
equaline naproxen sodium pm 25 mg/1; 220 mg 41163-0593-58 United 40 tablets — — Discontinued —
naproxen sodium pm 25 mg/1; 220 mg 41250-0526-27 Meijer 80 tablets — — FDA listed —
careone naproxen sodium pm 25 mg/1; 220 mg 41520-0264-27 American 80 tablets — — FDA listed —
dg health naproxen sodium pm 25 mg/1; 220 mg 55910-0858-27 Dolgencorp 80 tablets — — FDA listed —
Naproxen Sodium PM 220 mg/1; 25 mg 62011-0396-01 Strategic 20 tablets — — FDA listed —
Naproxen Sodium and Diphenhydramine HCl 220 mg/1; 25 mg 62207-0814-38 Granules 37500 tablets — — FDA listed —
Naproxen Sodium and Diphenhydramine HCl 220 mg/1; 25 mg 69238-1422-02 Amneal 20 tablets — — FDA listed —
Naproxen Sodium Diphenhydramine HCl 220 mg/1; 25 mg 69842-0328-02 CVS 20 tablets — — FDA listed —
Naproxen Sodium PM 220 mg/1; 25 mg 70677-0064-01 Strategic 20 tablets — — FDA listed —
basic care naproxen sodium pm 25 mg/1; 220 mg 72288-0310-06 Amazon.com 160 tablets — — FDA listed —
Naproxen Sodium Diphenhydramine HCL 25 mg/1; 220 mg 79903-0204-20 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

🏛️
2018
On the market since
Dec 2018
📍
2026
Currently FDA-listed
8 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 good sense naproxen sodium (this brand).

Top reported reactions

Fatigue2,689
Pain2,535
Rash2,331
Arthralgia2,262
Diarrhoea2,259
Vomiting2,206
Condition Aggravated2,153

Age at onset

Neonate52
Infant2
Child48
Adolescent53
Adult1,950
Elderly459

Reporter sex

13,461 reports
Male · 22%
Female · 77%
Unknown · 0%

Serious outcomes

Hospitalization5,871
Life-threatening3,847
Disabling3,796
Death3,768
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,056 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
00113-8264-58 1 BOTTLE in 1 CARTON (0113-8264-58) / 40 TABLET, FILM COATED in 1 BOTTLE 2019-06-06 Discontinued by firm
00113-8264-60 1 BOTTLE in 1 CARTON (0113-8264-60) / 20 TABLET, FILM COATED in 1 BOTTLE 2018-12-28 Active
00113-8264-71 You're viewing this 1 BOTTLE in 1 CARTON (0113-8264-71) / 50 TABLET, FILM COATED in 1 BOTTLE 2022-03-14 Active
00113-8264-06 1 BOTTLE in 1 CARTON (0113-8264-06) / 160 TABLET, FILM COATED in 1 BOTTLE (0113-8264-00) 2026-02-26 Active

Pack size FAQ

What quantity is in NDC 00113-8264-71?
NDC 00113-8264-71 is a 50-count package — 1 bottle in 1 carton / 50 tablet, film coated in 1 bottle.
What is the difference between NDC 00113-8264-71 and NDC 00113-8264-60?
Both are good sense naproxen sodium diphenhydramine hydrochloride, 25 mg; 220 mg Tablet, Film Coated — the drug itself is identical. NDC 00113-8264-71 is the 50-count package, while NDC 00113-8264-60 is the 20 tablets package.
What NDC number is used to bill for this package of good sense naproxen sodium diphenhydramine hydrochloride, 25 mg; 220 mg Tablet, Film Coated?
Bill NDC 00113-8264-71 — the 11-digit billing format is 00113826471. 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) ✓ 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 0113-8264-71, 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: 00113-8264-71, written without dashes as 00113826471. 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 00113-8264-71, the first segment (00113) is the labeler code FDA assigned to L. Perrigo Company; the middle segment (8264) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (71) 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 L. Perrigo Company. 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 3 other package presentations of this same product, including 20 tablets (00113-8264-60), 40 tablets (00113-8264-58), 160 tablets (00113-8264-06). 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?
L. Perrigo Company 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 22 words ▾

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

⏱️ Dosage and Administration 54 words ▾

Directions • do not take more than directed • drink a full glass of water with each dose • adults and children 12 years and over: take 2 caplets at bedtime • do not take more than 2 caplets in 24 hours • if taken with food, this product may take longer to work

⚠️ Warnings ~3 min read ▾

Warnings Allergy alert: Naproxen sodium 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 serious condition • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin • taking any other antihistamines • 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 • you have difficulty swallowing • it feels like the pill is stuck in your throat If pregnant or breast feeding ask a health professional before use. It is especially important not to use naproxen sodium 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).

🧪 Active Ingredient 20 words ▾

Active ingredients (in each caplet) Diphenhydramine hydrochloride 25 mg Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 28 words ▾

Inactive ingredients croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

🎯 Purpose 5 words ▾

Purposes Nighttime sleep-aid Pain reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00113-8175-01 · L. 00113-8307-68 · L. →
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.