Naproxen Sodium

Manufacturer: Chain Drug Marketing Association
Effective date: 2025-12-10
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:21:34

Label at a glance#

ProductNaproxen Sodium

Active ingredientNAPROXEN SODIUM

Label structure9 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 do not take longer than 10 days, unless directed by a doctor (see Warnings ) 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 ...

Storage and handling

each caplet contains: sodium 20 mg store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F). retain carton for complete product information

Contacts and useful links#

PhoneFDA MedWatch1-800-FDA-1088

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

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

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 asthma
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 any other drug

When using this product

OTC - WHEN USING SECTION

take with food or milk if stomach upset occurs
long term continuous use may increase the risk of heart attack or stroke

Stop use and ask a doctor if

OTC - STOP USE SECTION

side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
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
you develop heartburn
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
do not take longer than 10 days, unless directed by a doctor (see Warnings)
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

Other information

STORAGE AND HANDLING SECTION

each caplet contains: sodium 20 mg
store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
retain carton for complete product information

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63868-466-50

QUALITY CHOICE

†Compare to the active ingredient in ALEVE®

Naproxen Sodium

Non-Prescription Strength

Naproxen Sodium Tablets, 220mg

Pain Reliever / Fever Reducer (NSAID)

50 Caplets** (**Capsule-Shaped Tablets)

50 count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
849574	naproxen sodium 220 MG Oral Tablet	PSN	4
849574	naproxen sodium 220 MG Oral Tablet	SCD	4
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
NAPROXEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0635515974562	GTIN-13: 0635515974562 EAN-13: 0635515974562 GTIN-12: 635515974562 UPC-A: 635515974562 GTIN storage (14 digits): 00635515974562	F114502QCH_R2_DF040710.jpg
Data code	Data Matrix	F114502QCH_R2		F114502QCH_R2_DF040710.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63868-466-01	Naproxen Sodium	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	4
63868-466-01	Naproxen Sodium	1 in 1 CARTON	TABLET, COATED	1	4
63868-466-25	Naproxen Sodium	1 in 1 CARTON	TABLET, COATED	1	4
63868-466-25	Naproxen Sodium	24 in 1 BOTTLE, PLASTIC	TABLET, COATED	24	4
63868-466-50	Naproxen Sodium	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	4
63868-466-50	Naproxen Sodium	1 in 1 CARTON	TABLET, COATED	1	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-466-01	EA - Each	63868-466	62fd4e1c-2b7f-4fbd-af11-c820026a9c2e	1	2022-09-12
63868-466-25	EA - Each	63868-466	545eca9a-239e-4d71-b91b-13fa9b403add	1	2022-10-06
63868-466-50	EA - Each	63868-466	69d60864-751e-4747-a908-26b9d1b95c4a	1	2022-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Naproxen Sodium
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL, UNSPECIFIED
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
STARCH, CORN
TALC
TITANIUM DIOXIDE
NAPROXEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63868-466	63868-466-25, 63868-466-50, 63868-466-01

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
Name	UNII	Kind
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
NAPROXEN SODIUM	9TN87S3A3C	ACTIB

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 · 32 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	TABLET, COATED / ORAL	0.7 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, COATED / ORAL	24.12 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, COATED / ORAL	24.12 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, COATED / ORAL	24.12 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	TABLET, COATED / ORAL	0.7 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, COATED / ORAL	24.12 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	TABLET, COATED / ORAL	0.7 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	TABLET, COATED / ORAL	0.7 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route+dosage form 4 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079096-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2008-12-16

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079096-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2008-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079096-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2008-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079096-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2008-12-16	`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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium	NAPROXEN SODIUM	Chain Drug Marketing Association	2ee83008-c012-48d6-9479-65e7d6f50f4c	2025-12-10	Warnings	Exact identifier ndc (package): 63868-466-25 ndc (package): 63868-466-50 ndc (package): 63868-466-01 ndc (product): 63868-466 ndc11 (package): 63868046601 ndc11 (package): 63868046650 ndc11 (package): 63868046625 spl id: 459b1f3a-7730-da84-e063-6294a90ad9c5 spl set id: 2ee83008-c012-48d6-9479-65e7d6f50f4c

Reported adverse events (FAERS/openFDA)#

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