NyQuil Cold and Flu w/VapoCOOL, 4ct

Product NDC: 85237-1917
11-digit product format: 852371917
Labeler code: 85237
Product ID: 85237-1917_5e1687ef-4d22-558e-e063-6294a90a4bf5
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, doxylamine succinate, dextromethorphan hydrobromide tablet, coated
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Select Consumer Group
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-06-01
Substance: DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 6.25; 325; 10 mg/1; mg/1; mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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: NyQuil Cold and Flu w/VapoCOOL, 4ct
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYLAMINE SUCCINATE	6.25 mg/1
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V9BI9B5YI2	Internal UNII lookup
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2713312	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
5e168528-85d5-55cb-e063-6294a90aec14	Available on FDA.report

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 160 of 174 · 3,464 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Cold and Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	P & L Development, LLC	c08b150c-d821-466c-8521-f77535d6af1e	2024-04-30	Warnings	Exact identifier application number: M012
childrens allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreen Company	7848bb09-2af8-47f6-b32d-96635a750a55	2024-04-29	Warnings	Exact identifier application number: M012
Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Haleon US Holdings LLC	7decc168-e847-4bbe-910b-26081469406f	2024-04-26	Warnings	Exact identifier application number: M012
Severe cold and flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI	P & L Development, LLC	7c92bdcf-db1f-4299-982f-6a3da9cba6e6	2024-04-25	Warnings	Exact identifier application number: M012
Severe cold and flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI	P & L Development, LLC	15727e06-7bfc-424e-9e68-cc9cd5695bfd	2024-04-25	Warnings	Exact identifier application number: M012
Severe Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	P & L Development, LLC	5872fed8-862b-44a2-a06e-51ebf8618271	2024-04-25	Warnings	Exact identifier application number: M012
CHERRY COUGH DROPS 50CT	MENTHOL, UNSPECIFIED FORM	JHK Inc dba American Safety & First Aid	2f54b9c1-3a37-48fd-b964-6aa2631b8e62	2024-04-24	Warnings	Exact identifier application number: M012
Dye Free Allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	QUALITY CHOICE (Chain Drug Marketing Association)	f1a33c2f-2330-43f3-8026-de21808aec66	2024-04-22	Warnings	Exact identifier application number: M012
Cold and Flu Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	fc7954a6-d061-4160-b1d1-a19eb9eabff4	2024-04-22	Warnings	Exact identifier application number: M012
Dibromm Cold and Allergy Childrens	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	ea285d5a-9eb4-4f71-bb1b-4e24a8972819	2024-04-22	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	c573da1e-c7ca-46e6-ad42-4ded2547afc3	2024-04-22	Warnings	Exact identifier application number: M012
Cough Relief Cough Suppressant	DEXTROMETHORPHAN HBR	QUALITY CHOICE (Chain Drug Marketing Association)	13ae4c67-a3fe-440c-91b8-c9412626c3cd	2024-04-22	Warnings	Exact identifier application number: M012
Pain Relief PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	47660794-22cc-4863-a183-e694d27e3543	2024-04-19	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	f9c08b18-a119-406b-bd96-73572b4445e2	2024-04-18	Warnings	Exact identifier application number: M012
Nighttime Cough Relief	DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	e1fa0f51-6a68-4f6f-8988-0949d1942c2f	2024-04-18	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	025f6622-a6db-4a5c-aebd-5d54172fa4a1	2024-04-18	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	f9530d55-8226-4659-84f0-2c0b411572be	2024-04-17	Warnings	Exact identifier application number: M012
MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME	ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 10 MG PHENYLEPHRINE HCI 5 MG	RITE AID	c92dbbbb-d149-1e7e-e053-2a95a90a6f1a	2024-04-17	Warnings	Exact identifier application number: M012
MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIME	ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 15 MG DOXYLAMINE SUCCINATE 6.25 MG	RITE AID	c9323799-3505-d6c1-e053-2995a90a6f43	2024-04-17	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	fac8b01a-9666-43cc-a4ff-3f3ed452c7e4	2024-04-17	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85237-1917-1	85237191701	1 POUCH in 1 CARTON (85237-1917-1) / 2 TABLET, COATED in 1 POUCH (85237-1917-0)	1 pouch	2025-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NyQuil ™ Cold & Flu w/VapoCOOL, 4ct (PE-free)	Select Consumer Group \| Selecet Consumer Group	2026-10-17	HUMAN OTC DRUG LABEL	1