Naproxen Sodium Diphenhydramine HCl 220 mg; 25 mg Tablet, Film Coated, 80-count
by CVS PHARMACY, INC · 80 TABLET, FILM COATED in 1 BOTTLE (69842-328-08)
NDC 69842-0328-08
🏷️ FDA NDC (as labeled)
69842-328-08
billing pads the product segment with a zero
This package
Contains80-count
Pack sizes2 compare ↓
Also comes in:
20 tablets 69842-0328-02
OTC
Generic
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ 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 →
⚠️
Excluded from the active FDA NDC Directory.
The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory.
Search the FDA NDC Directory ↗
🆔 Identity & classification
FDA NDC (as labeled)
69842-328-08
Product NDC
69842-328
11-digit billing NDC
69842032808
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
Discontinued
FDA listing status
Discontinued by firm
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 69842-328-08 — 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 → 69842-0328-08. 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
📖 What it is MedlinePlus · NLM
Diphenhydramine is used to treat allergy and cold symptoms: sneezing runny nose red, itchy, watery eyes itching of the nose or throat Diphenhydramine is also used to treat insomnia (difficulty falling asleep or staying asleep) in adults, but should not be used to make a child sleepy. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Diphenhydramine is also available in combination with other medications. This monograph only includes information about the use of diphenh...
Read the full MedlinePlus article ↗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.
💊 What it looks like
Color
blue
ShapeOval
ImprintG;17
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 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 0VUT3PMY82
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
-
UNII 0WZ8WG20P6
Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
-
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 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.
9 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesFD&C blue 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, 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 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:
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
| 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 69842-0328-08 | CVS | 80 tablets | — | — | Discontinued | — |
| 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 | 20 TABLET, FILM COATED in 1 BOTTLE (69842-328-02) | 2021-05-14 | Active |
| 69842-0328-08 You're viewing this | 80 TABLET, FILM COATED in 1 BOTTLE (69842-328-08) | 2021-05-14 | Discontinued by firm |
You're viewing the largest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 69842-0328-08?
NDC 69842-0328-08 is a 80-count package — 80 tablet, film coated in 1 bottle.
What is the difference between NDC 69842-0328-08 and NDC 69842-0328-02?
Both are Naproxen Sodium Diphenhydramine HCl 220 mg; 25 mg Tablet, Film Coated — the drug itself is identical. NDC 69842-0328-08 is the 80-count package, while NDC 69842-0328-02 is the 20 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 69842-0328-08 — the 11-digit billing format is 69842032808. 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
No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 69842-328-08, 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: 69842-0328-08, written without dashes as 69842032808. 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 69842-0328-08, 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 (08) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 20 tablets (69842-0328-02). 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.