FDA.reportPublic FDA data

Naproxen Sodium PM

Product NDC
55910-854
Requested package NDC
55910-854-20
11-digit product format
559100854
Labeler code
55910
Product ID
55910-854_a662cc95-9cef-4ee0-a4bd-c75b20392d78
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Application
ANDA209726
Marketing category
ANDA
Marketing start
2018-12-31
Marketing end
2025-09-30
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Active strength
25 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
0000-00-00
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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55910-85455910-854-20DDiscontinued by firm2026-07-31

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
A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM25MG;220MGTABLET / ORAL2018-10-23

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 22:54:322026-06A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23a50c72e98297…

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen Sodium PMNAPROXEN SODIUMStrategic Sourcing Services LLC7aadfdd4-f8f5-4b7a-a388-1889c3d7d8ba2025-08-20WarningsExact identifier
application applno (ANDA): 209726
application number: ANDA209726
Naproxen Sodium PMNAPROXEN SODIUMStrategic Sourcing Services LLC03a331d8-c957-4949-894f-51d9bd15e0d02025-08-20WarningsExact identifier
application applno (ANDA): 209726
application number: ANDA209726
Naproxen Sodium and Diphenhydramine HClNAPROXEN SODIUM AND DIPHENHYDRAMINEAmneal Pharmaceuticals NY LLCcaca14cf-95f2-4c60-8bba-2154b8f353a32023-12-30WarningsExact identifier
application applno (ANDA): 209726
application number: ANDA209726

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-854-202020-12-04C16284748780-1ab0e2407-2672-f274-e053-dbdaa90a6471Drug Facts
55910-854-402020-12-04C16284748780-1ab0e2407-2672-f274-e053-dbdaa90a6471Drug Facts
55910-854-202020-09-27C16284748780-1ab0e2407-2672-f274-e053-dbdaa90a6471Drug Facts
55910-854-402020-09-27C16284748780-1ab0e2407-2672-f274-e053-dbdaa90a6471Drug Facts
55910-854-202020-09-25C16284748780-1ab0e2407-2672-f274-e053-dbdaa90a6471Drug Facts
55910-854-402020-09-25C16284748780-1ab0e2407-2672-f274-e053-dbdaa90a6471Drug Facts
55910-854-202020-07-22C16284748780-1ab0e2407-2672-f274-e053-dbdaa90a6471Drug Facts
55910-854-402020-07-22C16284748780-1ab0e2407-2672-f274-e053-dbdaa90a6471Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-854NAPROXEN SODIUM PM (NAPROXEN SODIUM) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3Legacy NDC20221203_a16d1925-c01e-4a00-ba01-e9d699b65e7d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-854-20559100854201 BOTTLE, PLASTIC in 1 BOX (55910-854-20) > 20 TABLET in 1 BOTTLE, PLASTIC2018-12-312025-09-30NoNoCurrent