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 177 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief Immediate Release	GUAIFENESIN 400MG	TopCo Associates, LLC	7d91c6ab-d161-42b9-b353-0aa8f59619f8	2021-01-21	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MG	Allegiant Health	bed5f9dc-45ea-4e90-86c6-86599b6f3861	2020-11-16	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN	Allegiant Health	b97126d7-847d-483e-b3d1-e2b61ab1743f	2020-11-11	Warnings	Exact identifier application number: M012
Cold and Allergy	PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE	Allegiant Health	7af63769-fa56-4f1f-a2ad-5b4c108c8e4f	2019-12-12	Warnings	Exact identifier application number: M012
Mucus Relief Immediate Release	GUAIFENESIN	Allegiant Health	221d64a2-b8c7-435a-aae4-fb58fd38108f	2019-03-26	Warnings	Exact identifier application number: M012
Sleep Tabs For Nighttime use	DIPHENHYDRAMINE HCL TABLETS	Allegiant Health	566e40b1-e9d7-44e4-b971-eef2b7cf0a7d	2018-12-26	Warnings	Exact identifier application number: M012
Allergy	CHLORPHENIRAMINE MALEATE	Allegiant Health	4305ad50-d2a5-4d3e-9d92-cbf26e856a16	2018-12-26	Warnings	Exact identifier application number: M012
Sleep Aid	DIPHENHYDRAMINE HCL 25 MG	Allegiant Health	dbbc535f-515a-4d9b-b799-34e60f5230bb	2018-12-21	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL	Allegiant Health	c2823bad-540f-4662-8dcc-58e9f0d94efb	2018-11-07	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength Non-Drowsy	PHENYLEPHRINE 10 MG	Allegiant Health	7aef00df-816a-4ea2-a2ad-beed66dd2fe4	2018-11-07	Warnings	Exact identifier application number: M012
DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	a58bfb14-28f9-4425-a5a5-aaff4847c979	2018-03-14	Warnings	Exact identifier application number: M012
Chlorpheniramine maleate 4mg	CHLORPHENIRAMINE MALEATE 4MG	Athlete's Needs, Inc.	4d974959-25fc-4707-9b72-9afbf47b76f1	2017-11-14	Warnings	Exact identifier application number: M012
Cold Medicine	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Selder, S.A. de C.V.	d2762d9c-e7e7-42b2-a26a-14b2aa0307cb	2017-01-25	Warnings	Exact identifier application number: M012
Allergy	CHLORPHENIRAMINE MALEATE	Marc Glassman, Inc.	2051247f-ce64-4cf5-b449-9ca14c43ab86	2016-12-27	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