Sunmark Sinus and Cold D

Manufacturer: Strategic Sourcing Services LLC
Effective date: 2020-09-01
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: legacy-cache
Hydrated at: 2026-08-01 23:16:17

Label at a glance#

ProductSunmark Sinus and Cold D

Active ingredientNAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE

Label structure8 sections

Indications and uses

temporarily relieves these cold, sinus, and flu symptoms: • sinus pressure • minor body aches and pains • headache • nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) • fever

Dosage and administration

• do not take more than directed • the smallest effective dose should be used • swallow whole; do not crush or chew • drink a full glass of water with each dose • adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours • children under 12 years: do not use • each caplet contains: sodium 21 mg • meets USP Dissolution Test 2 • store at 20-25°C (68-77°F) • store in...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-719-9260

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

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

Pseudoephedrine HCl 120 mg, extended-release

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these cold, sinus, and flu symptoms:

sinus pressure
minor body aches and pains
headache
nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)
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
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
in children under 12 years of age

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, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, 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 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
redness or swelling is present in the painful area
any new symptoms appear
fever gets worse or lasts more than 3 days
you have difficulty swallowing or the caplet feels stuck in your throat
you get nervous, dizzy, or sleepless
nasal congestion lasts more than 7 days

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 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.

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
swallow whole; do not crush or chew
drink a full glass of water with each dose
adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours
children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

each caplet contains: sodium 21 mg
meets USP Dissolution Test 2
store at 20-25°C (68-77°F)
store in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO ALEVE-D^® SINUS & COLD

ACTIVE INGREDIENTS

sinus & cold-D

Naproxen sodium 220 mg

Pseudoephedrine hydrochloride 120 mg

Extended-release tablet

Pain reliever/Fever reducer (NSAID)

Nasal decongestant

12-hour multi-symptom relief of Sinus pressure, Headache, Sinus congestion, Nasal congestion & Body aches

1 Caplet - 12 hours

NON-DROWSY

Actual Size

GLUTEN FREE

10 CAPLETS**

**Capsule-Shaped Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-393-01	EA - Each	49348-393	700c12f5-bdf4-48be-9436-964b64dd6166	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	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 · 16 matching rows.

Sunmark Sinus and Cold D
Naproxen sodium, Pseudoephedrine HCl
NAPROXEN SODIUM
NAPROXEN
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE, UNSPECIFIED
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49348-393	49348-393-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NAPROXEN SODIUM	9TN87S3A3C	ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML · Source PDF

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 7 · 364 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE / ORAL		29520 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER, FOR SUSPENSION / ORAL		396 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, ORALLY DISINTEGRATING / ORAL		41 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	9.5 %w/v		Exact identifier — unii candidate 38 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / INTRAMUSCULAR		150 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, CHEWABLE / ORAL	11.8 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / AURICULAR (OTIC)	0.2 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / SUBCUTANEOUS		98 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	EMULSION / OPHTHALMIC		26 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / SUBLINGUAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, DELAYED RELEASE / ORAL		79 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 27 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GEL / TOPICAL		12 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	ELIXIR / ORAL	4.5 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION, EXTENDED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, DELAYED RELEASE / ORAL	789.6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	INSERT / VAGINAL	54.21 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, FOR SUSPENSION / ORAL	2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, COATED / ORAL		1301 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		350 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE / ORAL		1488 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, ORALLY DISINTEGRATING / ORAL	15.03 mg		Exact identifier — unii candidate 30 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
A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		RS	2004-03-17

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG BASE;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG BASE;120MG	TABLET, EXTENDED RELEASE / ORAL		2004-03-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076518-001	NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG	TABLET, EXTENDED RELEASE / ORAL	RS	2004-03-17	`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
a2c15a9a-0218-493a-bd6e-56c3dd87bf82			c09e8374-aa5c-4a0d-9073-58bf63a2e201	2020-09-01	Warnings	Exact identifier spl id: a2c15a9a-0218-493a-bd6e-56c3dd87bf82 spl set id: c09e8374-aa5c-4a0d-9073-58bf63a2e201

Reported adverse events (FAERS/openFDA)#

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