Mucinex Fast-Max Day Time Severe Cold and Mucinex Fast-Max Night Time Cold and Flu

Product NDC: 63824-526
11-digit product format: 638240526
Labeler code: 63824
Product ID: 63824-526_839cef10-acb1-4902-9cb2-c7806bf2cdeb
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form: KIT
Labeler: Reckitt Benckiser LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-04-11
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63824-526		D	Discontinued by firm		2026-10-05
excluded package	package	63824-526	63824-526-22	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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63824-526-22	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63824-526-22	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63824-526-22	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63824-526-22	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63824-526-22	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63824-526-22	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63824-526-22	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63824-526-22	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63824-526-22	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63824-526-22	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63824-526-22	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63824-526-22	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63824-526-22	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63824-526-22	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63824-526-22	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63824-526-22	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63824-526-22	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63824-526-22	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63824-526-22	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63824-526-22	2023-09-07	C162847	48780-1	9d75b9d0-1c24-f424-e053-dadaa90a57ce	Mucinex® Fast-Max ® Day Time Severe Cold and Mucinex® Fast-Max ® Night Time Cold and Flu Maximum Strength
63824-526-22	2020-01-31	C162847	48780-1	9d75b9d0-1c24-f424-e053-dadaa90a57ce	Mucinex® Fast-Max ® Day Time Severe Cold and Mucinex® Fast-Max ® Night Time Cold and Flu Maximum Strength

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-526-22	ML - Milliliter	63824-526	306f820d-c42c-4c07-bcb5-b4ec8d296da6	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
Diphenhydramine Hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
Guaifenesin	ACTIVE MOIETY	495W7451VQ	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
propyl gallate	INACTIVE INGREDIENT	8D4SNN7V92	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
sorbitol	INACTIVE INGREDIENT	506T60A25R	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
trisodium citrate dihydrate	INACTIVE INGREDIENT	B22547B95K	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
water	INACTIVE INGREDIENT	059QF0KO0R	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]	2