Severe Congestion, Cough, Cold and Flu Relief

Product NDC: 51316-463
11-digit product format: 513160463
Labeler code: 51316
Product ID: 51316-463_a9e95a6e-bbd4-4434-a202-75251108c20a
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Triprolidine HCl
Dosage form: KIT
Labeler: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-05-27
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Severe Congestion, Cough, Cold and Flu Relief
Brand name suffix: Maximum Strength, Nighttime
Listing expiration: 2026-12-31

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
2173667	Internal RxNorm lookup
2390630	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
92c570ff-139f-49ff-a7bd-8a540ecc07c7	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
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
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	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
51316-004-45	Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime	177 mL in 1 BOTTLE, PLASTIC	SOLUTION	177 mL	400 mg in 20mL	5
51316-063-45	Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime	177 mL in 1 BOTTLE, PLASTIC	SOLUTION	177 mL	650 mg in 20mL	5
51316-463-99	Severe Congestion, Cough, Cold and Flu ReliefMaximum Strength, Nighttime	1 in 1 PACKAGE	KIT	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-463	SEVERE CONGESTION, COUGH, COLD AND FLU RELIEF MAXIMUM STRENGTH, NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) KIT [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]	4	Current NDC, Legacy NDC, 3 package rows	20241017_92c570ff-139f-49ff-a7bd-8a540ecc07c7.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 149 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antiflu Des Cough and Flu	ACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATE	Productos Farmaceuticos, S.A. de C.V.	dcf3897a-a793-6df7-e053-2995a90a25f8	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FSA STORE INC.	ec6aef90-ece1-4fe6-e053-2995a90a9310	2024-10-16	Warnings	Exact identifier application number: M012
Tukol MAX ACTION Cold, Sore Throat and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Genomma Lab USA, Inc	c8eebe64-00bf-436d-a9fc-1623401bebfa	2024-10-16	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart	4f42c8d2-0538-4bcd-aac0-e26103a30499	2024-10-16	Warnings	Exact identifier application number: M012
Tukol MAX ACTION Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Genomma Lab USA, Inc	9ac3e24a-d18a-48fc-8005-55393085d57b	2024-10-16	Warnings	Exact identifier application number: M012
Nighttime Cough	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	45471fdd-c4cd-46ad-a932-aa37327e8a41	2024-10-16	Warnings	Exact identifier application number: M012
DG Health Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp Inc	8cb15a8d-c836-4167-bc6b-dd20a34076e8	2024-10-16	Warnings	Exact identifier application number: M012
basic care nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	f4497e56-c69d-4ae9-bd81-80bf2ee1b17f	2024-10-15	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	8256c1fb-683d-56ab-e053-2a91aa0ac197	2024-10-15	Warnings	Exact identifier application number: M012
SINUS SEVRE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	9f9586e3-a8b4-4060-e053-2995a90aa068	2024-10-15	Warnings	Exact identifier application number: M012
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	9f95715f-63dc-6086-e053-2a95a90adb0c	2024-10-15	Warnings	Exact identifier application number: M012
Allergy MultiSymptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	a61636e9-8fe2-8419-e053-2a95a90a011c	2024-10-15	Warnings	Exact identifier application number: M012
SINUS AND HEADACHE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	9f95b2e8-dea4-ef59-e053-2a95a90a0bcb	2024-10-15	Warnings	Exact identifier application number: M012
Cold Multi-Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	American Sales Company	d2dcbc7c-e66c-4922-83df-c706a37bf334	2024-10-15	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC. (	9f958d97-8dcf-332d-e053-2995a90a0a65	2024-10-15	Warnings	Exact identifier application number: M012
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Retail Business Services , LLC.	8bc68a71-62c5-a04f-e053-2995a90a92fd	2024-10-15	Warnings	Exact identifier application number: M012
COLD FLU AND SORE THROAT	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	9f960566-0158-6637-e053-2995a90a9c4a	2024-10-15	Warnings	Exact identifier application number: M012
HEAD CONGESTION PLUS FLU SEVERE PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	e65cf21d-3d69-a53e-e053-2a95a90a1c83	2024-10-15	Warnings	Exact identifier application number: M012
night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	H E B	49f5f4d3-556c-4ee3-b5cd-5331dd434bb9	2024-10-15	Warnings	Exact identifier application number: M012
Mielim y mas	DEXTROMETHORPHAN	Efficient Laboratories Inc.	711d1dae-3af4-46af-a3a8-cd827356a81a	2024-10-14	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2390630	{1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack	GPCK	92c570ff-139f-49ff-a7bd-8a540ecc07c7	5
2390630	1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) Pack	PSN	92c570ff-139f-49ff-a7bd-8a540ecc07c7	5
2173667	acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution	PSN	92c570ff-139f-49ff-a7bd-8a540ecc07c7	5
1043543	dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	92c570ff-139f-49ff-a7bd-8a540ecc07c7	5
2173667	acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution	SCD	92c570ff-139f-49ff-a7bd-8a540ecc07c7	5
1043543	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	92c570ff-139f-49ff-a7bd-8a540ecc07c7	5
2390630	1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG per 20 ML Oral Solution) Pack	SY	92c570ff-139f-49ff-a7bd-8a540ecc07c7	5
2173667	acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution	SY	92c570ff-139f-49ff-a7bd-8a540ecc07c7	5
2173667	APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral Solution	SY	92c570ff-139f-49ff-a7bd-8a540ecc07c7	5
1043543	dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution	SY	92c570ff-139f-49ff-a7bd-8a540ecc07c7	5
1043543	dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution	SY	92c570ff-139f-49ff-a7bd-8a540ecc07c7	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51316-004-45	51316000445	177 mL in 1 BOTTLE, PLASTIC	177 ml					Historical
51316-063-45	51316006345	177 mL in 1 BOTTLE, PLASTIC	177 ml					Historical
51316-463-99	51316046399	1 KIT in 1 PACKAGE (51316-463-99) * 177 mL in 1 BOTTLE, PLASTIC (51316-004-45) * 177 mL in 1 BOTTLE, PLASTIC (51316-063-45)	1 kit	2022-05-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS 44-004063	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED \| LNK International, Inc.	2025-10-17	HUMAN OTC DRUG LABEL	5