FDA.reportPublic FDA data

Severe DayTime NightTime Cold and Flu Relief

Product NDC
81179-804
11-digit product format
811790804
Labeler code
81179
Product ID
81179-804_d18d43e4-94ac-17c6-e053-2995a90a1300
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl, Guaifenesin
Dosage form
KIT
Route
ORAL
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 productproduct81179-804IInactivated by FDA2026-10-05
excluded packagepackage81179-80481179-804-02IInactivated 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
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
81179-004-00Severe DayTime NightTime Cold and Flu ReliefMax Strength1 in 1 BOTTLECAPSULE, LIQUID FILLED405 mg6
81179-008-00Severe DayTime NightTime Cold and Flu ReliefMax Strength1 in 1 BOTTLECAPSULE, LIQUID FILLED8010 mg6
81179-804-02Severe DayTime NightTime Cold and Flu ReliefMax Strength1 in 1 BOTTLEKIT16
81179-804-02Severe DayTime NightTime Cold and Flu ReliefMax Strength1 in 1 CARTONKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81179-804SEVERE DAYTIME NIGHTTIME COLD AND FLU RELIEF MAX STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL, GUAIFENESIN) KIT [YET HEALTH GROUP LLC]6Legacy NDC, 4 package rows20240104_cc33f772-a42b-0c11-e053-2995a90a7a23.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) } PackGPCKcc33f772-a42b-0c11-e053-2995a90a7a236
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) PackPSNcc33f772-a42b-0c11-e053-2995a90a7a236
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSNcc33f772-a42b-0c11-e053-2995a90a7a236
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSNcc33f772-a42b-0c11-e053-2995a90a7a236
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDcc33f772-a42b-0c11-e053-2995a90a7a236
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDcc33f772-a42b-0c11-e053-2995a90a7a236
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) PackSYcc33f772-a42b-0c11-e053-2995a90a7a236
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYcc33f772-a42b-0c11-e053-2995a90a7a236
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYcc33f772-a42b-0c11-e053-2995a90a7a236

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81179-004-00811790004001 in 1 BOTTLEHistorical
81179-008-00811790008001 in 1 BOTTLEHistorical
81179-804-02811790804021 BOTTLE in 1 CARTON (81179-804-02) > 1 KIT in 1 BOTTLE * 1 CAPSULE, LIQUID FILLED in 1 BOTTLE (81179-004-00) * 1 CAPSULE, LIQUID FILLED in 1 BOTTLE (81179-008-00) 1 bottle2021-09-020000-00-00NoNoCurrent