Cold Flu Severe Day Night

Product NDC: 37808-286
11-digit product format: 378080286
Labeler code: 37808
Product ID: 37808-286_2501f7ec-b5af-cf9e-e063-6394a90a14c7
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form: KIT
Labeler: HEB
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-03-01
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: Cold Flu Severe Day Night
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
1086991	Internal RxNorm lookup
1110988	Internal RxNorm lookup
2634819	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
ee1477ed-00c4-46ea-bc57-aef214076dc2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37808-286-01	Cold Flu Severe Day Night	1 in 1 CARTON	KIT	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-286	COLD FLU SEVERE DAY NIGHT (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [HEB]	4	Current NDC, Legacy NDC, 1 package rows	20241208_ee1477ed-00c4-46ea-bc57-aef214076dc2.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 89 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	1affbef6-dd27-40c2-a5d3-b121aa62496a	2025-11-15	Warnings	Exact identifier application number: M012
Cold and Flu Day, Night	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	b9adfb5d-6576-4ff8-a7d7-a89b867c5292	2025-11-14	Warnings	Exact identifier application number: M012
PECGEN DMX	DEXTROMETHORPHAN HBR, GUAIFENESIN	KRAMER NOVIS	a627824c-5e3d-4672-a047-6c801b50b432	2025-11-14	Warnings	Exact identifier application number: M012
Supress DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	KRAMER NOVIS	7da0611e-729c-4cf8-88f3-f8877b9f5cfa	2025-11-14	Warnings	Exact identifier application number: M012
G-ZYNCOF	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Kramer Novis	c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc	2025-11-14	Warnings	Exact identifier application number: M012
Tussi Pres B	DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	d0afa44c-3acf-42a5-9889-4e9c10225256	2025-11-14	Warnings	Exact identifier application number: M012
equate vapor ice cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	b2c0692c-ed0b-4fcf-b88d-59a788b124c6	2025-11-14	Warnings	Exact identifier application number: M012
Guaifenesin 400mg	GUAIFENESIN	Marlex Pharmaceuticals Inc	13f4db4e-687e-9d7b-e063-6294a90ab088	2025-11-13	Warnings	Exact identifier application number: M012
Guaifenesin 200mg	GUAIFENESIN	Marlex Pharmaceuticals Inc	13b8f480-d1ac-d70c-e063-6394a90ab4f4	2025-11-13	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	PD-Rx Pharmaceuticals, Inc.	c1873a4c-661f-4896-bcc0-f6d3a655de94	2025-11-13	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	c24b9489-208c-472b-8ae5-c6e86c12e04d	2025-11-13	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Chest Congestion Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	8c821671-dc68-4e27-aa87-b4e45ade9817	2025-11-13	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Severe Cough Plus Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	6a6f5da8-6433-4284-8df7-2d5b099b74dc	2025-11-13	Warnings	Exact identifier application number: M012
equaline allergy	DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	8e4eb1eb-5b55-4531-94d2-998425ec80ed	2025-11-13	Warnings	Exact identifier application number: M012
Cold and Flu DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Safeway, Inc.	7a78f24b-7c23-4318-99dc-90c05db185b1	2025-11-13	Warnings	Exact identifier application number: M012
ZYNCOF	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Kramer Novis	cffd6d5f-0cb2-4d38-bdb0-6a21120418cc	2025-11-13	Warnings	Exact identifier application number: M012
equate vapor ice cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	b6da1659-8c79-4cce-a817-907a7f061a2d	2025-11-13	Warnings	Exact identifier application number: M012
Tussi Pres	GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Kramer Novis	0d4ee530-2a5c-41a0-88bf-ac92d538661b	2025-11-12	Warnings	Exact identifier application number: M012
4 Way Fast Acting	PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	a8fc41c7-4425-41b8-b1c6-eb22ac054734	2025-11-12	Warnings	Exact identifier application number: M012
Quality Choice Vapor Steam	CAMPHOR (SYNTHETIC)	Chain Drug Marketing Association, Inc.	1f1e6be5-d407-330c-e063-6294a90a4e80	2025-11-12	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2634819	{1 (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } Pack	GPCK	ee1477ed-00c4-46ea-bc57-aef214076dc2	4
2634819	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 Oral Tablet) Pack	PSN	ee1477ed-00c4-46ea-bc57-aef214076dc2	4
1086991	acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	ee1477ed-00c4-46ea-bc57-aef214076dc2	4
1110988	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	ee1477ed-00c4-46ea-bc57-aef214076dc2	4
1086991	acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	ee1477ed-00c4-46ea-bc57-aef214076dc2	4
1110988	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	ee1477ed-00c4-46ea-bc57-aef214076dc2	4
2634819	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 Oral Tablet) Pack	SY	ee1477ed-00c4-46ea-bc57-aef214076dc2	4
1086991	APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	ee1477ed-00c4-46ea-bc57-aef214076dc2	4
1110988	APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	ee1477ed-00c4-46ea-bc57-aef214076dc2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-286-01	37808028601	1 KIT in 1 CARTON (37808-286-01) * 8 TABLET, COATED in 1 BLISTER PACK * 8 TABLET, COATED in 1 BLISTER PACK	1 kit	2018-03-01	0000-00-00	No	No	Current