MAXIMUM STRENGTH COLD AND FLU

Product NDC: 69842-789
11-digit product format: 698420789
Labeler code: 69842
Product ID: 69842-789_4cf6407c-3c2f-9d08-e063-6394a90a2673
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN,PHENYLEPHRINE HYDROCHLORIDE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: CVS Pharmacy, Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-07-10
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN
Active strength: 325; 10; 5; 200 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 6 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
2025-02-02 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	69842-789-16	`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	69842-789-16	`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	69842-789-16	`0efc9e666f02…`	`f202fb6c5f17…`

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: MAXIMUM STRENGTH COLD AND FLU
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1
GUAIFENESIN	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1656815	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
c0b36e4d-3667-58f6-e053-2a95a90afad7	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
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
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
42f3c020-f1b3-89bc-7bdc-e1f10e680485	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
69842-789-16	2025-02-13	C162847	48780-1	2cef2736-9d3b-d83d-e063-dadaa90ab31f	628T CVS 69842 789 ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN,PHENYLEPHRINE HYDROCHLORIDE 16CT
69842-789-16	2025-01-30	C162847	48780-1	2cef2736-9d3b-d83d-e063-dadaa90ab31f	628T CVS 69842 789 ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN,PHENYLEPHRINE HYDROCHLORIDE 16CT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69842-789-16	MAXIMUM STRENGTH COLD AND FLU	8 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	8		4
69842-789-16	MAXIMUM STRENGTH COLD AND FLU	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69842-789-16	EA - Each	69842-789	212acad7-b793-4793-8e6e-585f244dd153	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69842-789	MAXIMUM STRENGTH COLD AND FLU (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN,PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC]	3	Current NDC, Legacy NDC, 2 package rows	20250215_c0b36e4d-3667-58f6-e053-2a95a90afad7.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 32 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	a401eb92-60b6-427d-a677-29371a3150be	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	3ff4c4ea-7628-4d2b-a6e9-d994c25baef4	2026-05-12	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d7c18e95-8d7b-4550-9a20-fc704a114adb	2026-05-12	Warnings	Exact identifier application number: M012
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1656815	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	c0b36e4d-3667-58f6-e053-2a95a90afad7	4
1656815	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	c0b36e4d-3667-58f6-e053-2a95a90afad7	4
1656815	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule	SY	c0b36e4d-3667-58f6-e053-2a95a90afad7	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69842-789-16	69842078916	1 BLISTER PACK in 1 CARTON (69842-789-16) / 8 BLISTER PACK in 1 BLISTER PACK / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	1 blister pack	2021-07-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MAXIMUM STRENGTH COLD AND FLU	CVS Pharmacy, Inc \| TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LIMITED	2026-03-14	HUMAN OTC DRUG LABEL	4