Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu

Product NDC: 69842-462
11-digit product format: 698420462
Labeler code: 69842
Product ID: 69842-462_b417d1de-3020-4a0b-8589-a4612acd9957
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form: KIT
Labeler: CVS Pharmacy
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-04-30
Marketing end: 2027-01-30
NDC exclude flag: No
Current FDA listing: Yes

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 · 26 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
2025-04-01 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	69842-462-12	`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	69842-462-12	`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	69842-462-12	`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	69842-462-12	`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	69842-462-12	`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	69842-462-12	`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	69842-462-12	`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	69842-462-12	`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	69842-462-12	`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	69842-462-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69842-462-12	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69842-462-12	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69842-462-12	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu
Brand name suffix: Maximum Strength

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1043543	Internal RxNorm lookup
1375932	Internal RxNorm lookup
2637728	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
91c803c8-6cf8-4ff6-b376-ea6d65f9f227	Available on FDA.report

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
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
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
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
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
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
76633df9-0d59-4b88-03ed-21dee1b966f8	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69842-462-12	2025-07-01	C162847	48780-1	f386c64a-3a8d-0266-e053-dadaa90a7c1a	Drug Facts
69842-462-12	2023-01-30	C162847	48780-1	f386c64a-3a8d-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69842-462-12	Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and FluMaximum Strength	1 in 1 KIT	KIT	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69842-462	DAYTIME MUCUS RELIEF SEVERE CONGESTION AND COUGH AND NIGHTTIME COLD AND FLU MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	2	Current NDC, Legacy NDC, 1 package rows	20191101_91c803c8-6cf8-4ff6-b376-ea6d65f9f227.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 33 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Childrens Cough and Chest Congestion Mini-Melts Orange Creme	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	66543190-1d3d-4259-ae73-d366ecbf9e52	2026-05-12	Warnings	Exact identifier application number: M012
basic care daytime nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	612719a9-fa2e-4c40-8f35-a399aeaafecc	2026-05-12	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain Daytime Nighttime Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	3cac44ad-1835-487e-b6d0-1483d724bb5e	2026-05-12	Warnings	Exact identifier application number: M012
GUAIFENESIN DM	GUAIFENESIN AND DEXTROMETHORPHAN	Cardinal Health 107, LLC	9cfb1abb-98c4-4e90-8dd7-fcffc112f988	2026-05-12	Warnings	Exact identifier application number: M012
Nasal Decongestant PE and Pain Relief Maximum Strength	ACETAMINOPHEN, PHENYLEPHRINE HCL	WinCo Foods, LLC	fab51b36-1c2e-4c97-932c-dacfaf55935a	2026-05-11	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Walgreen Company	cad5da8c-65a6-44c4-a4c7-38f2c7fe43aa	2026-05-11	Warnings	Exact identifier application number: M012
NebuClear MD	SALINE	Blue Echo Care LLC	3f85fe62-230f-b0f1-e063-6394a90a5cb8	2026-05-11	Warnings	Exact identifier application number: M012
Device - NebuClear MD Hand-held Rubber Bulb Nebulizer	DEVICE - HAND-HELD RUBBER BULB NEBULIZER	Blue Echo Care LLC	43e0a646-be57-1024-e063-6394a90a43e4	2026-05-11	Warnings	Exact identifier application number: M012
Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	1efd1778-7ab1-4797-98c5-4637940ee3ec	2026-05-11	Warnings	Exact identifier application number: M012
DayTime High Blood Pressure Cold and Flu Relief Liquid filled Softgels	ACETAMINOPHEN,DEXTROMETHROPHAN HBR	AptaPharma Inc.	0380035e-44d5-44ea-9d1c-d57a1de65188	2026-05-10	Warnings	Exact identifier application number: M012
Night Time Cold and Flu relief liquid filled softgels	ACETAMINOPHEN,DEXTROMETHROPHAN HBR,DOXYLAMINE SUCCINATE	AptaPharma Inc.	d61e2186-8b59-45f9-96ec-83430a0fe0cb	2026-05-10	Warnings	Exact identifier application number: M012
Maximum Strength Tussin DM Liquid filled Softgels	DEXTROMETHORPHAN HBR, GUAIFENESIN	AptaPharma Inc.	39ad6cc9-d2b0-4b4a-8aa3-977905c9e6f1	2026-05-10	Warnings	Exact identifier application number: M012
Day-Time Cold/Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	AptaPharma Inc.	c0dc613c-7f4e-4733-b2b6-6ba20e8fb83c	2026-05-10	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief Liquid Filled Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	AptaPharma Inc.	c078efb5-d30e-4dd1-a600-6e827390df76	2026-05-10	Warnings	Exact identifier application number: M012
DM Max CONGESTION and COUGH	DEXTROMETHORPHAN HBR, GUAIFENESIN	DeMoulas Market Basket	b12e26b2-79e4-45a5-9a90-4630f92457d0	2026-05-09	Warnings	Exact identifier application number: M012
Flu HBP Maximum Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Walgreen Company	fac55d76-457f-4258-9cc8-6edae539cada	2026-05-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	HyVee Inc	5a0ef8ae-f6d5-4388-b4da-6b7f025160b2	2026-05-08	Warnings	Exact identifier application number: M012
Halls Variety Pack Mentholyptus Honey Lemon Cherry	MENTHOL	Mondelez Global LLC	512a9a2e-6160-80d1-e063-6394a90aeff0	2026-05-08	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5150ff85-85bb-9cd9-e063-6294a90a1144	2026-05-08	Warnings	Exact identifier application number: M012
Dr. Simi Children s Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	Farmacias De Similares TX LLC	5151740a-8270-7bb5-e063-6294a90ae387	2026-05-08	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2637728	{1 (acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack	GPCK	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	3
2637728	1 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution) Pack	PSN	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	3
1375932	acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution	PSN	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	3
1043543	dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	3
1375932	acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	3
1043543	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	3
2637728	1 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) Pack	SY	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	3
1375932	acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	3
1375932	acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution	SY	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	3
1375932	APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution	SY	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	3
1375932	APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	3
1375932	APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution	SY	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	3
1043543	dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution	SY	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	3
1043543	dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution	SY	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69842-462-12	69842046212	1 KIT in 1 KIT (69842-462-12) * 177 mL in 1 BOTTLE, PLASTIC * 177 mL in 1 BOTTLE, PLASTIC	1 kit	2018-04-30	2027-01-30	No	No	Current