CVS Severe Congestion and Pain Relief

Product NDC: 69842-717
11-digit product format: 698420717
Labeler code: 69842
Product ID: 69842-717_e8ea3a44-7cbf-4c7d-af74-f95ae1e2ed9c
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form: SOLUTION
Route: ORAL
Labeler: CVS
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-03-30
Substance: ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 650; 400; 10 mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: CVS Severe Congestion and Pain Relief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/20mL
GUAIFENESIN	400 mg/20mL
PHENYLEPHRINE HYDROCHLORIDE	10 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1116568	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
5a8e4320-bae1-4831-b66b-9babfe8888d6	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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69842-717-06	CVS Severe Congestion and Pain Relief	180 mL in 1 BOTTLE	SOLUTION	180		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69842-717	CVS SEVERE CONGESTION AND PAIN RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS]	6	Current NDC, Legacy NDC, 1 package rows	20240823_5a8e4320-bae1-4831-b66b-9babfe8888d6.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 56 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SEVERE DAYTIME COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens	ca3c1eb4-6099-5e5f-e053-2995a90ab61b	2026-01-19	Warnings	Exact identifier application number: M012
SEVERE NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	WALGREENS	fe6dff90-18f1-491e-84b9-cc74bb1831ba	2026-01-19	Warnings	Exact identifier application number: M012
Daytime Non-Drowsy Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens Company	ec8c73d5-b190-432a-92c6-68ea0fc86ea6	2026-01-19	Warnings	Exact identifier application number: M012
Walgreens NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREEN COMPANY	5bf72e2f-15c8-466a-9e13-50654233da91	2026-01-19	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime, Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreens	9862f84d-1c18-4ef7-86dc-98572599d417	2026-01-19	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	37853689-c9ca-4bc7-9c5b-4a68b8d778be	2026-01-19	Warnings	Exact identifier application number: M012
VAPORX	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	AKRON PHARMA INC	51b32162-0c5a-4b5b-999a-34337d816603	2026-01-19	Warnings	Exact identifier application number: M012
Equate	OXYMETAZOLINE HCL	Walmart Inc	2f762c24-2442-506a-e063-6394a90a3b96	2026-01-19	Warnings	Exact identifier application number: M012
Dimetane	DIPHENHYDRAMINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f	2026-01-19	Warnings	Exact identifier application number: M012
nitetime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Publix Super Markets Inc	f681d986-9838-42d8-8ed9-732a39fbf870	2026-01-19	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	H E B	22d241c5-a3fd-4619-8147-91d7a4c8cf98	2026-01-19	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength	PSEUDOEPHEDRINE HCL	Better Living Brands, LLC	9fe63ca6-3863-4175-9aec-ecd6ebbdb249	2026-01-19	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Night Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amerisource Bergen	5749ce9d-e182-478f-ab88-b520a35a99a7	2026-01-19	Warnings	Exact identifier application number: M012
Foster and Thrive Daytime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Strategic Sourcing Services LLC	1d9150b1-2f6c-4c33-8c93-3ed1d88585e2	2026-01-18	Warnings	Exact identifier application number: M012
HealthWise Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Veridian Healthcare	ce3ceffd-3ff5-3795-e053-2995a90a827f	2026-01-18	Warnings	Exact identifier application number: M012
topcare nite time cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Topco Associates LLC	31210a95-f9dc-49db-aab5-25c4dca49266	2026-01-17	Warnings	Exact identifier application number: M012
Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Procter & Gamble Manufactura S de RL de CV	f77226c0-b6d5-9fd0-e053-6294a90a4b57	2026-01-16	Warnings	Exact identifier application number: M012
Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Procter & Gamble Manufactura S de RL de CV	f691734b-5cf4-6eb8-e053-2a95a90aee80	2026-01-16	Warnings	Exact identifier application number: M012
Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Procter & Gamble Manufactura S de RL de CV	f771aa19-295a-9f4e-e053-6294a90a1674	2026-01-16	Warnings	Exact identifier application number: M012
CVS Cherry Cough Drops	MENTHOL	CVS Pharmacy	de5c4b94-0420-5d43-e053-2995a90aa5a5	2026-01-16	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
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1116568	acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution	PSN	5a8e4320-bae1-4831-b66b-9babfe8888d6	7
1116568	acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	5a8e4320-bae1-4831-b66b-9babfe8888d6	7
1116568	acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	5a8e4320-bae1-4831-b66b-9babfe8888d6	7
1116568	acetaminophen 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution	SY	5a8e4320-bae1-4831-b66b-9babfe8888d6	7
1116568	APAP 32.5 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution	SY	5a8e4320-bae1-4831-b66b-9babfe8888d6	7
1116568	APAP 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution	SY	5a8e4320-bae1-4831-b66b-9babfe8888d6	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69842-717-06	69842071706	180 mL in 1 BOTTLE (69842-717-06)	180 ml	2020-03-30	0000-00-00	No	No	Current