Mucus Relief Sinus Pressure Pain and Cough

Product NDC
53943-199
11-digit product format
539430199
Labeler code
53943
Product ID
53943-199_24af1010-2770-9676-e063-6394a90a8021
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
495W7451VQGUAIFENESIN93-14-1GUAIFENESIN
04JA59TNSJPHENYLEPHRINE HYDROCHLORIDE61-76-7PHENYLEPHRINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53943-199-02539430199022 BLISTER PACK in 1 CARTON (53943-199-02) / 10 TABLET, COATED in 1 BLISTER PACK2 blister pack2021-02-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
1199-DDM-2021-0219DISCOUNT DRUG MART2024-10-17HUMAN OTC DRUG LABEL4