Naproxen

Product NDC
61010-4410
11-digit product format
610104410
Labeler code
61010
Product ID
61010-4410_f8ad2d5e-1cc7-46b3-8579-21bedd2c5d6e
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Safetec of America, Inc.
Application
ANDA091353
Marketing category
ANDA
Marketing start
2020-01-20
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61010-4410IInactivated by FDA2026-07-31
excluded packagepackage61010-441061010-4410-0IInactivated by FDA2026-07-31
excluded packagepackage61010-441061010-4410-1IInactivated by FDA2026-07-31
excluded packagepackage61010-441061010-4410-2IInactivated by FDA2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091353-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2011-09-20

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
Rapidol NaproxenNAPROXEN SODIUMPharmadel LLCc94c4b6e-a48b-cee5-e053-2995a90a49ac2026-03-20WarningsExact identifier
Naproxen SodiumNAPROXEN SODIUMGranules USA, Inc.8cb8030c-b281-315c-e053-2a95a90a36f02025-12-22WarningsExact identifier
NaproxenNAPROXENSafeway, Incf2a273f8-d623-dc2f-e053-2995a90a0c022025-12-19WarningsExact identifier
Naproxen SodiumNAPROXEN SODIUMSafeway, Incf2a297c2-3898-5e47-e053-2995a90ab3cc2025-12-19WarningsExact identifier
Naproxen SodiumNAPROXEN SODIUMTARGET CORPORATIONfdb87abd-3176-dd62-e053-6394a90a6fcc2025-12-19WarningsExact identifier
Naproxen SodiumNAPROXEN SODIUMCVS1042b202-e8ee-1839-e063-6294a90ac90b2025-12-19WarningsExact identifier
Naproxen SodiumNAPROXEN SODIUMCVS10429d07-de96-5542-e063-6294a90a73712025-12-19WarningsExact identifier
Dr Simi All Day Pain ReliefNAPROXEN SODIUMFarmacias De Similares TX LLC3c6d4bb5-eb6f-944b-e063-6294a90ae8de2025-08-15WarningsExact identifier
Naproxen SodiumNAPROXEN SODIUMBi-Mart6d5cecc9-5095-477b-bfc7-45b6e7e689f02025-03-01WarningsExact identifier
NAPROXEN SODIUMNAPROXEN SODIUMSPIRIT PHARMACEUTICALS,LLCa690dc39-95f2-4853-a291-05d7dc9a15512024-12-30WarningsExact identifier
Pain ReliefNAPROXEN SODIUMGobrands, Incae4bfa8c-ae41-4fcd-b584-872cc4d376832024-12-20WarningsExact identifier
PROXEN NP 660NAPROXEN SODIUMOPMX LLC09990b2f-202e-b4df-e063-6394a90a055b2023-12-27WarningsExact identifier
Naproxen SodiumNAPROXEN SODIUMGranules India Ltd95ba1722-60ed-4a83-9f26-50c4de8cf1802023-02-06WarningsExact identifier
All Day Pain ReliefNAPROXEN SODIUM TABLETS, 220 MGHealthLife of USA LLC7b0cb91e-5465-40ef-9f82-919f7d984f172017-06-01WarningsExact identifier

Warnings cross-check#

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

warnings

Warnings Allergy a lert: Naproxen sodium may cause severe skin reactions. 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 right before or after heart surgery Ask a doctor before use if the stomach bleeding warning applies to you 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 problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are 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 drugs When using this product 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 slurred speech leg swelling weakness in one part or side of body pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing it feels like the pill is stuck in your throat redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or...

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-4410-0Naproxen1 in 1 POUCHTABLET12
61010-4410-1Naproxen50 in 1 CARTONTABLET502
61010-4410-2Naproxen100 in 1 CARTONTABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-4410NAPROXEN (NAPROXEN SODIUM) TABLET [SAFETEC OF AMERICA, INC.]2Legacy NDC, 3 package rows20200125_287a381a-df7e-4e93-b097-1efde8a5f120.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN287a381a-df7e-4e93-b097-1efde8a5f1202
849574naproxen sodium 220 MG Oral TabletSCD287a381a-df7e-4e93-b097-1efde8a5f1202
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY287a381a-df7e-4e93-b097-1efde8a5f1202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-4410-0610104410001 TABLET in 1 POUCH (61010-4410-0) 1 tablet2020-01-200000-00-00NoNoCurrent
61010-4410-16101044100150 POUCH in 1 CARTON (61010-4410-1) > 1 TABLET in 1 POUCH (61010-4410-0) 50 pouch2020-01-200000-00-00NoNoCurrent
61010-4410-261010441002100 POUCH in 1 CARTON (61010-4410-2) > 1 TABLET in 1 POUCH (61010-4410-0) 100 pouch2020-01-200000-00-00NoNoCurrent