Belmora Flanax

Product NDC
47682-037
11-digit product format
476820037
Labeler code
47682
Product ID
47682-037_ebf3deb7-0831-d81b-e053-2a95a90ae3be
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
ANDA079096
Marketing category
ANDA
Marketing start
2008-12-30
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
2026-12-31
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
A079096-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2008-12-16

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09A079096-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2008-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A079096-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2008-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Belmora Flanax
Listing expiration
2026-12-31

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
8591ca57-04ee-5053-e053-2991aa0aa4ddAvailable 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
47682-037-50Belmora Flanax1 in 1 PACKETTABLET, FILM COATED14
47682-037-50Belmora Flanax50 in 1 BOXTABLET, FILM COATED504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-037BELMORA FLANAX (NAPROXEN SODIUM) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]4Current NDC, Legacy NDC, 2 package rows20230111_8591ca57-04ee-5053-e053-2991aa0aa4dd.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique MediproxenNAPROXEN SODIUMSportpharm LLCf01adfcc-b32a-4a98-a4e7-2ce87b824b5a2026-04-24WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMHYVEE INC45a0c910-7dd7-6a42-e063-6394a90a491c2026-01-13WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMHYVEE INC45a00020-173b-a4a1-e063-6294a90ae3992026-01-13WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMVALU MERCHANDISERS COMPANY12748345-0d79-d6f8-e063-6394a90ab6c62025-12-11WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMVALU MERCHANDISERS COMPANY1274889d-803c-d7fd-e063-6394a90ab9a82025-12-11WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMChain Drug Marketing Associationd9e72c3f-addc-4391-a7a4-2680a3e7f5c42025-12-10WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMChain Drug Marketing Association2ee83008-c012-48d6-9479-65e7d6f50f4c2025-12-10WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMHarris Teeter27938b08-ff37-4587-aa81-5ec3ef21a28a2025-12-09WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
CAREALL NaproxenNAPROXEN SODIUMNew World Imports, Inc.d9a0c6e7-a70e-479a-9737-e81a2887c7782025-12-01WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
CAREALL Naproxen SodiumNAPROXEN SODIUMNew World Imports, Inc.3952324e-77f4-4117-a97a-ab56511300582025-12-01WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Medique at Home MediproxenNAPROXEN SODIUMUnifirst First Aid Corporationb591ba4f-d7d3-4c81-e053-2995a90a7c6e2025-09-09WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Medique MediproxenNAPROXEN SODIUMUnifirst First Aid Corporationf6261d45-df1f-483b-b013-3cd6f78d9d432025-09-08WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMAMERIFOODS TRADING COMPANYf6dd2150-1643-18ff-e053-6294a90a422b2025-07-15WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMMarc Glassman, Inc.684e03b6-74eb-4374-a512-1c01ea216b512025-07-15WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMMarc Glassman, Inc.eeda0edf-7054-42aa-af8e-4df38b918f812025-07-15WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMCHAIN DRUG MARKETING ASSOCIATION, INC.84b9e9a4-b805-420e-83be-ebe98776d1ee2025-06-20WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
NAPROXEN SODIUMNAPROXEN SODIUMAAA Pharmaceutical, Inc.5ea3217d-845d-4781-b849-6b00babdc2142025-06-17WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMFSA STORE INC.f4326f99-142b-0b70-e053-2995a90ac9512025-06-17WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMHarris Teeter38543976-ccbe-4af9-b01d-ae102452d4182025-05-21WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096
Naproxen SodiumNAPROXEN SODIUMCHAIN DRUG MARKETING ASSOCIATION, INC.04245a78-228e-439f-8ffb-9d9bc56c7bb72025-05-20WarningsExact identifier
application applno (ANDA): 079096
application number: ANDA079096

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN8591ca57-04ee-5053-e053-2991aa0aa4dd4
849574naproxen sodium 220 MG Oral TabletSCD8591ca57-04ee-5053-e053-2991aa0aa4dd4
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY8591ca57-04ee-5053-e053-2991aa0aa4dd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-037-504768200375050 PACKET in 1 BOX (47682-037-50) / 1 TABLET, FILM COATED in 1 PACKET50 packet2008-12-300000-00-00NoNoCurrent