Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM 25 mg; 220 mg Tablet, Film Coated, 160-count — NDC 00280-1200-03 package photo

Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM 25 mg; 220 mg Tablet, Film Coated, 160-count

by Bayer HealthCare LLC. · 160 TABLET, FILM COATED in 1 BOTTLE (0280-1200-03)
NDC 00280-1200-03
🏷️ FDA NDC (as labeled) 0280-1200-03 billing pads the labeler segment with a zero
This package
Contains160-count Pack sizes9 compare ↓
OTC Brand 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) 0280-1200-03
Product NDC 0280-1200
11-digit billing NDC 00280120003
RxCUI 1550957, 1550963
UNII TC2D6JAD40, 9TN87S3A3C
UPC 0025866591882
Application # NDA205352
SPL Set ID 82891458-ab0d-459a-8602-dcebd22c3010
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 NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-09-09
Route ORAL
Dosage form TABLET, FILM COATED
Substance DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Why two NDCs? The FDA registers this code as 0280-1200-03 — 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 → 00280-1200-03. 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

LabelerBayer HealthCare LLC.
Application holderBAYER HEALTHCARE CONSUMER CARE
FDA applicationNDA205352 (NDA)
Labeler code00280
First marketedSep 2014
Product typeHuman Otc Drug
Portfolio240 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

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
ImprintALEVE;PM
Size14 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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • 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 L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 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 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 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.
  • 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.

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

The official label also statescarnauba wax, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, 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 DailyMedingredient 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.
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 mg 00113-8264-58 L. 40 tablets Discontinued
Aleve PM 25 mg/1; 220 mgthis 00280-1200-03 Bayer 160 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 Discontinued
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 the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2014
On the market since
Sep 2014
📍
2026
Currently FDA-listed
12 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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
00280-1200-01 1 BOTTLE in 1 CARTON (0280-1200-01) / 120 TABLET, FILM COATED in 1 BOTTLE 2014-09-09 Active
00280-1200-02 2 TABLET, FILM COATED in 1 POUCH (0280-1200-02) 2014-09-09 Active
00280-1200-03 You're viewing this 160 TABLET, FILM COATED in 1 BOTTLE (0280-1200-03) 2014-09-09 Active
00280-1200-04 1 BOTTLE in 1 CARTON (0280-1200-04) / 40 TABLET, FILM COATED in 1 BOTTLE 2014-09-09 Active
00280-1200-05 80 TABLET, FILM COATED in 1 BOTTLE (0280-1200-05) 2014-09-09 Active
00280-1200-08 1 BOTTLE in 1 CARTON (0280-1200-08) / 250 TABLET, FILM COATED in 1 BOTTLE 2021-07-01 Active
00280-1200-20 1 BOTTLE in 1 CARTON (0280-1200-20) / 20 TABLET, FILM COATED in 1 BOTTLE 2014-09-09 Active
00280-1200-40 1 BOTTLE in 1 CARTON (0280-1200-40) / 40 TABLET, FILM COATED in 1 BOTTLE 2014-09-09 Active
00280-1200-80 1 BOTTLE in 1 CARTON (0280-1200-80) / 80 TABLET, FILM COATED in 1 BOTTLE 2014-09-09 Active

Pack size FAQ

What quantity is in NDC 00280-1200-03?
NDC 00280-1200-03 is a 160-count package — 160 tablet, film coated in 1 bottle.
What is the difference between NDC 00280-1200-03 and NDC 00280-1200-02?
Both are Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM 25 mg; 220 mg Tablet, Film Coated — the drug itself is identical. NDC 00280-1200-03 is the 160-count package, while NDC 00280-1200-02 is the 2 tablets package.
What NDC number is used to bill for this package of Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM 25 mg; 220 mg Tablet, Film Coated?
Bill NDC 00280-1200-03 — the 11-digit billing format is 00280120003. 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 0280-1200-03, 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: 00280-1200-03, written without dashes as 00280120003. 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 00280-1200-03, the first segment (00280) is the labeler code FDA assigned to Bayer HealthCare LLC.; the middle segment (1200) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Bayer HealthCare 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 8 other package presentations of this same product, including 2 tablets (00280-1200-02), 20 tablets (00280-1200-20), 40 tablets (00280-1200-04). 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?
Bayer HealthCare 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 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 49 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 ~2 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 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.

📦 Storage and Handling 31 words

Other information read all warnings and directions before use. Keep outer carton. each caplet contains: sodium 20 mg store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F)

🧪 Active Ingredient 25 words

Active ingredients (in each caplet) Purposes Diphenhydramine hydrochloride 25 mg Nighttime sleep-aid Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) nonsteroidal anti-inflammatory drug Pain reliever

🧪 Inactive Ingredients 22 words

Inactive ingredients carnauba wax, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, titanium dioxide

🎯 Purpose 25 words

Active ingredients (in each caplet) Purposes Diphenhydramine hydrochloride 25 mg Nighttime sleep-aid Naproxen sodium 220 mg (naproxen 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 ↗
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.