FDA.reportPublic FDA data

Nightime Cold and Flu

Product NDC
79481-0027
11-digit product format
794810027
Labeler code
79481
Product ID
79481-0027_ee27b8fa-a3ee-5ef4-e053-2995a90ab8c9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Meijer, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-09-15
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
325 mg/1; mg/1; mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 productproduct79481-0027IInactivated by FDA2026-10-05
excluded packagepackage79481-002779481-0027-2IInactivated 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
79481-0027-2Nightime Cold and Flu2 in 1 CARTONCAPSULE, LIQUID FILLED26
79481-0027-2Nightime Cold and Flu12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0027NIGHTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MEIJER, INC.]6Legacy NDC, 2 package rows20241222_eac91dcf-ff2a-4131-9fca-c12af71d757e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNeac91dcf-ff2a-4131-9fca-c12af71d757e6
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDeac91dcf-ff2a-4131-9fca-c12af71d757e6
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYeac91dcf-ff2a-4131-9fca-c12af71d757e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79481-0027-2794810027022 BLISTER PACK in 1 CARTON (79481-0027-2) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2022-09-150000-00-00NoNoCurrent