Sinus Decongestant

Product NDC: 0498-3331
11-digit product format: 004983331
Labeler code: 0498
Product ID: 0498-3331_d2ba32dd-deb9-3da8-e053-2a95a90aae78
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine
Dosage form: TABLET
Route: ORAL
Labeler: Honeywell Safety Products USA, Inc
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2018-09-18
Marketing end: 0000-00-00
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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	0498-3331		D	Discontinued by firm	2026-08-10
excluded package	package	0498-3331	0498-3331-10	D	Discontinued by firm	2026-08-10
excluded package	package	0498-3331	0498-3331-25	D	Discontinued by firm	2026-08-10
excluded package	package	0498-3331	0498-3331-50	D	Discontinued by firm	2026-08-10

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	0498-3331-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0498-3331-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0498-3331-10	`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	0498-3331-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0498-3331-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0498-3331-10	`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	0498-3331-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0498-3331-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0498-3331-10	`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	0498-3331-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0498-3331-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0498-3331-10	`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	0498-3331-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0498-3331-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0498-3331-10	`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	0498-3331-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0498-3331-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0498-3331-10	`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	0498-3331-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0498-3331-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0498-3331-10	`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	0498-3331-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0498-3331-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0498-3331-10	`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	0498-3331-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0498-3331-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0498-3331-10	`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	0498-3331-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0498-3331-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0498-3331-10	`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	0498-3331-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0498-3331-25	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0498-3331-10	`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	0498-3331-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0498-3331-25	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0498-3331-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	NORTH SINUS DECONGESTANT (PHENYLEPHRINE) TABLET [NORTH SAFETY PRODUCTS]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	NORTH SINUS DECONGESTANT (PHENYLEPHRINE) TABLET [NORTH SAFETY PRODUCTS]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	NORTH SINUS DECONGESTANT (PHENYLEPHRINE) TABLET [NORTH SAFETY PRODUCTS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NORTH SINUS DECONGESTANT (PHENYLEPHRINE) TABLET [NORTH SAFETY PRODUCTS]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NORTH SINUS DECONGESTANT (PHENYLEPHRINE) TABLET [NORTH SAFETY PRODUCTS]	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	NORTH SINUS DECONGESTANT (PHENYLEPHRINE) TABLET [NORTH SAFETY PRODUCTS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NORTH SINUS DECONGESTANT (PHENYLEPHRINE) TABLET [NORTH SAFETY PRODUCTS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NORTH SINUS DECONGESTANT (PHENYLEPHRINE) TABLET [NORTH SAFETY PRODUCTS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NORTH SINUS DECONGESTANT (PHENYLEPHRINE) TABLET [NORTH SAFETY PRODUCTS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NORTH SINUS DECONGESTANT (PHENYLEPHRINE) TABLET [NORTH SAFETY PRODUCTS]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	NORTH SINUS DECONGESTANT (PHENYLEPHRINE) TABLET [NORTH SAFETY PRODUCTS]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NORTH SINUS DECONGESTANT (PHENYLEPHRINE) TABLET [NORTH SAFETY PRODUCTS]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
1WS297W6MV	PHENYLEPHRINE	59-42-7	Phenylephrine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0498-3331-10	00498333110	100 PACKET in 1 BOTTLE (0498-3331-10) > 2 TABLET in 1 PACKET	100 packet	2018-09-18	0000-00-00	No	No	Current
0498-3331-25	00498333125	250 PACKET in 1 BOX (0498-3331-25) > 2 TABLET in 1 PACKET	250 packet	2018-09-18	0000-00-00	No	No	Current
0498-3331-50	00498333150	500 PACKET in 1 BOX (0498-3331-50) > 2 TABLET in 1 PACKET	500 packet	2018-09-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
4248 First Aid Kit	Honeywell Safety Products USA, INC	2021-12-23	HUMAN OTC DRUG LABEL	5
4356 First Aid Kit	Honeywell Safety Products USA, INC	2021-12-23	HUMAN OTC DRUG LABEL	3
4390 First Aid Kit	Honeywell Safety Products USA, INC	2021-12-13	HUMAN OTC DRUG LABEL	4
0498-3330 & 0498-0331: Sinus Decongestant	Honeywell Safety Products USA, Inc \| NORTH SAFETY DE MEXICALI, S. DE R.I. DE C.V.	2021-12-09	HUMAN OTC DRUG LABEL	13

Sinus Decongestant

NDC auxiliary status#

Observed NDC auxiliary status history#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#