DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF

Product NDC
58602-768
11-digit product format
586020768
Labeler code
58602
Product ID
58602-768_12935a14-0466-9d9f-e063-6294a90a949c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurohealth LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-31
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN
9D2RTI9KYHDEXTROMETHORPHAN HYDROBROMIDE6700-34-1DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJPHENYLEPHRINE HYDROCHLORIDE61-76-7PHENYLEPHRINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-768-155860207681516 CAPSULE in 1 BOTTLE (58602-768-15) 16 capsule2019-12-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DAYTIME COLD AND FLU Multi-Symptom Relief Drug FactsAurohealth LLC | APL HEALTHCARE LIMITED2024-03-01HUMAN OTC DRUG LABEL3