Vicks DayQuil Severe

Product NDC
69423-967
11-digit product format
694230967
Labeler code
69423
Product ID
69423-967_eed9f977-14c3-70bb-e053-2a95a90a1ecf
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-07-07
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/15mL; mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69423-967DDiscontinued by firm2026-10-21
excluded packagepackage69423-96769423-967-12DDiscontinued by firm2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 20 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69423-967-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69423-967-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69423-967-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69423-967-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69423-967-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69423-967-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69423-967-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69423-967-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69423-967-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69423-967-12ad56d346431e…cc804d4bbf1e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 148 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLD MAXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTa1aba467-c91f-4812-b0b9-ff5fdfa298e32024-10-17WarningsExact identifier
application number: M012
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTe3dd12f1-dd63-27ae-e053-2995a90aaaeb2024-10-17WarningsExact identifier
application number: M012
COLD and FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTe44ac549-3e9b-4271-a2b2-ecb124f798322024-10-17WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTf171a389-8b22-429c-86bc-272156fdc1b72024-10-17WarningsExact identifier
application number: M012
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MART6c5b5427-e47a-4eff-928a-c891452facf92024-10-17WarningsExact identifier
application number: M012
COLD AND FLU SEVEREACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTddeb8978-84b6-4a19-b25e-99d1c29e58d92024-10-17WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All in OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTb20baef9-6e68-6679-e053-2a95a90a2b632024-10-17WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTb20b71fb-8787-c871-e053-2a95a90a8eb42024-10-17WarningsExact identifier
application number: M012
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDISCOUNT DRUG MARTb20bc492-fed3-bf05-e053-2a95a90ad3932024-10-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIa4d6ecb9-ea67-41ed-917b-9bb4d1e505512024-10-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI08fda81a-bedd-4ff3-9c32-2066d2cea3f92024-10-17WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINAmerican Health Packaging2fd702ea-3069-472c-b99e-c527f13757052024-10-17WarningsExact identifier
application number: M012
Mucus Relief XpectGUAIFENSIN, DEXTROMETHORPHANSelder, S.A. de C.V.c2b49d10-b60f-3072-e053-2a95a90af0042024-10-17WarningsExact identifier
application number: M012
Head Congestion plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI1db914d3-8bba-405e-9bf9-9b1a5806284c2024-10-17WarningsExact identifier
application number: M012
Cold Medicine XL3ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.e2c35fae-9dd6-51f2-e053-2995a90a1e9e2024-10-17WarningsExact identifier
application number: M012
Cough and Cold XL3 XtraACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.da5b31dd-becd-471a-9392-d0ee4b8f95392024-10-17WarningsExact identifier
application number: M012
Cold Medicine XL3 FORTEACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDEMIDWAY IMPORTING INC.58252f15-485c-3061-e053-2a91aa0a23202024-10-17WarningsExact identifier
application number: M012
Cold Medicine XL3ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDEMidway Importing, Inc.e41b9beb-e274-5c02-e053-2995a90ad0f82024-10-17WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC38e70a28-eff2-4a48-b829-8cd68e80beef2024-10-17WarningsExact identifier
application number: M012
Mucus Relief XpectGUAIFENSIN, DEXTROMETHORPHANMidway Importing Inc.c2c8bd26-bbf1-c2e6-e053-2995a90a86a72024-10-17WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-967-0869423096708236 mL in 1 BOTTLE, PLASTIC (69423-967-08) 236 ml2021-07-070000-00-00NoNoCurrent
69423-967-1269423096712354 mL in 1 BOTTLE, PLASTIC (69423-967-12) 354 ml2021-07-070000-00-00NoNoCurrent