FDA.reportPublic FDA data

DAYTIME COLD AND FLU

Product NDC
79481-0026
11-digit product format
794810026
Labeler code
79481
Product ID
79481-0026_ee27a999-1b92-ad3b-e053-2a95a90a8e33
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
MEIJER, INC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-09-12
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct79481-0026IInactivated by FDA2026-10-05
excluded packagepackage79481-002679481-0026-2IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0026-2DAYTIME COLD AND FLU2 in 1 CARTONCAPSULE, LIQUID FILLED29
79481-0026-2DAYTIME COLD AND FLU12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED129

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0026DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MEIJER, INC]9Legacy NDC, 2 package rows20241222_e45ecd53-d125-435a-a5fb-1ffb8b459dbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNe45ecd53-d125-435a-a5fb-1ffb8b459dbf9
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDe45ecd53-d125-435a-a5fb-1ffb8b459dbf9
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYe45ecd53-d125-435a-a5fb-1ffb8b459dbf9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79481-0026-2794810026022 BLISTER PACK in 1 CARTON (79481-0026-2) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2022-09-120000-00-00YesNoCurrent