FDA.reportPublic FDA data

dg health day time severe cold and flu relief night time severe cold and flu relief

Product NDC
55910-643
11-digit product format
559100643
Labeler code
55910
Product ID
55910-643_6c221739-a47f-459d-b9b1-85a7059ca2ae
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate
Dosage form
KIT
Labeler
Dolgencorp, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-26
NDC exclude flag
No
Listing certified through
2026-12-31
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
dg health day time severe cold and flu relief night time severe cold and flu relief
Listing expiration
2026-12-31

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
f721b393-9ad5-4fc6-a2c5-bd89e58caf16Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-432-00dg health day time severe cold and flu relief night time severe cold and flu relief2 in 1 BLISTER PACKTABLET, FILM COATED165 mg3
55910-643-90dg health day time severe cold and flu relief night time severe cold and flu relief1 in 1 CARTONKIT13
55910-725-00dg health day time severe cold and flu relief night time severe cold and flu relief2 in 1 BLISTER PACKTABLET, FILM COATED86.25 mg3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-643DG HEALTH DAY TIME SEVERE COLD AND FLU RELIEF NIGHT TIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE) KIT [DOLGENCORP, LLC]3Current NDC, Legacy NDC, 3 package rows20241116_f721b393-9ad5-4fc6-a2c5-bd89e58caf16.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 106 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique ChlorphenCHLORPHENIRAMINE MALEATEUnifirst First Aid Corporationb3d5d161-8d4c-f1bb-e053-2a95a90a5bc52025-09-08WarningsExact identifier
application number: M012
Crane Safety Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDECrane Safety LLC968baa85-ce0e-0c3d-e053-2995a90ac03a2025-09-08WarningsExact identifier
application number: M012
Thompson Cherry Cough DropsMENTHOLThompson Safety LLCc948f5b0-8491-6f9f-e053-2995a90a55fa2025-09-08WarningsExact identifier
application number: M012
Medique Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid Corporatione64c283b-0efa-0bfd-e053-2a95a90ab71d2025-09-08WarningsExact identifier
application number: M012
Daytime Nighttime Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATEWalgreensa99fdd49-0160-4a82-983b-fa56ab38ae762025-09-08WarningsExact identifier
application number: M012
Dye Free Wal Dryl Allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEWalgreens53e6f72d-15a4-4efe-8b1f-5753fed53df82025-09-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreens40bfd631-51a4-4684-9ba0-a365d61da9bc2025-09-08WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreensf796ce1f-3077-4a0d-a41a-249c345ddb5f2025-09-08WarningsExact identifier
application number: M012
equate nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWal-Mart Stores Inc6ccbd537-2264-4b3c-804e-3d3ea5368a5f2025-09-05WarningsExact identifier
application number: M012
Ephedrine SulfateEPHEDRINE SULFATEWalgreen Companydc0072f9-7111-1af0-e053-2a95a90aed562025-09-04WarningsExact identifier
application number: M012
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBrACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS Pharmacy, Inc31aa77e0-cfdb-57a8-e063-6394a90af98c2025-09-04WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATECVS Pharmacy, Inc.4bb70a55-de44-3dc1-e054-00144ff8d46c2025-09-04WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATECVS PHARMACYa645b31e-7da7-4fe6-a04f-ac794ef524942025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de637b1-3402-db86-e063-6294a90ac9812025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CMedical Group Care LLCf4a9cfec-0725-8f4a-e053-2995a90a1b4a2025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de65c99-6c2d-3650-e063-6394a90aa98c2025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREEMedical Group Care LLCf4a9d879-4736-4f63-e053-2995a90adeba2025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de66240-441c-00ad-e063-6294a90a4a052025-09-03WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS ASSORTED CITRUS VITAMIN CMedical Group Care LLCff99c57a-e06a-69d3-e053-6394a90a67752025-09-03WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS VITAMIN C SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3de7ace0-e389-b751-e063-6394a90ab4e92025-09-03WarningsExact 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) } PackGPCKf721b393-9ad5-4fc6-a2c5-bd89e58caf163
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) PackPSNf721b393-9ad5-4fc6-a2c5-bd89e58caf163
1546881acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral TabletPSNf721b393-9ad5-4fc6-a2c5-bd89e58caf163
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNf721b393-9ad5-4fc6-a2c5-bd89e58caf163
1546881acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf721b393-9ad5-4fc6-a2c5-bd89e58caf163
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf721b393-9ad5-4fc6-a2c5-bd89e58caf163
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) PackSYf721b393-9ad5-4fc6-a2c5-bd89e58caf163
1546881APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYf721b393-9ad5-4fc6-a2c5-bd89e58caf163
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYf721b393-9ad5-4fc6-a2c5-bd89e58caf163

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-432-00559100432002 in 1 BLISTER PACKHistorical
55910-643-90559100643901 KIT in 1 CARTON (55910-643-90) * 2 TABLET, FILM COATED in 1 BLISTER PACK (55910-432-00) * 2 TABLET, FILM COATED in 1 BLISTER PACK (55910-725-00) 1 kit2021-05-260000-00-00NoNoCurrent
55910-725-00559100725002 in 1 BLISTER PACKHistorical