SUDAFED

Product NDC: 50580-545
11-digit product format: 505800545
Labeler code: 50580
Product ID: 50580-545_0243c7ca-77fa-4189-bce2-ada15361b6cb
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-10-01
Marketing end: 0000-00-00
Substance: PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 30 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50580-545		D	Discontinued by firm	2026-10-05
excluded package	package	50580-545	50580-545-24	D	Discontinued by firm	2026-10-05
excluded package	package	50580-545	50580-545-48	D	Discontinued by firm	2026-10-05
excluded package	package	50580-545	50580-545-72	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50580-545-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50580-545-48	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50580-545-72	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50580-545-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50580-545-48	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50580-545-72	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50580-545-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50580-545-48	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50580-545-72	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50580-545-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50580-545-48	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50580-545-72	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50580-545-24	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50580-545-48	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50580-545-72	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50580-545-24	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50580-545-48	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50580-545-72	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50580-545-24	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50580-545-48	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50580-545-72	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50580-545-24	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50580-545-48	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50580-545-72	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50580-545-24	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50580-545-48	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50580-545-72	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50580-545-24	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50580-545-48	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50580-545-72	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50580-545-24	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50580-545-48	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50580-545-72	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50580-545-24	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50580-545-48	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50580-545-72	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-545-24	EA - Each	50580-545	cd677fe9-95be-4625-bc0c-58943393a1be	1	2012-07-24
50580-545-48	EA - Each	50580-545	725f3f12-d026-4735-93cb-abb90b9f1555	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Pseudoephedrine Hydrochloride	ACTIVE INGREDIENT	6V9V2RYJ8N	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
Pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
D&C yellow NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
FD&C red NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
FD&C yellow NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
shellac	INACTIVE INGREDIENT	46N107B71O	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SUDAFED (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-545-24	50580054524	3 BLISTER PACK in 1 CARTON (50580-545-24) > 8 TABLET, COATED in 1 BLISTER PACK	3 blister pack	2015-07-13	0000-00-00	No	No	Current
50580-545-48	50580054548	6 BLISTER PACK in 1 CARTON (50580-545-48) > 8 TABLET, COATED in 1 BLISTER PACK	6 blister pack	2015-07-13	0000-00-00	No	No	Current
50580-545-72	50580054572	3 CARTON in 1 PACKAGE (50580-545-72) > 3 BLISTER PACK in 1 CARTON (50580-545-24) > 8 TABLET, COATED in 1 BLISTER PACK	3 carton	2016-02-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SUDAFED ®	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	2019-12-06	HUMAN OTC DRUG LABEL	6