Maximum Strength Mucinex Fast-Max Day Time Cold and Flu and Night Time Cold and Flu

Product NDC: 63824-511
Requested package NDC: 63824-511-20
11-digit product format: 638240511
Labeler code: 63824
Product ID: 63824-511_7bd732dd-213a-4768-9784-473c1e33d4bb
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and 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: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63824-511	63824-511-20	I	Inactivated by FDA		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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
63824-511-10	2022-01-28	d6a99b39-b26d-a426-e053-dadaa90af4c2	Maximum Strength Mucinex® Fast-Max ® Day Time Cold & Flu and Night Time Cold & Flu
63824-511-20	2022-01-28	d6a99b39-b26d-a426-e053-dadaa90af4c2	Maximum Strength Mucinex® Fast-Max ® Day Time Cold & Flu and Night Time Cold & Flu
63824-511-40	2022-01-28	d6a99b39-b26d-a426-e053-dadaa90af4c2	Maximum Strength Mucinex® Fast-Max ® Day Time Cold & Flu and Night Time Cold & Flu
63824-511-30	2021-01-29	ba0f9c33-3f15-a910-e053-dadaa90a0b85	Maximum Strength Mucinex® Fast-Max ® Day Time Cold & Flu and Night Time Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63824-511-10	Maximum Strength Mucinex Fast-Max Day Time Cold and Flu and Night Time Cold and Flu	1 in 1 CARTON	KIT	1	2
63824-511-20	Maximum Strength Mucinex Fast-Max Day Time Cold and Flu and Night Time Cold and Flu	1 in 1 KIT	KIT	1	2
63824-511-20	Maximum Strength Mucinex Fast-Max Day Time Cold and Flu and Night Time Cold and Flu	2 in 1 CARTON	KIT	2	2
63824-511-30	Maximum Strength Mucinex Fast-Max Day Time Cold and Flu and Night Time Cold and Flu	1 in 1 CARTON	KIT	1	2
63824-511-40	Maximum Strength Mucinex Fast-Max Day Time Cold and Flu and Night Time Cold and Flu	1 in 1 KIT	KIT	1	2
63824-511-40	Maximum Strength Mucinex Fast-Max Day Time Cold and Flu and Night Time Cold and Flu	4 in 1 CARTON	KIT	4	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-511-20	EA - Each	63824-511	069a828f-8245-4d5b-a60e-020876185846	1	2021-01-08
63824-511-30	EA - Each	63824-511	835bd8fa-edac-4a39-a047-e4170d7b8f43	1	2020-04-20
63824-511-40	EA - Each	63824-511	942eae50-9927-42aa-bff5-64ebc6ac02b4	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63824-511	MAXIMUM STRENGTH MUCINEX FAST-MAX DAY TIME COLD AND FLU AND NIGHT TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC]	2	Legacy NDC, 5 package rows	20201103_f7ef9731-282c-4494-9c31-0d0eb85bf187.zip
63824-511	MAXIMUM STRENGTH MUCINEX FAST-MAX DAY TIME COLD AND FLU AND NIGHT TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC]	2	Legacy NDC, 1 package rows	20191219_bc823ebb-a4c6-4467-a1e7-f3333e4fd5d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1110988	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	bc823ebb-a4c6-4467-a1e7-f3333e4fd5d3	2
1110988	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	f7ef9731-282c-4494-9c31-0d0eb85bf187	2
1233575	acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	bc823ebb-a4c6-4467-a1e7-f3333e4fd5d3	2
1233575	acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	f7ef9731-282c-4494-9c31-0d0eb85bf187	2
1110988	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	bc823ebb-a4c6-4467-a1e7-f3333e4fd5d3	2
1110988	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	f7ef9731-282c-4494-9c31-0d0eb85bf187	2
1233575	acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	bc823ebb-a4c6-4467-a1e7-f3333e4fd5d3	2
1233575	acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	f7ef9731-282c-4494-9c31-0d0eb85bf187	2
1233575	acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet	SY	bc823ebb-a4c6-4467-a1e7-f3333e4fd5d3	2
1233575	acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet	SY	f7ef9731-282c-4494-9c31-0d0eb85bf187	2
1110988	APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	bc823ebb-a4c6-4467-a1e7-f3333e4fd5d3	2
1110988	APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	f7ef9731-282c-4494-9c31-0d0eb85bf187	2
1233575	APAP 325 MG / Diphenhydramine Hydrochloride 12.5 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	bc823ebb-a4c6-4467-a1e7-f3333e4fd5d3	2
1233575	APAP 325 MG / Diphenhydramine Hydrochloride 12.5 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	f7ef9731-282c-4494-9c31-0d0eb85bf187	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63824-511-20	63824051120	2 KIT in 1 CARTON (63824-511-20) > 1 KIT in 1 KIT * 6 TABLET in 1 BLISTER PACK * 4 TABLET in 1 BLISTER PACK	2 kit	2020-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Maximum Strength Mucinex Fast-Max Day Time Cold and Flu	RB Health (US) LLC	2020-10-27	HUMAN OTC DRUG LABEL	2
Maximum Strength Mucinex Fast-Max Day Time Cold and Flu	RB Health (US) LLC	2019-12-17	HUMAN OTC DRUG LABEL	2