Head Congestion plus Flu Severe PE

Product NDC: 63941-274
11-digit product format: 639410274
Labeler code: 63941
Product ID: 63941-274_45b2c593-0e11-3488-e063-6394a90ad6f0
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: VALU MERCHANDISERS COMPANY
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-04-14
Marketing end: 2027-10-31
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 10; 100; 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
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1
GUAIFENESIN	100 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

Field, Values table
Field	Values
Unii	362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui	1098435

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63941-274-02	Head Congestion plus Flu Severe PE	12 in 1 BLISTER PACK	TABLET, COATED	12		4
63941-274-02	Head Congestion plus Flu Severe PE	2 in 1 CARTON	TABLET, COATED	2		4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63941-274	HEAD CONGESTION PLUS FLU SEVERE PE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [VALU MERCHANDISERS COMPANY]	3	Current NDC, 2 package rows	20241017_f6401b58-8cf8-4067-e053-2995a90a68fc.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1098435	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	f6401b58-8cf8-4067-e053-2995a90a68fc	4
1098435	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	f6401b58-8cf8-4067-e053-2995a90a68fc	4
1098435	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 100 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	f6401b58-8cf8-4067-e053-2995a90a68fc	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63941-274-02	63941027402	2 BLISTER PACK in 1 CARTON (63941-274-02) / 12 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2023-04-14	2027-10-31	No	No	Historical