Sudafed PE Congestion

Product NDC: 50580-546
11-digit product format: 505800546
Labeler code: 50580
Product ID: 50580-546_da52fc7a-771b-ad90-e053-2a95a90a3ca3
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-07-13
Marketing end: 0000-00-00
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50580-546		D	Discontinued by firm	2026-10-05
excluded package	package	50580-546	50580-546-50	D	Discontinued by firm	2026-10-05
excluded package	package	50580-546	50580-546-51	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 · 36 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	50580-546-51	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50580-546-50	`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	50580-546-51	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50580-546-50	`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	50580-546-51	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50580-546-50	`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	50580-546-51	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50580-546-50	`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	50580-546-51	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50580-546-50	`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	50580-546-51	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50580-546-50	`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	50580-546-51	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50580-546-50	`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	50580-546-51	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50580-546-50	`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	50580-546-51	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50580-546-50	`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	50580-546-51	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50580-546-50	`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	50580-546-51	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50580-546-50	`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	50580-546-51	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50580-546-50	`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
50580-546-50	EA - Each	50580-546	5c8d7237-63a5-4368-9e3e-0de4073ff126	1	2016-10-06
50580-546-51	EA - Each	50580-546	ca9fc025-d4bb-451d-be9e-f328cf7b7e28	1	2017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
D&C yellow no. 10	INACTIVE INGREDIENT	35SW5USQ3G	SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
powdered cellulose	INACTIVE INGREDIENT	SMD1X3XO9M	SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
sodium starch glycolate Type A potato	INACTIVE INGREDIENT	5856J3G2A2	SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-546-50	50580054650	1 BLISTER PACK in 1 CARTON (50580-546-50) > 18 TABLET in 1 BLISTER PACK	1 blister pack	2015-07-13	0000-00-00	No	No	Current
50580-546-51	50580054651	2 BLISTER PACK in 1 CARTON (50580-546-51) > 18 TABLET in 1 BLISTER PACK	2 blister pack	2015-07-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SUDAFED PE ® CONGESTION	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	2022-03-16	HUMAN OTC DRUG LABEL	6