FDA.reportPublic FDA data

DayTime NightTime Cold and Flu Relief

Product NDC
81179-803
11-digit product format
811790803
Labeler code
81179
Product ID
81179-803_d18d3bbe-e9de-2253-e053-2a95a90aec8c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
Dosage form
KIT
Labeler
YET HEALTH GROUP LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-09-02
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct81179-803IInactivated by FDA2026-10-05
excluded packagepackage81179-80381179-803-01IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

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
81179-044-01DayTime NightTime Cold and Flu Relief40 in 1 BOTTLECAPSULE, LIQUID FILLED406.25 mg6
81179-088-01DayTime NightTime Cold and Flu Relief80 in 1 BOTTLECAPSULE, LIQUID FILLED805 mg6
81179-803-01DayTime NightTime Cold and Flu Relief1 in 1 BOTTLEKIT16
81179-803-01DayTime NightTime Cold and Flu Relief1 in 1 CARTONKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81179-803DAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [YET HEALTH GROUP LLC]6Legacy NDC, 4 package rows20240104_cb04c57a-0564-233d-e053-2995a90a103b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634364{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCKcb04c57a-0564-233d-e053-2995a90a103b6
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackPSNcb04c57a-0564-233d-e053-2995a90a103b6
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSNcb04c57a-0564-233d-e053-2995a90a103b6
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSNcb04c57a-0564-233d-e053-2995a90a103b6
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNcb04c57a-0564-233d-e053-2995a90a103b6
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNcb04c57a-0564-233d-e053-2995a90a103b6
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDcb04c57a-0564-233d-e053-2995a90a103b6
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDcb04c57a-0564-233d-e053-2995a90a103b6
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDcb04c57a-0564-233d-e053-2995a90a103b6
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDcb04c57a-0564-233d-e053-2995a90a103b6
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackSYcb04c57a-0564-233d-e053-2995a90a103b6
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYcb04c57a-0564-233d-e053-2995a90a103b6
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYcb04c57a-0564-233d-e053-2995a90a103b6
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYcb04c57a-0564-233d-e053-2995a90a103b6
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYcb04c57a-0564-233d-e053-2995a90a103b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81179-044-018117900440140 in 1 BOTTLEHistorical
81179-088-018117900880180 in 1 BOTTLEHistorical
81179-803-01811790803011 BOTTLE in 1 CARTON (81179-803-01) > 1 KIT in 1 BOTTLE * 1 CAPSULE, LIQUID FILLED in 1 BOTTLE (81179-044-01) * 80 CAPSULE, LIQUID FILLED in 1 BOTTLE (81179-088-01) 1 bottle2021-09-020000-00-00NoNoCurrent