Naproxen Sodium and Diphenhydramine HCl

Product NDC
69238-1422
11-digit product format
692381422
Labeler code
69238
Product ID
69238-1422_b9db3e35-7654-4bf3-8536-38f56b8780c7
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium and Diphenhydramine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA209726
Marketing category
ANDA
Marketing start
2018-10-23
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Active strength
25; 220 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM25MG;220MGTABLET / ORAL2018-10-23

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen Sodium and Diphenhydramine HClNAPROXEN SODIUM AND DIPHENHYDRAMINEAmneal Pharmaceuticals NY LLCcaca14cf-95f2-4c60-8bba-2154b8f353a32023-12-30WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

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 non-prescription 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 s...

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium and Diphenhydramine HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM25 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C, TC2D6JAD40
Rxcui1550957

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1422-2Naproxen Sodium and Diphenhydramine HCl1 in 1 CARTONTABLET, FILM COATED16
69238-1422-2Naproxen Sodium and Diphenhydramine HCl20 in 1 BOTTLETABLET, FILM COATED206
69238-1422-4Naproxen Sodium and Diphenhydramine HCl1 in 1 CARTONTABLET, FILM COATED16
69238-1422-4Naproxen Sodium and Diphenhydramine HCl40 in 1 BOTTLETABLET, FILM COATED406
69238-1422-6Naproxen Sodium and Diphenhydramine HCl160 in 1 BOTTLETABLET, FILM COATED1606
69238-1422-6Naproxen Sodium and Diphenhydramine HCl1 in 1 CARTONTABLET, FILM COATED16
69238-1422-8Naproxen Sodium and Diphenhydramine HCl1 in 1 CARTONTABLET, FILM COATED16
69238-1422-8Naproxen Sodium and Diphenhydramine HCl80 in 1 BOTTLETABLET, FILM COATED806

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1422-6EA - Each69238-14225da03a6e-0694-4ab3-8d56-5b0d50e9ed2e12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1422NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL (NAPROXEN SODIUM AND DIPHENHYDRAMINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]6Current NDC, Legacy NDC, 8 package rows20231231_caca14cf-95f2-4c60-8bba-2154b8f353a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550957diphenhydrAMINE HCl 25 MG / naproxen sodium 220 MG Oral TabletPSNcaca14cf-95f2-4c60-8bba-2154b8f353a36
1550957diphenhydramine hydrochloride 25 MG / naproxen sodium 220 MG Oral TabletSCDcaca14cf-95f2-4c60-8bba-2154b8f353a36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1422-2692381422021 BOTTLE in 1 CARTON (69238-1422-2) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-10-230000-00-00NoNoCurrent
69238-1422-4692381422041 BOTTLE in 1 CARTON (69238-1422-4) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-10-230000-00-00NoNoCurrent
69238-1422-6692381422061 BOTTLE in 1 CARTON (69238-1422-6) / 160 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-10-230000-00-00NoNoCurrent
69238-1422-8692381422081 BOTTLE in 1 CARTON (69238-1422-8) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-10-230000-00-00NoNoCurrent