Nighttime Cold and Flu Relief

Product NDC: 83324-164
11-digit product format: 833240164
Labeler code: 83324
Product ID: 83324-164_1126fad8-8854-417b-8dad-4c2874f6b208
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen Dextromethorphan HBr Doxylamine Succinate
Dosage form: LIQUID
Route: ORAL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-07-31
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
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: Nighttime Cold and Flu Relief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/30mL
DOXYLAMINE SUCCINATE	12.5 mg/30mL

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
9D2RTI9KYH	Internal UNII lookup
V9BI9B5YI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1043400	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
f9530d55-8226-4659-84f0-2c0b411572be	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83324-164-08	Nighttime Cold and Flu Relief	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83324-164	NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1	Current NDC, 1 package rows	20240731_f9530d55-8226-4659-84f0-2c0b411572be.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 84 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quality Choice Mucus Relief	GUAIFENESIN	Chain Drug Marketing Association	f1a73da7-0dbb-49bd-857e-7dd6bc11b63c	2025-12-02	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	ac74be47-30f0-418b-bd07-502feaa9723f	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens High Blood Pressure Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN	WALGREENS CO.	bc83b55e-c3d8-460f-8ef9-ff7b2e4f7272	2025-12-01	Warnings	Exact identifier application number: M012
Walgreen High Blood Pressure Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREENS CO.	f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Nighttime Kids Honey Cold Cough Congestion	DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO	c0f317cd-723d-47f2-b600-aaeae6399482	2025-12-01	Warnings	Exact identifier application number: M012
Walgreen Maximum Strength Severe Congestion and cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALGREENS CO.	b4abcb6d-f3e1-4d63-98cf-ff556ec423b6	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Daytime Childrens	COUGH AND CHEST CONGESTION	WALGREENS CO.	dd99675f-3860-42ef-999c-d9a3746a38c0	2025-12-01	Warnings	Exact identifier application number: M012
Adult Cough plus Chest Congestion DM with Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN	WALGREEN COMPANY	5f5af13a-c2a3-4bbe-880e-9c57b36e9234	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WALGREEN COMPANY	b2e08f4d-9753-4767-a8eb-3740dd1034cc	2025-12-01	Warnings	Exact identifier application number: M012
WALGREENS Cold Cough and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO.	1e903034-942e-4c6e-9f96-eb097c266580	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens DAY and NIGHT PACK	DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	WALGREEN CO	cb87e57b-ff06-4973-9751-137c7021e272	2025-12-01	Warnings	Exact identifier application number: M012
WALGREEN Multi Symptom Flu Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	WALGREENS CO.	b7b1d604-921d-4ae7-93de-dcf690d421b4	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Meijer Distribution Inc	235b2866-bbda-7148-e063-6394a90a898f	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Whole Foods Market, INC.	32352109-31dc-8e6f-e063-6294a90a2f92	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	323347c3-d51a-4976-e063-6294a90a952e	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	WALGREEN COMPANY	2969ba8f-c477-222a-e063-6394a90af703	2025-12-01	Warnings	Exact identifier application number: M012
CareAll Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS	New World Imports, Inc	4cd2f751-e072-4f4e-b059-ed1dfcc60c6b	2025-12-01	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS PHARMACY, INC	bbb1b395-48d9-4859-ad52-6650961089d9	2025-12-01	Warnings	Exact identifier application number: M012
Severe Sinus Pain and Congestion	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	fbc541ac-9465-4296-bb1e-811b9d811f40	2025-11-26	Warnings	Exact identifier application number: M012
Daytime Severe and Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Grocery Outlet, Inc.	447951e6-459d-0a52-e063-6294a90a6226	2025-11-26	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
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution	PSN	f9530d55-8226-4659-84f0-2c0b411572be	1
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	f9530d55-8226-4659-84f0-2c0b411572be	1
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	f9530d55-8226-4659-84f0-2c0b411572be	1
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	f9530d55-8226-4659-84f0-2c0b411572be	1
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	f9530d55-8226-4659-84f0-2c0b411572be	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83324-164-08	83324016408	237 mL in 1 BOTTLE, PLASTIC (83324-164-08)	237 ml	2024-07-31	No	No	Current