Cold and Flu

Product NDC: 79903-119
11-digit product format: 799030119
Labeler code: 79903
Product ID: 79903-119_79464b22-4b8f-4b4a-8515-27cf47305fdd
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Triprolidine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: WALMART INC.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-05-03
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength: 650; 20; 2.5 mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes: 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: Cold and Flu
Brand name suffix: Nighttime
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/20mL
TRIPROLIDINE HYDROCHLORIDE	2.5 mg/20mL

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
YAN7R5L890	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2173667	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
adb658c8-db8d-4db6-80c8-e0f2de88a2de	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79903-119-45	Cold and FluNighttime	177 mL in 1 BOTTLE, PLASTIC	SOLUTION	177		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79903-119	SEVERE CONGESTION AND COUGH, COLD AND FLU DAYTIME, NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) KIT [WALMART INC.]	6	Current NDC, Legacy NDC	20250430_a53ca6e5-f2cd-46fe-8b7c-87bfef48ac19.zip
79903-119	COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL) SOLUTION [WALMART INC.]	5	Current NDC, Legacy NDC, 1 package rows	20241211_adb658c8-db8d-4db6-80c8-e0f2de88a2de.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 31 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUCINEX Rapid Clear Day Night and Clear and Cool Nasal	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	37dcb0ed-df56-1bec-e063-6394a90a695e	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool	OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN	Reckitt Benckiser LLC	373e0d75-8def-4b98-e063-6394a90a5e47	2026-05-13	Warnings	Exact identifier application number: M012
MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASAL	OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	5a397466-8721-4060-a178-5ebfd7069cc9	2026-05-13	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	350764de-7801-b24e-e063-6394a90ab3c3	2026-05-13	Warnings	Exact identifier application number: M012
Cepacol Extra Strength Sore Throat and Cough	BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	c0cc32db-90f0-4106-8538-89821083ece1	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Cold and Flu	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	e8bc4131-f7b0-926a-e053-2995a90a40ac	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Cold, Flu, and Sore Throat	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	37ded76a-ee8d-f22c-e063-6394a90a00c2	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Night Time Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	fdb5c937-c148-eb46-e053-6394a90a8bed	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Cough Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Reckitt Benckiser LLC	e9c32d81-cd9b-4ff2-e053-2995a90aa499	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	316b5569-b66f-f30c-e063-6394a90ae147	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	d9467ca2-df75-4fa1-92b3-d2101eb54a77	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	12420092-3ef6-464b-9106-2d56cd6ef200	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Sinus Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	09fdf96f-345f-43f2-9f0f-8303ac70849e	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Night Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	2ce31244-9c6c-b7dd-e063-6394a90a31a8	2026-05-13	Warnings	Exact identifier application number: M012
equate daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	2ac53cc7-000f-41fd-b799-4e6d6886fe62	2026-05-13	Warnings	Exact identifier application number: M012
nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Publix Super Markets Inc	2201d5c0-bd51-47a7-9775-916b18573623	2026-05-13	Warnings	Exact identifier application number: M012
topcare nite time cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Topco Associates LLC	f868e4a0-e9fb-4e6a-9984-29a218246241	2026-05-13	Warnings	Exact identifier application number: M012
nitetime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Meijer Distribution Inc	582fa36b-6d0c-4ff3-80ab-6e0da4b209e4	2026-05-13	Warnings	Exact identifier application number: M012
SudoGest	PSEUDOEPHEDRINE HYDROCHLORIDE	Major Pharmaceuticals	78faa497-6743-b85b-e053-2a91aa0ae822	2026-05-12	Warnings	Exact identifier application number: M012
Allergy Relief mini Softgels	DIPHENHYDRAMINE HCI 25 MG	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	df1c620b-ff59-4126-99a5-1d6750888f2b	2026-05-12	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
YAN7R5L890	TRIPROLIDINE HYDROCHLORIDE	6138-79-0	TRIPROLIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2173667	acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution	PSN	adb658c8-db8d-4db6-80c8-e0f2de88a2de	7
2173667	acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution	SCD	adb658c8-db8d-4db6-80c8-e0f2de88a2de	7
2173667	acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution	SY	adb658c8-db8d-4db6-80c8-e0f2de88a2de	7
2173667	APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral Solution	SY	adb658c8-db8d-4db6-80c8-e0f2de88a2de	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79903-119-45	79903011945	177 mL in 1 BOTTLE, PLASTIC (79903-119-45)	177 ml	2022-05-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Equate 44-063	WALMART INC. \| LNK International, Inc.	2026-05-27	HUMAN OTC DRUG LABEL	7
Equate 44-004063-Delisted	WALMART INC. \| LNK International, Inc.	2025-04-29	HUMAN OTC DRUG LABEL	6