FDA.reportPublic FDA data

Rapidol Naproxen

Manufacturer
Pharmadel LLC
Effective date
2026-03-20
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:51:02

Label at a glance#

ProductRapidol Naproxen
Active ingredientNAPROXEN SODIUM
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to minor pain from arthritis menstrual cramps muscular aches headache backache toothache the common cold temporarily reduces fever

Dosage and administration

do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose adults & children 12 years of age and older take 1 tablet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8 to 12 hour period do not exceed 3 Tablets in a 24-hour period children under 12 years of age consult a do...

Storage and handling

each caplet contains: sodium 20 mg store between 68-77°F (20-25°C). Avoid high humidity and excessive heat above 104°F (40°C)

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient and Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each caplet) Purposes

Naproxen sodium 220mg

(naproxen 200mg) (NSAID*)

Pain reliver/ fever reducer
*nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to
  • minor pain from arthritis
  • menstrual cramps
  • muscular aches
  • headache
  • backache
  • toothache
  • the common cold
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Allergy alert: Naproxen sodium may cause severe skin reactions. 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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drugs

When using this product

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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
  • slurred speech
  • leg swelling
  • weakness in one part or side of body
  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: sodium 20 mg
  • store between 68-77°F (20-25°C). Avoid high humidity and excessive heat above 104°F (40°C)

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • the smallest effective dose should be used
  • drink a full glass of water with each dose

adults & children 12 years of age and older

  • take 1 tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within the first hour
  • do not exceed 2 tablets in any 8 to 12 hour period
  • do not exceed 3 Tablets in a 24-hour period
children under 12 years of age
  • consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone k30, sodium starch glycolate, stearic acid, titanium dioxide, water

Distributed by/ Distribuido por:

SPL UNCLASSIFIED SECTION

PHARMADEL LLC

New Castle, DE 19720

Questions? +1-866-359-3478

Made in India/ Hecho en India

†This product is not manufactured or distributed by Bayer Health Care LLC., distributor of Aleve® caplets. Aleve® is a registered mark of Bayer Health Care LLC.

Prrinicpal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP NAPROXENOPDP NAPROXENO

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
849574naproxen sodium 220 MG Oral TabletPSN11
849574naproxen sodium 220 MG Oral TabletSCD11
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NAPROXEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

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
55758-048-02Rapidol Naproxen2 in 1 PACKETTABLET, COATED211
55758-048-24Rapidol Naproxen1 in 1 CARTONTABLET, COATED111
55758-048-24Rapidol Naproxen24 in 1 BOTTLETABLET, COATED2411
55758-048-50Rapidol Naproxen25 in 1 CARTONTABLET, COATED2511

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-04855758-048-24, 55758-048-02, 55758-048-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
FD&C BLUE NO. 2--ALUMINUM LAKE4AQJ3LG584IACT
STARCH, CORNO8232NY3SJIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONE K30U725QWY32XIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
NAPROXEN SODIUM9TN87S3A3CACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2084e616aacf4f…
2026-08-18 06:07:402026-07A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-203f01610625f2…
2019-09-15 20:21 UTC2019-09A091353-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2011-09-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A091353-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2011-09-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20f41ea6bd6efb…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rapidol NaproxenNAPROXEN SODIUMPharmadel LLCc94c4b6e-a48b-cee5-e053-2995a90a49ac2026-03-20WarningsExact identifier
ndc (package): 55758-048-50
ndc (package): 55758-048-02
ndc (package): 55758-048-24
ndc (product): 55758-048
ndc11 (package): 55758004850
ndc11 (package): 55758004802
ndc11 (package): 55758004824
spl id: 4d7ad592-5b3b-e731-e063-6394a90a11e0
spl set id: c94c4b6e-a48b-cee5-e053-2995a90a49ac

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.