daytime cold and flu nighttime cold and flu

Product NDC
79481-5200
11-digit product format
794815200
Labeler code
79481
Product ID
79481-5200_f857f8f6-75d6-464c-b305-48df7387e875
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate
Dosage form
KIT
Labeler
Meijer, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-21
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct79481-5200UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage79481-520079481-5200-0UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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 cold and flu nighttime cold and flu
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1110988Internal RxNorm lookup
1546881Internal RxNorm lookup
2634817Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df31056b-d0eb-4094-98d9-3d444210d50dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-569-00daytime cold and flu nighttime cold and flu2 in 1 BLISTER PACKTABLET, FILM COATED325 mg4
79481-0099-0daytime cold and flu nighttime cold and flu2 in 1 BLISTER PACKTABLET, FILM COATED166.25 mg4
79481-5200-0daytime cold and flu nighttime cold and flu1 in 1 CARTONKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-5200DAYTIME COLD AND FLU NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE) KIT [MEIJER, INC.]4Current NDC, Legacy NDC, 3 package rows20250120_df31056b-d0eb-4094-98d9-3d444210d50d.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 175 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multi-Symptom Mapap Cold FormulaACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLProficient Rx LP9bf81b26-38b4-486c-ae89-222119ce1a4f2023-11-01WarningsExact identifier
application number: M012
Guaifenesin Syrup and DextromethorphanGUAIFENESIN SYRUP AND DEXTROMETHORPHANNatco Pharma USA LLCad9026f4-f0b6-4d02-aa44-f0460eeefc0e2023-11-01WarningsExact identifier
application number: M012
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HYDROCHLORIDENatco Pharma USA LLC54b64354-ac10-42ff-a53d-96cef933a91a2023-11-01WarningsExact identifier
application number: M012
children allergy relief dye free cherryDIPHENHYDRAMINE HCLA-S Medication Solutions5c6c1809-4c6f-4e8f-a5ae-9796e821d4002023-11-01WarningsExact identifier
application number: M012
Daytime and Nighttime Cherry Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION0903b222-1a44-64aa-e063-6294a90abba02023-10-31WarningsExact identifier
application number: M012
Ephrine Nose DropsPHENYLEPHRINE HYDROCHLORIDEWalgreensb620eb9f-2caf-0942-e053-2a95a90ae48e2023-10-31WarningsExact identifier
application number: M012
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLA-S Medication Solutions204849d1-ac4b-4dbe-8769-fcb30291f8802023-10-31WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefDAYTIME COLD AND FLU RELIEFTopCo Associates, LLCd592fbb8-d4bf-444e-982e-edf6fe97dce42023-10-31WarningsExact identifier
application number: M012
Nite Time Cold and Flu ReliefNITE TIME COLD AND FLU RELIEFTopCo Associates, LLC407dc4ae-882d-4a49-8884-ef048bb404cf2023-10-31WarningsExact identifier
application number: M012
12 Hour Original Nasal DecongestantNASAL SPRAYSheffield Pharmaceuticals LLCcea0ce76-ae75-4484-a7c2-ff1086e9d8b02023-10-30WarningsExact identifier
application number: M012
Mucosa DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMagno-Humphries, Inc.3a5533fb-1c83-4b95-9cd2-9be663d3ff5f2023-10-27WarningsExact identifier
application number: M012
Mucosa GuifenesinGUAIFENESINMagno-Humphries, Inc.9d22c208-d0ae-8b6a-e053-2995a90ab90a2023-10-27WarningsExact identifier
application number: M012
DG Health Cough Drops Cherry FlavorMENTHOLDollar General Corporationc7a603d8-72fb-9626-e053-2995a90a09ea2023-10-26WarningsExact identifier
application number: M012
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEGeri-Care Pharmaceutical Corp92d90b41-0627-121e-e053-2995a90a2df12023-10-26WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol CherryMENTHOLRiclan S.A.8e471265-3594-451a-8921-f0db474abe852023-10-26WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol EucalyptusMENTHOLRiclan S.A.1141593a-f3ba-4adf-b332-f9fcb0b5a0132023-10-26WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey LemonMENTHOLRiclan S.A.f6271e85-9ca2-41d3-9bff-a13670ac5b802023-10-26WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol StrawberryMENTHOLRiclan S.A.da2bbc92-7d96-4f3e-89e2-c2a9e3e4b4572023-10-26WarningsExact identifier
application number: M012
DG Health Cough Drops Assorted FlavorsMENTHOLDollar General Corporationc731d255-40f2-3cb3-e053-2a95a90a88772023-10-26WarningsExact identifier
application number: M012
ALKA SELTZER PLUS Cold Day and Night EffervescentASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATESincronia Logistica, S.A. de C.V.c478df69-823a-4112-8f44-323249a9f38f2023-10-23WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634817{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } PackGPCKdf31056b-d0eb-4094-98d9-3d444210d50d4
26348171 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet) PackPSNdf31056b-d0eb-4094-98d9-3d444210d50d4
1546881acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral TabletPSNdf31056b-d0eb-4094-98d9-3d444210d50d4
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNdf31056b-d0eb-4094-98d9-3d444210d50d4
1546881acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDdf31056b-d0eb-4094-98d9-3d444210d50d4
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDdf31056b-d0eb-4094-98d9-3d444210d50d4
26348171 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet) PackSYdf31056b-d0eb-4094-98d9-3d444210d50d4
1546881APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYdf31056b-d0eb-4094-98d9-3d444210d50d4
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYdf31056b-d0eb-4094-98d9-3d444210d50d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-569-00412500569002 in 1 BLISTER PACKHistorical
79481-0099-0794810099002 in 1 BLISTER PACKHistorical
79481-5200-0794815200001 KIT in 1 CARTON (79481-5200-0) * 2 TABLET, FILM COATED in 1 BLISTER PACK (41250-569-00) * 2 TABLET, FILM COATED in 1 BLISTER PACK (79481-0099-0) 1 kit2021-08-210000-00-00NoNoCurrent