SINUS PAIN AND CONGESTION

Product NDC: 59779-466
11-digit product format: 597790466
Labeler code: 59779
Product ID: 59779-466_7ecd64a3-bc97-40ba-bc5a-77a47712a780
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen and Phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: CVS Pharmacy
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-07-26
Substance: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 5 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: SINUS PAIN AND CONGESTION
Brand name suffix: DAYTIME
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59779-466-08	SINUS PAIN AND CONGESTIONDAYTIME	2 in 1 CARTON	TABLET, FILM COATED	2		21
59779-466-08	SINUS PAIN AND CONGESTIONDAYTIME	12 in 1 BLISTER PACK	TABLET, FILM COATED	12		21

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	7
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	7
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	7
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	7
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	7
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-466	SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	20	Current NDC, Legacy NDC, 2 package rows	20241206_c878c7aa-c591-4bae-a1d1-842eaf27c5b1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 177 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief Immediate Release	GUAIFENESIN 400MG	TopCo Associates, LLC	7d91c6ab-d161-42b9-b353-0aa8f59619f8	2021-01-21	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MG	Allegiant Health	bed5f9dc-45ea-4e90-86c6-86599b6f3861	2020-11-16	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN	Allegiant Health	b97126d7-847d-483e-b3d1-e2b61ab1743f	2020-11-11	Warnings	Exact identifier application number: M012
Cold and Allergy	PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE	Allegiant Health	7af63769-fa56-4f1f-a2ad-5b4c108c8e4f	2019-12-12	Warnings	Exact identifier application number: M012
Mucus Relief Immediate Release	GUAIFENESIN	Allegiant Health	221d64a2-b8c7-435a-aae4-fb58fd38108f	2019-03-26	Warnings	Exact identifier application number: M012
Sleep Tabs For Nighttime use	DIPHENHYDRAMINE HCL TABLETS	Allegiant Health	566e40b1-e9d7-44e4-b971-eef2b7cf0a7d	2018-12-26	Warnings	Exact identifier application number: M012
Allergy	CHLORPHENIRAMINE MALEATE	Allegiant Health	4305ad50-d2a5-4d3e-9d92-cbf26e856a16	2018-12-26	Warnings	Exact identifier application number: M012
Sleep Aid	DIPHENHYDRAMINE HCL 25 MG	Allegiant Health	dbbc535f-515a-4d9b-b799-34e60f5230bb	2018-12-21	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL	Allegiant Health	c2823bad-540f-4662-8dcc-58e9f0d94efb	2018-11-07	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength Non-Drowsy	PHENYLEPHRINE 10 MG	Allegiant Health	7aef00df-816a-4ea2-a2ad-beed66dd2fe4	2018-11-07	Warnings	Exact identifier application number: M012
DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	a58bfb14-28f9-4425-a5a5-aaff4847c979	2018-03-14	Warnings	Exact identifier application number: M012
Chlorpheniramine maleate 4mg	CHLORPHENIRAMINE MALEATE 4MG	Athlete's Needs, Inc.	4d974959-25fc-4707-9b72-9afbf47b76f1	2017-11-14	Warnings	Exact identifier application number: M012
Cold Medicine	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Selder, S.A. de C.V.	d2762d9c-e7e7-42b2-a26a-14b2aa0307cb	2017-01-25	Warnings	Exact identifier application number: M012
Allergy	CHLORPHENIRAMINE MALEATE	Marc Glassman, Inc.	2051247f-ce64-4cf5-b449-9ca14c43ab86	2016-12-27	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046378	acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	c878c7aa-c591-4bae-a1d1-842eaf27c5b1	21
1046378	acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	c878c7aa-c591-4bae-a1d1-842eaf27c5b1	21
1046378	APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	c878c7aa-c591-4bae-a1d1-842eaf27c5b1	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-466-08	59779046608	2 BLISTER PACK in 1 CARTON (59779-466-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2005-07-26	0000-00-00	No	No	Current