Daytime Cold and Cough Nighttime Cold and Congestion

Product NDC: 51316-939
11-digit product format: 513160939
Labeler code: 51316
Product ID: 51316-939_1d9b6133-6f2e-4e5c-8c5a-01846d64dbbd
Type: HUMAN OTC DRUG
Nonproprietary name: Brompheniramine Maleate, Dextromethorphan HBr, Diphenhydramine HCl, Phenylephrine HCl
Dosage form: KIT
Labeler: CVS
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-01-31
Marketing end: 2027-01-31
NDC exclude flag: No
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: Daytime Cold and Cough Nighttime Cold and Congestion

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1090463	Internal RxNorm lookup
1236048	Internal RxNorm lookup
1666116	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
2cf361eb-6055-2364-e063-6294a90a69a1	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	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
51316-916-03	Daytime Cold and Cough Nighttime Cold and Congestion	118 mL in 1 BOTTLE	LIQUID	118 mL	1 mg in 5mL	3
51316-916-03	Daytime Cold and Cough Nighttime Cold and Congestion	1 in 1 CARTON	LIQUID		5 mg in 5mL	3
51316-919-03	Daytime Cold and Cough Nighttime Cold and Congestion	118 mL in 1 BOTTLE	LIQUID	118 mL	6.25 mg in 5mL	3
51316-919-03	Daytime Cold and Cough Nighttime Cold and Congestion	1 in 1 CARTON	LIQUID		6.25 mg in 5mL	3
51316-939-04	Daytime Cold and Cough Nighttime Cold and Congestion	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
51316-939	DAYTIME COLD AND COUGH NIGHTTIME COLD AND CONGESTION (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [CVS]	2	Current NDC, 5 package rows	20250206_2cf361eb-6055-2364-e063-6294a90a69a1.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 162 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Cold and Cough Nighttime	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Safeway, Inc.	cbbec807-f882-4c6a-b1cd-c7fd5ce70cad	2024-05-15	Warnings	Exact identifier application number: M012
Cold and Flu Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	d6ac0d70-0511-4ec8-bb35-8b2e0e3d7742	2024-05-15	Warnings	Exact identifier application number: M012
Night Time Cough	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	f658a03b-6fc2-4b63-b3ab-7e886fbf20b4	2024-05-15	Warnings	Exact identifier application number: M012
AXIV DM Max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	VIVUNT PHARMA LLC	18704e66-ee8f-315d-e063-6294a90a5282	2024-05-14	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Target Corporation Inc.	187622dc-ecde-181d-e063-6294a90a4e8f	2024-05-14	Warnings	Exact identifier application number: M012
Lemon Mint Drops	MENTHOL	Target Corporation Inc.	1876df19-398a-23d8-e063-6394a90ae7e8	2024-05-14	Warnings	Exact identifier application number: M012
Cold Flu and Sore Throat Relief Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Safeway, Inc.	6c952c81-c8b6-4e74-abd8-781f6f44736b	2024-05-14	Warnings	Exact identifier application number: M012
Pain and Sinus Reliever	ACETAMINOPHEN AND PHENYLEPHRINE	JHK DBA American Safety & First Aid	249373c6-f56f-4bd3-9cef-98b7ee73457d	2024-05-14	Warnings	Exact identifier application number: M012
Nasal	PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	fea71cb9-e044-4729-ad26-1db0cdb9dd11	2024-05-14	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	a70ead03-6d2c-44c1-9ae5-f6c4094821ec	2024-05-14	Warnings	Exact identifier application number: M012
Day Time Cold and Flu Relief non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Safeway, Inc.	cc450f89-a156-48e0-82ae-19782f13c2ca	2024-05-13	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Safeway, Inc.	a8df5c04-0f92-4013-b3e5-2b45009a7b8d	2024-05-13	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE	Safeway, Inc.	f762600a-f4b1-4869-a04b-8431c3d8a3e3	2024-05-13	Warnings	Exact identifier application number: M012
Cold and Flu DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Safeway, Inc.	ef0cd436-5e81-47a7-92d6-58495283ab28	2024-05-13	Warnings	Exact identifier application number: M012
Tussin Cough Sugar Free	DEXTROMETHORPHAN HBR GUAIFENESIN	P & L Development, LLC	7ed2fe86-3346-4308-a9b6-6a264f879b02	2024-05-09	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	KROGER COMPANY	10106c90-f2f0-508e-e063-6294a90a544b	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	Kroger	1013ce02-7b12-335e-e063-6394a90af3e6	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	Kroger	10b08ea8-693e-eb18-e063-6394a90af548	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	10b0bcff-d3bc-f70c-e063-6394a90a35ed	2024-05-08	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger	10b0e0a0-b878-0a9a-e063-6394a90a20e0	2024-05-08	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1666116	{1 (brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack	GPCK	2cf361eb-6055-2364-e063-6294a90a69a1	3
1666116	1 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) Pack	PSN	2cf361eb-6055-2364-e063-6294a90a69a1	3
1090463	brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	2cf361eb-6055-2364-e063-6294a90a69a1	3
1236048	diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	2cf361eb-6055-2364-e063-6294a90a69a1	3
1090463	brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	2cf361eb-6055-2364-e063-6294a90a69a1	3
1236048	diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	2cf361eb-6055-2364-e063-6294a90a69a1	3
1666116	1 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) Pack	SY	2cf361eb-6055-2364-e063-6294a90a69a1	3
1666116	1 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) Pack	SY	2cf361eb-6055-2364-e063-6294a90a69a1	3
1090463	brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	2cf361eb-6055-2364-e063-6294a90a69a1	3
1090463	brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY	2cf361eb-6055-2364-e063-6294a90a69a1	3
1236048	diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	2cf361eb-6055-2364-e063-6294a90a69a1	3
1236048	diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution	SY	2cf361eb-6055-2364-e063-6294a90a69a1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51316-916-03	51316091603	118 mL in 1 BOTTLE	118 ml					Historical
51316-919-03	51316091903	118 mL in 1 BOTTLE	118 ml					Historical
51316-939-04	51316093904	1 KIT in 1 KIT (51316-939-04) * 1 BOTTLE in 1 CARTON (51316-916-03) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (51316-919-03) / 118 mL in 1 BOTTLE	1 kit	2025-01-31	2027-01-31	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children's Daytime Cold & Cough Nighttime Congestion and Cold	CVS \| Guardian Drug Company	2026-03-16	Human OTC Drug Label	3