Day Time Cold and Flu

Product NDC
21130-580
11-digit product format
211300580
Labeler code
21130
Product ID
21130-580_89e8fa16-fee0-4f12-b10e-30d103ade994
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Dextromethorphan HBr Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Safeway, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 mg/15mL; mg/15mL; mg/15mL
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
21130-580-0821130058008237 mL in 1 BOTTLE, PLASTIC (21130-580-08) 237 ml2025-12-01NoNoHistorical
21130-580-1221130058012355 mL in 1 BOTTLE, PLASTIC (21130-580-12) 355 ml2025-12-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsSafeway, Inc.2025-11-05HUMAN OTC DRUG LABEL1