FDA.reportPublic FDA data

Lil Drug Store Pain Relief

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-03-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:10:30

Label at a glance#

ProductLil Drug Store Pain Relief All Day
Active ingredientNAPROXEN SODIUM
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache 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 and children 12 years and over 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 over age 65 do not take more than 1 tablet ever...

Storage and handling

read all warnings and directions before use. Keep vial. each tablet contains: sodium 20 mg store at room temperature 20-25°C (68-77°F). avoid high humidity and excessive heat above 40°C (104°F). do not use if vial is open or damaged or safety seal has been removed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) 1

1 nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

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, or kidney disease
  • you are taking a diuretic.
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma

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 any other drug

When using this product

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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.
  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 and children 12 years and over
  • 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
over age 65
  • do not take more than 1 tablet every 12 hours unless directed by a doctor
children under 12 years
  • ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • read all warnings and directions before use. Keep vial.
  • each tablet contains: sodium 20 mg
  • store at room temperature 20-25°C (68-77°F).
  • avoid high humidity and excessive heat above 40°C (104°F).
  • do not use if vial is open or damaged or safety seal has been removed

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-877-507-6516 (M-F 8 AM-4:30PM CST)

PRINCIPAL DISPLAY PANEL - 220 mg Tablet Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

★ QUALITY GUARANTEED ★

Compare to the Active
Ingredient in Aleve®**

All Day
Pain Relief
Naproxen Sodium (NSAID)
Pain Reliever/Fever Reducer, 220 mg

12
Tablets

Lil'
Drug Store ®

OPEN HERE FOR DRUG FACTS INFORMATION

PRINCIPAL DISPLAY PANEL - 220 mg Tablet Vial Label
PRINCIPAL DISPLAY PANEL - 220 mg Tablet Vial Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
849574naproxen sodium 220 MG Oral TabletPSN6
849574naproxen sodium 220 MG Oral TabletSCD6
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY6

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
66715-9740-4Lil Drug Store Pain ReliefAll Day12 in 1 VIALTABLET126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9740LIL DRUG STORE PAIN RELIEF ALL DAY (NAPROXEN SODIUM) TABLET [LIL' DRUG STORE PRODUCTS, INC.]6Current NDC, Legacy NDC, 1 package rows20240402_41d2d995-47ef-419d-8e57-ea3f9f8a9f68.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Naproxen SodiumACTIVE INGREDIENT9TN87S3A3C1
NaproxenACTIVE MOIETY57Y76R9ATQ1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH481
FD&C blue NO. 2INACTIVE INGREDIENTL06K8R7DQK1
Magnesium StearateINACTIVE INGREDIENT70097M6I301
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1A1
Polyvinyl AlcoholINACTIVE INGREDIENT532B59J9901
PovidonesINACTIVE INGREDIENTFZ989GH94E1
Starch, CornINACTIVE INGREDIENTO8232NY3SJ1
TalcINACTIVE INGREDIENT7SEV7J4R1U1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-974066715-9740-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C BLUE NO. 2L06K8R7DQKIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
NAPROXEN SODIUM9TN87S3A3CACTIB

Source Document#

Source XML

Inactive ingredient matches#

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.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Polyvinyl AlcoholPOLYVINYL ALCOHOL532B59J990TABLET / ORAL165 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Croscarmellose SodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PovidonesPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Polyvinyl AlcoholPOLYVINYL ALCOHOL532B59J990TABLET / ORAL165 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C blue NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET / ORAL25 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C blue NO. 2FD&C BLUE NO. 2L06K8R7DQKTABLET / ORAL25 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PovidonesPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Croscarmellose SodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1684e616aacf4f…
2026-08-18 06:07:402026-07A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16caaa826d4ba7…
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…

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
Lil Drug Store Pain Relief All DayNAPROXEN SODIUMLil' Drug Store Products, Inc.41d2d995-47ef-419d-8e57-ea3f9f8a9f682024-03-29WarningsExact identifier
ndc (package): 66715-9740-4
ndc (product): 66715-9740
ndc11 (package): 66715974004
spl id: 14cdfee7-42be-4d04-e063-6394a90ac63a
spl set id: 41d2d995-47ef-419d-8e57-ea3f9f8a9f68

Reported adverse events (FAERS/openFDA)#

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