Mucinex Sinus-Max

Product NDC: 63824-204
11-digit product format: 638240204
Labeler code: 63824
Product ID: 63824-204_106ccf9f-c27d-4700-9f86-b50abbd7ed34
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Diphenhydramine Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride
Dosage form: KIT
Labeler: RB Health (US) LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2020-06-01
Marketing end: 0000-00-00
Active strength: 0
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63824-204		D	Discontinued by firm	2026-10-05
excluded product	product	63824-204		D	Discontinued by firm	2026-10-05
excluded package	package	63824-204	63824-204-20	D	Discontinued by firm	2026-10-05
excluded package	package	63824-204	63824-204-40	D	Discontinued by firm	2026-10-05
excluded package	package	63824-204	63824-204-10	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 · 39 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63824-204-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63824-204-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63824-204-40	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63824-204-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63824-204-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63824-204-40	`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	63824-204-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63824-204-20	`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	63824-204-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63824-204-20	`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	63824-204-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63824-204-20	`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	63824-204-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63824-204-20	`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	63824-204-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63824-204-20	`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	63824-204-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63824-204-20	`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	63824-204-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63824-204-20	`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	63824-204-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63824-204-20	`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	63824-204-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63824-204-20	`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	63824-204-10	`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
63824-204-40	EA - Each	63824-204	c3243277-c3ec-4646-8de1-c5d1e0e6233b	1	2021-09-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
Diphenhydramine Hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
crospovidone (15 mpa.s at 5%)	INACTIVE INGREDIENT	68401960MK	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
FD&C blue no. 2	INACTIVE INGREDIENT	L06K8R7DQK	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
methacrylic acid - ethyl acrylate copolymer (1:1) Type A	INACTIVE INGREDIENT	NX76LV5T8J	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
mica	INACTIVE INGREDIENT	V8A1AW0880	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
povidone K29/32	INACTIVE INGREDIENT	390RMW2PEQ	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
povidones	INACTIVE INGREDIENT	FZ989GH94E	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63824-204	MUCINEX SINUS-MAX DAY NIGHT (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC]	9	Legacy NDC	20230825_ae33d924-9262-41f6-964f-d8b567b3d903.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63824-204-10	63824020410	1 KIT in 1 CARTON (63824-204-10) * 1 BLISTER PACK in 1 CARTON > 6 TABLET, COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON > 4 TABLET, COATED in 1 BLISTER PACK	1 kit	2020-06-01	0000-00-00	No	No	Current
63824-204-20	63824020420	1 KIT in 1 CARTON (63824-204-20) * 6 TABLET, COATED in 1 BLISTER PACK * 4 TABLET, COATED in 1 BLISTER PACK	1 kit	2015-08-25	0000-00-00	No	No	Current
63824-204-40	63824020440	4 KIT in 1 CARTON (63824-204-40) > 1 KIT in 1 KIT * 6 TABLET, COATED in 1 BLISTER PACK * 4 TABLET, COATED in 1 BLISTER PACK	4 kit	2020-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mucinex® Sinus-Max® Day Night Maximum Strength	RB Health (US) LLC	2023-10-17	HUMAN OTC DRUG LABEL	3
Mucinex® Sinus-Max® Day Night Maximum Strength	RB Health (US) LLC \| RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD	2023-08-24	HUMAN OTC DRUG LABEL	9