Naproxen Sodium PM

Product NDC
55315-844
11-digit product format
553150844
Labeler code
55315
Product ID
55315-844_69b15b18-59e8-4225-9dae-52b1bb11907d
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Freds Inc
Application
ANDA209726
Marketing category
ANDA
Marketing start
2019-02-28
Marketing end
0000-00-00
Substance
NAPROXEN SODIUM; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
220 mg/1; 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 productproduct55315-844DDiscontinued by firm2026-07-31
excluded packagepackage55315-84455315-844-20DDiscontinued by firm2026-07-31

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 PMNAPROXEN SODIUMStrategic Sourcing Services LLC7aadfdd4-f8f5-4b7a-a388-1889c3d7d8ba2025-08-20WarningsExact identifier
Naproxen Sodium PMNAPROXEN SODIUMStrategic Sourcing Services LLC03a331d8-c957-4949-894f-51d9bd15e0d02025-08-20WarningsExact identifier
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 have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55315-844-202020-10-27C16284748780-1ab0e2407-2a85-f274-e053-dbdaa90a6471Drug Facts
55315-844-202020-09-27C16284748780-1ab0e2407-2a85-f274-e053-dbdaa90a6471Drug Facts
55315-844-202020-09-25C16284748780-1ab0e2407-2a85-f274-e053-dbdaa90a6471Drug Facts
55315-844-202020-07-22C16284748780-1ab0e2407-2a85-f274-e053-dbdaa90a6471Drug Facts

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55315-844-20553150844201 BOTTLE, PLASTIC in 1 BOX (55315-844-20) > 20 TABLET in 1 BOTTLE, PLASTIC2019-02-280000-00-00NoNoCurrent