Naproxen Sodium Diphenhydramine HCl

Manufacturer
CVS PHARMACY, INC
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:27:23

Label at a glance#

ProductNaproxen Sodium Diphenhydramine HCl
Active ingredientNAPROXEN SODIUM, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure18 sections

Indications and uses

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

Dosage and administration

• 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

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 25 mg

Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*

Purposes

OTC - PURPOSE SECTION

Nighttime sleep aid

Pain reliever

Uses

INDICATIONS & USAGE SECTION

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

Allergy alert

WARNINGS SECTION

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

WARNINGS AND PRECAUTIONS SECTION

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

WARNINGS AND PRECAUTIONS SECTION

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.

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

• 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

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

Contact 1-877-770-3183
Mon-Fri 8:00 AM EST to 5:00 PM PST.

Naproxen Sodium & Diphenhydramine HCl 220mg/25mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1550957diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral TabletPSN7
1550957diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral TabletSCD7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
NAPROXEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-328-02Naproxen Sodium Diphenhydramine HCl20 in 1 BOTTLETABLET, FILM COATED207
69842-328-08Naproxen Sodium Diphenhydramine HCl80 in 1 BOTTLETABLET, FILM COATED807

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-32869842-328-02, 69842-328-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM25MG;220MGTABLET / ORAL2020-09-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-2484e616aacf4f…
2026-08-18 06:07:402026-07A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-244b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213663-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2020-09-24a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen Sodium Diphenhydramine HClNAPROXEN SODIUM DIPHENHYDRAMINE HCLCVS PHARMACY, INCbdac694e-ab2a-376d-e053-2a95a90a94672025-12-19WarningsExact identifier
ndc (package): 69842-328-02
ndc (package): 69842-328-08
ndc (product): 69842-328
ndc11 (package): 69842032808
ndc11 (package): 69842032802
spl id: 46540a23-aad6-6637-e063-6394a90a569e
spl set id: bdac694e-ab2a-376d-e053-2a95a90a9467

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.