signature care naproxen sodium

Product NDC
21130-180
Requested package NDC
21130-180-62
11-digit product format
211300180
Labeler code
21130
Product ID
21130-180_347809fc-ce5e-49ff-b4e5-a36aa9eb6a72
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Safeway
Application
ANDA074661
Marketing category
ANDA
Marketing start
2018-04-03
Marketing end
2027-02-28
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
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage21130-18021130-180-62DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

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
A074661-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL1997-01-13

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 UTC2026-02A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133f01610625f2…
2019-09-15 20:21 UTC2019-09A074661-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL1997-01-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A074661-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL1997-01-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074661-001NAPROXEN SODIUM220MGTABLET / ORAL1997-01-13cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
signature care naproxen sodium

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
85f78e63-98aa-4cf3-887d-0ac535184f97Available 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
21130-180-62signature care naproxen sodium1 in 1 CARTONTABLET, FILM COATED16
21130-180-62signature care naproxen sodium24 in 1 BOTTLETABLET, FILM COATED246
21130-180-71signature care naproxen sodium1 in 1 CARTONTABLET, FILM COATED16
21130-180-71signature care naproxen sodium50 in 1 BOTTLETABLET, FILM COATED506
21130-180-75signature care naproxen sodium90 in 1 BOTTLETABLET, FILM COATED906
21130-180-75signature care naproxen sodium1 in 1 CARTONTABLET, FILM COATED16
21130-180-78signature care naproxen sodium100 in 1 BOTTLETABLET, FILM COATED1006
21130-180-78signature care naproxen sodium1 in 1 CARTONTABLET, FILM COATED16
21130-180-79signature care naproxen sodium400 in 1 BOTTLETABLET, FILM COATED4006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-180SIGNATURE CARE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [SAFEWAY]5Current NDC, Legacy NDC, 9 package rows20250308_85f78e63-98aa-4cf3-887d-0ac535184f97.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 3 · 56 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Naproxen SodiumNAPROXEN SODIUMPreferred Pharmaceuticals Inc.2183df53-ac90-4d43-8a5d-8421036bc4cb2026-07-28WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Naproxen SodiumNAPROXEN SODIUMPD-Rx Pharmaceuticals, Inc.d2b1eedb-2be0-42af-ba0b-9da98560c91e2026-07-24WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
naproxen sodiumNAPROXEN SODIUMH E Bb5dcf3df-2628-49c7-9d96-64886bebe6312026-07-13WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Naproxen SodiumNAPROXEN SODIUMPD-Rx Pharmaceuticals, Inc.c5146d73-2f34-4dfe-ac29-97071279dc4d2026-05-26WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Berkley and Jensen Naproxen SodiumNAPROXEN SODIUMBJWC9530b649-3e01-452c-99a6-cff47fa4085b2026-05-21WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Good Sense Naproxen SodiumNAPROXEN SODIUML. Perrigo Company8e150c00-8e5b-40b4-a964-cb70442c27522026-05-11WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
equaline naproxen sodiumNAPROXEN SODIUMUnited Natural Foods, Inc. dba UNFI89c02e55-fa08-4001-96fc-8a01e7e74d5a2026-05-06WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
all day reliefNAPROXEN SODIUMPublix Super Markets Inc0f8843be-50a3-442c-9016-d9da3b444f602026-05-06WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
rugby all day reliefNAPROXEN SODIUMRugby Laboratoriesf587a428-291c-4c54-80fe-244a961b05212026-05-06WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Naproxen SodiumNAPROXEN SODIUMCVS Pharmacyefe4352f-856b-4ada-8bd4-0a78423447dc2026-02-27WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Topcare All Day Pain ReliefNAPROXEN SODIUMTopco Associates LLC7f1cda40-9a67-4de1-af56-ab881c6354c42026-02-11WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
naproxen sodiumNAPROXEN SODIUMH E B2f9439bb-e808-4c54-ba61-f75f117c8b372026-02-11WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Naproxen SodiumNAPROXEN SODIUMPadagis Israel Pharmaceuticals Ltdcdb60f74-ce23-4015-90eb-b23a2275f6cb2026-02-11WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
topcare back and muscle painNAPROXEN SODIUMTopco Associates LLCde587e8f-38f2-4e7a-8e6a-64e48f280c4f2026-02-07WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Naproxen SodiumNAPROXEN SODIUMMeijer Distribution Incdb87d1da-8507-4bbf-aefc-3dbd48cde26b2026-02-05WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Rugby All Day ReliefNAPROXEN SODIUMBryant Ranch Prepack3238dfdc-82d1-4afb-b27c-0ba0a5d247442026-02-04WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Good Sense Naproxen SodiumNAPROXEN SODIUML. Perrigo Company6bc74cda-458c-480e-a33c-d2ba68d5e6bd2026-01-29WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Care One Naproxen SodiumNAPROXEN SODIUMAmerican Sales Companybc5ddcf2-640c-4683-a60f-ca1c8b4188732026-01-29WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
Leader All Day Pain ReliefNAPROXEN SODIUMCardinal Health 110, LLC. dba Leaderdbf007f5-c792-43a7-8cc1-bfa617f3a7fa2026-01-26WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661
naproxen sodiumNAPROXEN SODIUMMeijer Distribution Incf4e57560-ae89-4fc3-a66b-ebf3dc3f24482026-01-22WarningsExact identifier
application applno (ANDA): 074661
application number: ANDA074661

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN85f78e63-98aa-4cf3-887d-0ac535184f976
849574naproxen sodium 220 MG Oral TabletSCD85f78e63-98aa-4cf3-887d-0ac535184f976
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY85f78e63-98aa-4cf3-887d-0ac535184f976

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-180-62211300180621 BOTTLE in 1 CARTON (21130-180-62) > 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-04-030000-00-00NoNoCurrent