FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
50844-604
Requested package NDC
50844-604-56
11-digit product format
508440604
Labeler code
50844
Product ID
50844-604_89d3ed35-e75c-41d8-aa99-57cc1fd866d2
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
ANDA204872
Marketing category
ANDA
Marketing start
2017-02-01
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A204872-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2017-01-23

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
2026-08-01 22:54:322026-06A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXEN SODIUMPreferred Pharmaceuticals, Inc.20eb9d9f-11df-464f-a1b0-949f8fda40422026-07-28WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Back and Muscle PainNAPROXEN SODIUMCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4039504c-e612-4503-854a-62ee067809562026-07-13WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Naproxen SodiumNAPROXEN SODIUMLidl US LLC3d01220c-c5ec-4604-8cef-9ecb807ccd532026-06-22WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Naproxen SodiumNAPROXEN SODIUMRite Aid Corporation134e5ec6-c42a-43b6-adf2-2d7546875ead2026-06-19WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Naproxen Headache PainNAPROXEN SODIUML.N.K. International, Inc.6161b881-f422-47ae-86ba-a28d669bce792026-06-18WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
NaproxenNAPROXEN SODIUMFamily Dollar Services Incd9c63e1f-c2ad-434b-8a21-7fff21b7477b2026-06-03WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Naproxen SodiumNAPROXEN SODIUMRite Aid Corporatione6277515-c606-4535-9c29-08cade045aee2026-05-14WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Naproxen Back and Muscle PainNAPROXEN SODIUML.N.K. International, Inc.68944663-0dc0-4d3a-a36b-019061bdbfa02026-03-09WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
AnaDentNAPROXEN SODIUMBelmora LLC236674db-da4d-415c-a160-7086eaf5bff52026-03-03WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Naproxen SodiumNAPROXEN SODIUML.N.K. International, Inc.717518e4-2537-4229-b765-c6acfe963d4b2026-02-25WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
ndc (package): 50844-604-56
ndc (product): 50844-604
ndc11 (package): 50844060456
Naproxen SodiumNAPROXEN SODIUMBetter Living Brands, LLC3eeb07fe-fcf1-4ea7-b0c2-9cb04f88c0412026-02-13WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Back and Muscle PainNAPROXEN SODIUMRite Aid Corporatione162bd50-f94a-4c76-8f1b-62114f2838092026-02-11WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Flanax Menstrual Pain RelieverNAPROXEN SODIUMBelmora LLC2b4135b3-389c-46e2-ae86-7674c2ab9a322026-01-27WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
FlanaxNAPROXEN SODIUMBelmora LLC2c099d45-f03a-4161-a6af-8fe5965f27482026-01-06WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
All Day Pain ReliefNAPROXEN SODIUMWALMART INC.c4909e43-57ba-44bc-a234-a02cc884891c2025-12-11WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
24/7 Life by 7-Eleven Naproxen SodiumNAPROXEN SODIUM TABLET, FILM COATEDLil' Drug Store Products, Inc.44716954-006a-4c56-e063-6294a90a0f142025-11-25WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
Naproxen SodiumNAPROXEN SODIUMAthlete's Needs Incd5984c9d-3941-45d6-8392-87564b2faae02025-11-15WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
NaproxenNAPROXEN SODIUMBetter Living Brands, LLC43745d42-f859-4168-a2dd-2c8ae47ae5902025-10-28WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
NaproxenNAPROXEN SODIUMFamily Dollar Services Incb6205032-f5c6-494a-8b87-adbbbc3982e72025-10-27WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872
NaproxenNAPROXEN SODIUMAmerisource Bergen1e2e6e3a-b095-4d5b-86fe-61eb44a87cf02025-10-20WarningsExact identifier
application applno (ANDA): 204872
application number: ANDA204872

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9TN87S3A3CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
849574Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
717518e4-2537-4229-b765-c6acfe963d4bAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50844-604-06Naproxen Sodium200 in 1 BOTTLE, PLASTICTABLET, FILM COATED20015
50844-604-09Naproxen Sodium4 in 1 CARTONTABLET, FILM COATED415
50844-604-09Naproxen Sodium5 in 1 BLISTER PACKTABLET, FILM COATED515
50844-604-14Naproxen Sodium500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50015
50844-604-15Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED115
50844-604-15Naproxen Sodium50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5015
50844-604-16Naproxen Sodium1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100015
50844-604-19Naproxen Sodium8 in 1 BOTTLE, PLASTICTABLET, FILM COATED815
50844-604-19Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED115
50844-604-56Naproxen Sodium25 in 1 BOTTLE, PLASTICTABLET, FILM COATED2515
50844-604-98Naproxen Sodium8 in 1 BOTTLE, PLASTICTABLET, FILM COATED815
50844-604-99Naproxen Sodium8 in 1 BOTTLE, PLASTICTABLET, FILM COATED815

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-604NAPROXEN SODIUM TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]13Current NDC, Legacy NDC, 12 package rows20250116_717518e4-2537-4229-b765-c6acfe963d4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN717518e4-2537-4229-b765-c6acfe963d4b15
849574naproxen sodium 220 MG Oral TabletSCD717518e4-2537-4229-b765-c6acfe963d4b15
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY717518e4-2537-4229-b765-c6acfe963d4b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50844-604-565084406045625 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-604-56) 2017-02-010000-00-00NoNoCurrent