Naproxen Sodium
- Manufacturer
- Direct_Rx
- Effective date
- 2021-06-09
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:38:36
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
WARNINGS SECTION
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
•
hives
•
facial swelling
•
asthma (wheezing)
•
shock
•
skin reddening
•
rash
•
blisters
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
•
are age 60 or older
•
have had stomach ulcers or bleeding problems
•
take a blood thinning (anticoagulant) or steroid drug
•
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
•
have 3 or more alcoholic drinks every day while using this product
•
take more or for a longer time than directed
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
•
if you have ever had an allergic reaction to any other pain reliever/fever reducer
•
right before or after heart surgery
Ask a doctor before use if
•
the stomach bleeding warning applies to you
•
you have a history of stomach problems, such as heartburn
•
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
•
you are taking a diuretic
•
you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
•
under a doctor’s care for any serious condition
•
taking any other drug
When using this product
•
take with food or milk if stomach upset occurs
Stop use and ask a doctor if
•
you experience any of the following signs of stomach bleeding:
•
feel faint
•
vomit blood
•
have bloody or black stools
•
have stomach pain that does not get better
•
you have symptoms of heart problems or stroke:
•
chest pain
•
trouble breathing
•
weakness in one part or side of body
•
slurred speech
•
leg swelling
•
pain gets worse or lasts more than 10 days
•
fever gets worse or lasts more than 3 days
•
you have difficulty swallowing
•
it feels like the pill is stuck in your throat
•
redness or swelling is present in the painful area
•
any new symptoms appear
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
CLOSE
INACTIVE INGREDIENT SECTION
FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72189-003-14 | EA - Each | 72189-003 | ce2349ab-a942-4b20-a6e9-77a8dfdcfbb7 | 1 | 2021-06-02 |
| 72189-003-30 | EA - Each | 72189-003 | bfdf9e33-28f9-48d4-839d-b3761c7c330b | 1 | 2021-09-07 |
| 72189-003-40 | EA - Each | 72189-003 | 00a22f5a-c817-40b5-871c-e88f8c8204fc | 1 | 2019-08-06 |
| 0113-4368-62 | EA - Each | 0113-4368 | bc67d066-2a1e-4806-a7c1-e232b732e93b | 1 | 2018-02-20 |
| 0113-4368-71 | EA - Each | 0113-4368 | 993338e5-109e-4ef6-9be0-b5f443412b57 | 1 | 2018-02-20 |
| 0113-4368-76 | EA - Each | 0113-4368 | 44440010-53b4-4de7-9f66-fda678f65a35 | 1 | 2024-02-14 |
| 0113-4368-78 | EA - Each | 0113-4368 | e8dafb0f-462d-4fc5-bfb9-c6567df41bbd | 1 | 2017-03-06 |
| 0113-4368-79 | EA - Each | 0113-4368 | 4abd9a15-8206-4d60-bf29-504433dc3b29 | 1 | 2023-03-13 |
Products#
Every source-derived product name is available through these pages.
- Naproxen Sodium
- TALC
- HYPROMELLOSES
- POVIDONE
- FD&C BLUE NO. 2
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- TITANIUM DIOXIDE
- NAPROXEN
- POLYETHYLENE GLYCOL, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72189-003 | 72189-003-40, 72189-003-14, 72189-003-30 |
| 0113-4368 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TALC | 7SEV7J4R1U | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POVIDONE | FZ989GH94E | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074661-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074661-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 1997-01-13 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074661-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 1997-01-13 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Good Sense Naproxen Sodium | NAPROXEN SODIUM | L. Perrigo Company | 8e150c00-8e5b-40b4-a964-cb70442c2752 | 2026-05-11 | Warnings | 0113-4368 |
| cb1938e7-07a5-3807-e053-2995a90aa45a | 8bae24c6-72eb-c94e-e053-2a95a90a0bb0 | 2021-09-03 | Warnings | 8bae24c6-72eb-c94e-e053-2a95a90a0bb0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
