Indications and uses
temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever
temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever
do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose adults and children 12 years and older: take 1 caplet every 8 to 12 hours while symptoms last for the first dose you may take 2 caplets within the first hour do not exceed 2 caplets in any 8- to 12-hour period do not exceed 3 caplets in a 24-hour period children under 12 years: ask a doctor
each caplet contains: sodium 20 mg store at 20º to 25ºC (68º to 77ºF). Avoid high humidity and excessive heat above 40ºC (104ºF). read all warnings and directions before use. Keep carton.
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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:
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
FD&C blue #2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide
Call toll free 1-888-423-0139
NON-PRESCRIPTION STRENGTH
All Day Pain Relief
NAPROXEN SODIUM TABLETS/ 220 mg EACH
Caplets
COMPARE TO ALEVE® active ingredient†
†This product is not manufactured or distributed by Bayer Healthcare, LLC., owner of the registered trademark Aleve®.
DO NOT USE IF INNER SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY TOPCO ASSOCIATED LLC
ELK GROVE VILLAGE, IL 60007
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A CORN | INACTIVE INGREDIENT | AG9B65PV6B | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 36800-055 | 36800-055-24, 36800-055-50, 36800-055-01, 36800-055-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| ALUMINUM OXIDE | LMI26O6933 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SOLUTION / ORAL | 300 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SOLUTION/ DROPS / OPHTHALMIC | 4 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | TABLET / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | FILM / SUBLINGUAL | 7 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, COATED / ORAL | 24.12 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 221 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / SUBLINGUAL | 30 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | POWDER, FOR SUSPENSION / ORAL | 257 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, DELAYED RELEASE / ORAL | 105 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, FILM COATED / ORAL | 2 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, DELAYED RELEASE / ORAL | 516 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYSTEM / TOPICAL | 54 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED PELLETS / ORAL | 3.32 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE / ORAL | 540 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / ORAL | 2828 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091353-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A091353-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2011-09-20 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A091353-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2011-09-20 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| b88549e9-aaa3-4e77-acc6-51336444e3bb | ff5c3525-6389-4bfa-8092-d8d91a54ab50 | 2019-10-15 | Warnings | b88549e9-aaa3-4e77-acc6-51336444e3bb ff5c3525-6389-4bfa-8092-d8d91a54ab50 |
Adverse event summaries are temporarily unavailable. Other product information remains available.