Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu

Product NDC
69842-462
11-digit product format
698420462
Labeler code
69842
Product ID
69842-462_b417d1de-3020-4a0b-8589-a4612acd9957
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form
KIT
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-04-30
Marketing end
2027-01-30
NDC exclude flag
No
Current FDA listing
Yes

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69842-462-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69842-462-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69842-462-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69842-462-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69842-462-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69842-462-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69842-462-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69842-462-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69842-462-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69842-462-12557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69842-462-128af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69842-462-12834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69842-462-121332a3947898…d4bfe170f9cd…

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
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu
Brand name suffix
Maximum Strength

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043543Internal RxNorm lookup
1375932Internal RxNorm lookup
2637728Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
91c803c8-6cf8-4ff6-b376-ea6d65f9f227Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-462-122025-07-01C16284748780-1f386c64a-3a8d-0266-e053-dadaa90a7c1aDrug Facts
69842-462-122023-01-30C16284748780-1f386c64a-3a8d-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-462-12Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and FluMaximum Strength1 in 1 KITKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-462DAYTIME MUCUS RELIEF SEVERE CONGESTION AND COUGH AND NIGHTTIME COLD AND FLU MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]2Current NDC, Legacy NDC, 1 package rows20191101_91c803c8-6cf8-4ff6-b376-ea6d65f9f227.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 50 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDELEADER/ Cardinal Health 110, Inc.e33cbd1d-1848-145a-e053-2995a90aeb502026-02-20WarningsExact identifier
application number: M012
Head Congestion and Flu Severe ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation416080a9-e817-485b-a4ae-6c9d0152c1652026-02-20WarningsExact identifier
application number: M012
Walmart Dye Free Chidrens Allergy ChewsDIPHENHYDRAMINE HCLWALMART STORES INC18436026-b0e4-4481-a647-d735a27d0b002026-02-19WarningsExact identifier
application number: M012
VaporizingCAMPHORMeijer, Inc.7afc98d7-f64f-42d5-9022-28ad6b01db8a2026-02-19Warnings, Adverse reactionsExact identifier
application number: M012
CHILDRENS COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEKroger Company8196b482-070e-4d7d-8943-129141f926ee2026-02-19WarningsExact identifier
application number: M012
Walmart Dye Free Chidrens Allergy Chews BubblegumDIPHENHYDRAMINE HCLWALMART STORES INC9f83d2f0-9718-4f2b-bc7f-e29ba29174122026-02-19WarningsExact identifier
application number: M012
tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINKroger Companybe9aaf66-6c59-4042-88e2-acd920dcf9922026-02-19WarningsExact identifier
application number: M012
Allergy Relief Dye-FreeDIPHENHYDRAMINE HCLCVS Pharmacy08459cf4-feb3-4283-88e1-d61e030c57f92026-02-19WarningsExact identifier
application number: M012
allergy reliefCHLORPHENIRAMINE MALEATERite Aid Corporationb0d70488-ea1d-4c1d-bd07-53dfb0e4d03c2026-02-18WarningsExact identifier
application number: M012
Walgreens Wild Cherry Pectin Throat DropsPECTINWalgreens424fda2d-c1e5-0ed9-e063-6394a90a06ea2026-02-18WarningsExact identifier
application number: M012
cough suppressant and topical analgesicCAMPHOR, EUCALYPTUS OIL, MENTHOLTarget Corporationdf21d9d6-36a9-49cf-a29c-c4a573899bd52026-02-18Warnings, Adverse reactionsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEAmerisource Bergeneeda80ff-212d-428e-a0c6-782f271357b42026-02-18WarningsExact identifier
application number: M012
good sense night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL. Perrigo Companye47dffdf-5778-4804-8ce2-54c5a72bba3a2026-02-18WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLUnited Natural Foods, Inc. dba UNFIb139e7d6-bf4d-45b9-b7cf-d34e5352095c2026-02-17Warnings, Adverse reactionsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLStrategic Sourcing Services LLCbd54bf7a-2304-4c3f-9cd2-bafea217466e2026-02-17Warnings, Adverse reactionsExact identifier
application number: M012
Creomulsion For ChildrenDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d0e96c-1cc3-4961-e054-00144ff88e882026-02-17WarningsExact identifier
application number: M012
Creomulsion Cough Medicine Adult FormulaDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d07486-99b7-5c06-e054-00144ff8d46c2026-02-17WarningsExact identifier
application number: M012
Cold and Flu Severe, Day, NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR. GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.6e6bae79-1231-4b74-81c1-f0c914ed4af32026-02-17WarningsExact identifier
application number: M012
COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdfe69c12-b5fe-46d1-a3bf-ef3729c2e7862026-02-17WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED3fb49f64-2d77-44db-8186-5904837eedbe2026-02-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637728{1 (acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } PackGPCK91c803c8-6cf8-4ff6-b376-ea6d65f9f2273
26377281 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution) PackPSN91c803c8-6cf8-4ff6-b376-ea6d65f9f2273
1375932acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN91c803c8-6cf8-4ff6-b376-ea6d65f9f2273
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN91c803c8-6cf8-4ff6-b376-ea6d65f9f2273
1375932acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD91c803c8-6cf8-4ff6-b376-ea6d65f9f2273
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD91c803c8-6cf8-4ff6-b376-ea6d65f9f2273
26377281 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) PackSY91c803c8-6cf8-4ff6-b376-ea6d65f9f2273
1375932acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY91c803c8-6cf8-4ff6-b376-ea6d65f9f2273
1375932acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY91c803c8-6cf8-4ff6-b376-ea6d65f9f2273
1375932APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY91c803c8-6cf8-4ff6-b376-ea6d65f9f2273
1375932APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY91c803c8-6cf8-4ff6-b376-ea6d65f9f2273
1375932APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSY91c803c8-6cf8-4ff6-b376-ea6d65f9f2273
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY91c803c8-6cf8-4ff6-b376-ea6d65f9f2273
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY91c803c8-6cf8-4ff6-b376-ea6d65f9f2273

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-462-12698420462121 KIT in 1 KIT (69842-462-12) * 177 mL in 1 BOTTLE, PLASTIC * 177 mL in 1 BOTTLE, PLASTIC1 kit2018-04-302027-01-30NoNoCurrent