dg health naproxen sodium

Manufacturer: Dolgencorp Inc
Effective date: 2025-01-22
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:53:54

Label at a glance#

Productdg health naproxen sodium

Active ingredientNAPROXEN SODIUM

Label structure8 sections

Indications and uses

• temporarily relieves minor aches and pains due to: • backache • muscular aches • minor pain of arthritis • 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 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: • ask a...

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

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

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 drug

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
- 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,

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 in 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).

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 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:

ask a doctor

Other information

OTHER SAFETY INFORMATION

each tablet contains: sodium 22 mg
store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive ingredients

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DG™ | health

Compare to the active ingredient of Aleve^®Back & Muscle Pain

Naproxen Sodium Tablets, 220 mg

Pain Reliever/Fever Reducer (NSAID)

STRENGTH TO LAST 12 HOURS

For temporary relief of minor back and muscle aches and pains

BACK & MUSCLE PAIN

50 Tablets

Actual Tablet Size

220 mg

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

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
55910-729-62	dg health naproxen sodium	24 in 1 BOTTLE	TABLET, FILM COATED	24	4
55910-729-62	dg health naproxen sodium	1 in 1 CARTON	TABLET, FILM COATED	1	4
55910-729-71	dg health naproxen sodium	1 in 1 CARTON	TABLET, FILM COATED	1	4
55910-729-71	dg health naproxen sodium	50 in 1 BOTTLE	TABLET, FILM COATED	50	4
55910-729-75	dg health naproxen sodium	1 in 1 CARTON	TABLET, FILM COATED	1	4
55910-729-75	dg health naproxen sodium	90 in 1 BOTTLE	TABLET, FILM COATED	90	4
55910-729-78	dg health naproxen sodium	100 in 1 BOTTLE	TABLET, FILM COATED	100	4
55910-729-78	dg health naproxen sodium	1 in 1 CARTON	TABLET, FILM COATED	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-729	DG HEALTH NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [DOLGENCORP INC]	4	Current NDC, Legacy NDC, 8 package rows	20250130_51e49a00-e040-4e7b-838c-c77ed75a7f92.zip

Products#

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

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

dg health naproxen sodium
Naproxen Sodium
NAPROXEN
FD&C BLUE NO. 2 ALUMINUM LAKE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55910-729	55910-729-62, 55910-729-71, 55910-729-78, 55910-729-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NAPROXEN SODIUM	9TN87S3A3C	ACTIB
FD&C BLUE NO. 2 ALUMINUM LAKE	4AQJ3LG584	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

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-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.

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	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.

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
dg health naproxen sodium	NAPROXEN SODIUM	Dolgencorp Inc	51e49a00-e040-4e7b-838c-c77ed75a7f92	2025-01-22	Warnings	Exact identifier ndc (package): 55910-729-71 ndc (package): 55910-729-75 ndc (package): 55910-729-62 ndc (package): 55910-729-78 ndc (product): 55910-729 ndc11 (package): 55910072962 ndc11 (package): 55910072975 ndc11 (package): 55910072978 ndc11 (package): 55910072971 spl id: 0c874a73-b144-40d7-bb3f-cb11f5cec8e5 spl set id: 51e49a00-e040-4e7b-838c-c77ed75a7f92

Reported adverse events (FAERS/openFDA)#

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