All Day

Product NDC
49781-101
11-digit product format
497810101
Labeler code
49781
Product ID
49781-101_4c952477-9cdb-4aa5-9547-7a3e99b9c15c
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health (Leader) 49781
Application
ANDA091353
Marketing category
ANDA
Marketing start
2014-07-31
Marketing end
2020-07-31
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49781-101DDiscontinued by firm2026-07-31
excluded packagepackage49781-10149781-101-50DDiscontinued by firm2026-07-31
excluded packagepackage49781-10149781-101-51DDiscontinued by firm2026-07-31
excluded packagepackage49781-10149781-101-56DDiscontinued 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
A091353-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2011-09-20

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 22:54:322026-06A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20a50c72e98297…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rapidol NaproxenNAPROXEN SODIUMPharmadel LLCc94c4b6e-a48b-cee5-e053-2995a90a49ac2026-03-20WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Naproxen SodiumNAPROXEN SODIUMGranules USA, Inc.8cb8030c-b281-315c-e053-2a95a90a36f02025-12-22WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
NaproxenNAPROXENSafeway, Incf2a273f8-d623-dc2f-e053-2995a90a0c022025-12-19WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Naproxen SodiumNAPROXEN SODIUMSafeway, Incf2a297c2-3898-5e47-e053-2995a90ab3cc2025-12-19WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Naproxen SodiumNAPROXEN SODIUMTARGET CORPORATIONfdb87abd-3176-dd62-e053-6394a90a6fcc2025-12-19WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Naproxen SodiumNAPROXEN SODIUMCVS1042b202-e8ee-1839-e063-6294a90ac90b2025-12-19WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Naproxen SodiumNAPROXEN SODIUMCVS10429d07-de96-5542-e063-6294a90a73712025-12-19WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Dr Simi All Day Pain ReliefNAPROXEN SODIUMFarmacias De Similares TX LLC3c6d4bb5-eb6f-944b-e063-6294a90ae8de2025-08-15WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Naproxen SodiumNAPROXEN SODIUMBi-Mart6d5cecc9-5095-477b-bfc7-45b6e7e689f02025-03-01WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
NAPROXEN SODIUMNAPROXEN SODIUMSPIRIT PHARMACEUTICALS,LLCa690dc39-95f2-4853-a291-05d7dc9a15512024-12-30WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Pain ReliefNAPROXEN SODIUMGobrands, Incae4bfa8c-ae41-4fcd-b584-872cc4d376832024-12-20WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
PROXEN NP 660NAPROXEN SODIUMOPMX LLC09990b2f-202e-b4df-e063-6394a90a055b2023-12-27WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Naproxen SodiumNAPROXEN SODIUMGranules India Ltd95ba1722-60ed-4a83-9f26-50c4de8cf1802023-02-06WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
All Day Pain ReliefNAPROXEN SODIUM TABLETS, 220 MGHealthLife of USA LLC7b0cb91e-5465-40ef-9f82-919f7d984f172017-06-01WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [CARDINAL HEALTH (LEADER) 49781]2
NAPROXENACTIVE MOIETY57Y76R9ATQALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [CARDINAL HEALTH (LEADER) 49781]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [CARDINAL HEALTH (LEADER) 49781]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [CARDINAL HEALTH (LEADER) 49781]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [CARDINAL HEALTH (LEADER) 49781]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [CARDINAL HEALTH (LEADER) 49781]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [CARDINAL HEALTH (LEADER) 49781]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [CARDINAL HEALTH (LEADER) 49781]2
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [CARDINAL HEALTH (LEADER) 49781]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [CARDINAL HEALTH (LEADER) 49781]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [CARDINAL HEALTH (LEADER) 49781]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [CARDINAL HEALTH (LEADER) 49781]2