Naproxen Sodium Diphenhydramine HCl 220 mg; 25 mg Tablet, Film Coated, 20-count
by CVS PHARMACY, INC · 20 TABLET, FILM COATED in 1 BOTTLE (69842-328-02)
NDC 69842-0328-02
🏷️ FDA NDC (as labeled)
69842-328-02
billing pads the product segment with a zero
This package
Contains20-count
Pack sizes2 compare ↓
Also comes in:
80 tablets 69842-0328-08
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 →
🆔 Identity & classification
FDA NDC (as labeled)
69842-328-02
Product NDC
69842-328
11-digit billing NDC
69842032802
RxCUI
1550957
UNII
9TN87S3A3C, TC2D6JAD40
Application #
ANDA213663
SPL Set ID
bdac694e-ab2a-376d-e053-2a95a90a9467
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
2021-05-14
Route
ORAL
Dosage form
TABLET, FILM COATED
Substance
NAPROXEN SODIUM; DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 69842-328-02 — 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 → 69842-0328-02. 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
LabelerCVS PHARMACY, INC
Application holderGRANULES INDIA LTD
FDA applicationANDA213663 (ANDA)
Labeler code69842
First marketedMay 2021
Product typeHuman Otc Drug
Portfolio102 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
Patient education
Supplement & herbal interactions
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.
💬 Questions about Naproxen Sodium Diphenhydramine HCl?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 system | Per each | Per 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:
80 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| good sense naproxen sodium 25 mg/1; 220 mg 00113-8264-58 | L. | 40 tablets | — | — | Discontinued | — |
| 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 | — | — | 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 mgthis 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
🏛️
2021
On the market since
May 2021
📍
2026
Currently FDA-listed
5 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69842-0328-02 You're viewing this | 20 TABLET, FILM COATED in 1 BOTTLE (69842-328-02) | 2021-05-14 | Active |
| 69842-0328-08 | 80 TABLET, FILM COATED in 1 BOTTLE (69842-328-08) | 2021-05-14 | Discontinued by firm |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 69842-0328-02?
NDC 69842-0328-02 is a 20-count package — 20 tablet, film coated in 1 bottle.
What is the difference between NDC 69842-0328-02 and NDC 69842-0328-08?
Both are Naproxen Sodium Diphenhydramine HCl 220 mg; 25 mg Tablet, Film Coated — the drug itself is identical. NDC 69842-0328-02 is the 20-count package, while NDC 69842-0328-08 is the 80 tablets package.
What NDC number is used to bill for this package of Naproxen Sodium Diphenhydramine HCl 220 mg; 25 mg Tablet, Film Coated?
Bill NDC 69842-0328-02 — the 11-digit billing format is 69842032802. 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 | — Not published for this NDC No photo available yet for this listing. |
| 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 69842-328-02, 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: 69842-0328-02, written without dashes as 69842032802. 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 69842-0328-02, the first segment (69842) is the labeler code FDA assigned to CVS PHARMACY, INC; the middle segment (0328) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 CVS PHARMACY, INC. 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 80 tablets (69842-0328-08). 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?
CVS PHARMACY, INC 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 and Cautions
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses • for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep
⏱️ Dosage and Administration ▾
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 and Cautions ▾
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 use more than directed or for longer than directed.
⚠️ 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.
🧪 Active Ingredient ▾
Active ingredients (in each caplet) Diphenhydramine Hydrochloride 25 mg Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*
🧪 Inactive Ingredients ▾
Inactive ingredients FD&C blue 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.
🎯 Purpose ▾
Purposes Nighttime sleep aid Pain reliever
No label section mentions that — try another word, or open the full label on DailyMed below.
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.