Sudafed

Manufacturer: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Effective date: 2022-03-21
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 22:04:48

Label at a glance#

ProductSudafed 24 Hour

Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages relieves sinus pressure

Dosage and administration

adults and children 12 years and over swallow one whole tablet with water every 24 hours do not exceed one tablet in 24 hours do not divide, crush, chew or dissolve the tablet the tablet does not completely dissolve and may be seen in the stool (this is normal) children under 12 years do not use this product in children under 12 years of age

Storage and handling

each tablet contains: sodium 10 mg store at 15° to 25°C (59° to 77°F) in a dry place. do not use if carton is opened or if individual blister seals are broken or opened see side panel for lot number and expiration date

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-217-2117

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Pseudoephedrine HCl 240 mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
reduces swelling of nasal passages
relieves sinus pressure

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
had obstruction or narrowing of the bowel. Rarely, tablets of this kind may cause bowel obstruction (blockage), usually in people with severe narrowing of the bowel (esophagus, stomach or intestine).

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever
you experience persistent abdominal pain or vomiting

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over	swallow one whole tablet with water every 24 hours do not exceed one tablet in 24 hours do not divide, crush, chew or dissolve the tablet the tablet does not completely dissolve and may be seen in the stool (this is normal)
children under 12 years	do not use this product in children under 12 years of age

Other information

STORAGE AND HANDLING SECTION

each tablet contains: sodium 10 mg
store at 15° to 25°C (59° to 77°F) in a dry place.
do not use if carton is opened or if individual blister seals are broken or opened
see side panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose triacetate, hydroxypropylcellulose, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, propylene glycol, shellac, sodium chloride, and titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-888-217-2117

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SINUS

NDC 50580-669-10

SUDAFED^®
24 HOUR

Pseudoephedrine HCl Extended-Release Tablets,
Long-Acting Nasal Decongestant

SINUS PRESSURE
+ CONGESTION

Pseudoephedrine
HCl

MAXIMUM
STRENGTH

10 TABLETS
240 mg EACH
‡ Actual Pill Size

NON-DROWSY

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50580-669-10	2022-11-25	C162847	48780-1	e4f33bdf-a3df-d8a0-e053-dadaa90a6e4e	SUDAFED ® 24 HOUR
50580-669-10	2022-07-29	C162847	48780-1	e4f33bdf-a3df-d8a0-e053-dadaa90a6e4e	SUDAFED ® 24 HOUR

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-669-10	EA - Each	50580-669	ac0f2535-ad5a-47cf-a13a-16adf6c364cb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Pseudoephedrine Hydrochloride	ACTIVE INGREDIENT	6V9V2RYJ8N	1
pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	1
cellulose acetate	INACTIVE INGREDIENT	3J2P07GVB6	1
hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	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 · 15 matching rows.

Sudafed 24 Hour
Pseudoephedrine Hydrochloride
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
FERROSOFERRIC OXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
SODIUM CHLORIDE
TITANIUM DIOXIDE
PSEUDOEPHEDRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50580-669	50580-669-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDROXYPROPYL CELLULOSE, UNSPECIFIED	9XZ8H6N6OH	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	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 7 · 378 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / ENDOTRACHEAL		68 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	ELIXIR / ORAL	1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	GEL / RECTAL		348 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / SUBLINGUAL	0.08 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBMUCOSAL	16 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	JELLY / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
hydroxypropyl cellulose	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	CAPSULE, DELAYED RELEASE / ORAL		150 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET / ORAL		231 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / VAGINAL	0.4 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		24 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	GRANULE / ORAL		45 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
hydroxypropyl cellulose	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	CAPSULE, COATED PELLETS / ORAL	41.4 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / EPIDURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PARENTERAL		584 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	SUSPENSION/ DROPS / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
povidone	POVIDONE	FZ989GH94E	POWDER, FOR SUSPENSION / ORAL	35 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	8 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRABURSAL	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
hydroxypropyl cellulose	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	SUSPENSION / ORAL		100 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER, DENTIFRICE / DENTAL	0.03 mg/mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / TOPICAL	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	GRANULE, FOR SUSPENSION / ORAL	1.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, CHEWABLE / ORAL		20 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SOLUTION / OPHTHALMIC	0.9 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	ENEMA / RECTAL	0.01 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAMUSCULAR	4 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	EMULSION / OPHTHALMIC		26 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		45 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
cellulose acetate	CELLULOSE ACETATE	3J2P07GVB6	TABLET, EXTENDED RELEASE / ORAL		187 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 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
N020021-002	SUDAFED 24 HOUR	PSEUDOEPHEDRINE HYDROCHLORIDE	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1992-12-15

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	N020021-002	SUDAFED 24 HOUR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020021-002	SUDAFED 24 HOUR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`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
ee30c3f8-6340-bb78-e053-2a95a90aabdf			9991599a-b49b-4ea6-a6e1-c05f0c992f71	2022-11-23	Warnings	Exact identifier spl set id: 9991599a-b49b-4ea6-a6e1-c05f0c992f71

Reported adverse events (FAERS/openFDA)#

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