basic care daytime cold and flu nighttime cold and flu

Product NDC
72288-580
11-digit product format
722880580
Labeler code
72288
Product ID
72288-580_3fea38da-3f5f-42b3-b1ef-372ac34ba133
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
Dosage form
KIT
Labeler
Amazon.com Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-26
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
basic care 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
1086997Internal RxNorm lookup
1094549Internal RxNorm lookup
2634564Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ceb342da-ff6d-4c19-9f78-0033d028075eAvailable 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
72288-056-00basic care daytime cold and flu nighttime cold and flu8 in 1 CARTONCAPSULE, LIQUID FILLED6.25 mg3
72288-056-00basic care daytime cold and flu nighttime cold and flu2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED166.25 mg3
72288-580-72basic care daytime cold and flu nighttime cold and flu1 in 1 CARTONKIT13
72288-994-00basic care daytime cold and flu nighttime cold and flu16 in 1 CARTONCAPSULE, LIQUID FILLED5 mg3
72288-994-00basic care daytime cold and flu nighttime cold and flu2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED3210 mg3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-580BASIC CARE DAYTIME COLD AND FLU NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [AMAZON.COM SERVICES LLC]3Current NDC, Legacy NDC, 5 package rows20241116_ceb342da-ff6d-4c19-9f78-0033d028075e.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 87 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GANMAOLINGACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.c757a03e-59ea-469c-970d-4bc62e73f36f2025-11-18WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepacke1d545dc-9222-4d61-964d-1c781215d7d22025-11-18WarningsExact identifier
application number: M012
Goodnow cold flu day relief cold flu night reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLGobrands, Inc7590d0c6-121e-4016-b6bb-534c5d0a79702025-11-17WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast FizzCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDER J General Corporationd786ae07-ce57-44c7-9ba5-f4c87df115de2025-11-17WarningsExact identifier
application number: M012
Benadryl AllergyDIPHENHYDRAMINE HYDROCHLORIDER J General Corporationc46c01c0-29f4-400c-bef5-14b3eb944c512025-11-17WarningsExact identifier
application number: M012
TYLENOL COLD AND FLUACETAMINPHENR J General Corporationb618877b-9dbc-4ba2-be2c-bf1922c646cc2025-11-17WarningsExact identifier
application number: M012
TYLENOL SINUS SEVEREACETAMINOPHENR J General Corporation2cbf7954-b28f-4d7b-b142-6c6c5c58b25d2025-11-17WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRR J General Corporation8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc2025-11-17WarningsExact identifier
application number: M012
Quality Choice Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILQUALITY CHOICE (Chain Drug Marketing Association)c0e3c959-bed6-2ce5-e053-2995a90a0be92025-11-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corpc5ea5a7a-c806-e5e0-e053-2995a90a15e92025-11-17WarningsExact identifier
application number: M012
Multi-Symptom Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED50f3157b-5788-4b63-835a-e60c8dc33df92025-11-17WarningsExact identifier
application number: M012
Day and Night SinusACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores Inca9d809f5-63a1-4f80-8b4d-33e8e052c7bd2025-11-15WarningsExact identifier
application number: M012
Cold and Flu Day, NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company937b481a-e0b7-4d34-a8a1-0bfb2b867c2b2025-11-15WarningsExact identifier
application number: M012
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.f701a6ae-200d-48dc-94e4-6bd3228f50d42025-11-15WarningsExact identifier
application number: M012
MULTI-SYMPTOM COLDDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incb1fae7cc-4033-44bc-aa7c-ca3ceea51c7d2025-11-15WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation1affbef6-dd27-40c2-a5d3-b121aa62496a2025-11-15WarningsExact identifier
application number: M012
Cold and Flu Day, NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Companyb9adfb5d-6576-4ff8-a7d7-a89b867c52922025-11-14WarningsExact identifier
application number: M012
PECGEN DMXDEXTROMETHORPHAN HBR, GUAIFENESINKRAMER NOVISa627824c-5e3d-4672-a047-6c801b50b4322025-11-14WarningsExact identifier
application number: M012
Supress DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINKRAMER NOVIS7da0611e-729c-4cf8-88f3-f8877b9f5cfa2025-11-14WarningsExact identifier
application number: M012
G-ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Novisc1aa7060-0f32-4ea1-8e2e-1aa131bd55fc2025-11-14WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634564{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } PackGPCKceb342da-ff6d-4c19-9f78-0033d028075e3
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSNceb342da-ff6d-4c19-9f78-0033d028075e3
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNceb342da-ff6d-4c19-9f78-0033d028075e3
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNceb342da-ff6d-4c19-9f78-0033d028075e3
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDceb342da-ff6d-4c19-9f78-0033d028075e3
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDceb342da-ff6d-4c19-9f78-0033d028075e3
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSYceb342da-ff6d-4c19-9f78-0033d028075e3
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYceb342da-ff6d-4c19-9f78-0033d028075e3
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYceb342da-ff6d-4c19-9f78-0033d028075e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-056-00722880056008 in 1 CARTONHistorical
72288-580-72722880580721 KIT in 1 CARTON (72288-580-72) * 8 BLISTER PACK in 1 CARTON (72288-056-00) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON (72288-994-00) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 kit2021-08-260000-00-00NoNoCurrent
72288-994-007228809940016 in 1 CARTONHistorical