Sudafed 12 Hour

Manufacturer: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Effective date: 2017-07-19
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: legacy-cache
Hydrated at: 2026-08-02 01:14:51

Label at a glance#

ProductSudafed 12 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 temporarily relieves sinus congestion and pressure

Dosage and administration

adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age

Storage and handling

store at 59° to 77°F in a dry place. Protect from light do not use if carton is opened or if blister unit is broken see side panel for lot number and expiration date

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-217-2117

PhoneLabel contact215-273-8755

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Pseudoephedrine HCl 120 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
temporarily relieves sinus congestion and 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

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

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	take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours
children under 12 years	do not use this product in children under 12 years of age

Other information

STORAGE AND HANDLING SECTION

store at 59° to 77°F in a dry place. Protect from light
do not use if carton is opened or if blister unit is broken
see side panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

candelilla wax, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SINUS

NDC 50580-670-20

SUDAFED^®
12 HOUR

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

SINUS PRESSURE
+ CONGESTION

Pseudoephedrine
HCl

MAXIMUM
STRENGTH

NON-DROWSY

20 COATED CAPLETS*
120 mg EACH

*CAPSULE-SHAPED TABLETS
‡Actual Pill Size

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-670-10	EA - Each	50580-670	e1e7de32-09d8-420b-b9bd-2710401a1d40	1	2012-07-24
50580-670-20	EA - Each	50580-670	c0d26ab6-3bf3-49e1-9bde-94e7db65ab03	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Pseudoephedrine hydrochloride	ACTIVE INGREDIENT	6V9V2RYJ8N	8
Pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	8
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	8
candelilla wax	INACTIVE INGREDIENT	WL0328HX19	8
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	8
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	8
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	8
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	8
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	8
povidones	INACTIVE INGREDIENT	FZ989GH94E	8
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	8
shellac	INACTIVE INGREDIENT	46N107B71O	8
talc	INACTIVE INGREDIENT	7SEV7J4R1U	8
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	8

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Sudafed 12 Hour
Pseudoephedrine hydrochloride
Pseudoephedrine
candelilla wax
FD&C blue no. 1
aluminum oxide
HYPROMELLOSE, UNSPECIFIED
magnesium stearate
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
propylene glycol
shellac
talc
titanium dioxide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50580-670	50580-670-10, 50580-670-30, 50580-670-20

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
Pseudoephedrine hydrochloride	6V9V2RYJ8N	ACTIB
candelilla wax	WL0328HX19	IACT
FD&C blue no. 1	H3R47K3TBD	IACT
aluminum oxide	LMI26O6933	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
magnesium stearate	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
propylene glycol	6DC9Q167V3	IACT
shellac	46N107B71O	IACT
talc	7SEV7J4R1U	IACT
titanium dioxide	15FIX9V2JP	IACT

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 6 · 336 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
candelilla wax	CANDELILLA WAX	WL0328HX19	TABLET / ORAL		4 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
shellac	SHELLAC	46N107B71O	FILM / SUBLINGUAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	GUM, CHEWING / BUCCAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SOLUTION / ORAL	0.04 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	TABLET, ORALLY DISINTEGRATING / ORAL	15.03 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
shellac	SHELLAC	46N107B71O	CAPSULE / ORAL	34.48 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	GRANULE / ORAL		322 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	17 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, LIQUID FILLED / ORAL	0.08 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
shellac	SHELLAC	46N107B71O	TABLET, FILM COATED / ORAL	4.4 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	INSERT, EXTENDED RELEASE / OPHTHALMIC	0.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 27 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 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	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
povidones	POVIDONE	FZ989GH94E	SOLUTION / ORAL		3000 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 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 44.

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
A073585-001	SUDAFED 12 HOUR	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL			1991-10-31

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1991-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1991-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1991-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1991-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1991-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1991-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1991-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1991-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1991-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1991-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1991-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1991-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL	RS	1991-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073585-001	SUDAFED 12 HOUR	120MG	TABLET, EXTENDED RELEASE / ORAL		1991-10-31	`3a93d1ddd44b…`

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
f6cc4ab8-ce62-4811-a55e-ace614fee4b8			a110069f-dd9e-45ad-b7db-c5a6be1a1564	2017-07-19	Warnings	Exact identifier spl id: f6cc4ab8-ce62-4811-a55e-ace614fee4b8 spl set id: a110069f-dd9e-45ad-b7db-c5a6be1a1564

Reported adverse events (FAERS/openFDA)#

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