FDA.reportPublic FDA data

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
IngredientStrength
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-466-08SINUS PAIN AND CONGESTIONDAYTIME2 in 1 CARTONTABLET, FILM COATED221
59779-466-08SINUS PAIN AND CONGESTIONDAYTIME12 in 1 BLISTER PACKTABLET, FILM COATED1221

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]7
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]7
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]7
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]7
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]7
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]7
TALCINACTIVE INGREDIENT7SEV7J4R1USINUS 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
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-466SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]20Current NDC, Legacy NDC, 2 package rows20241206_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 87 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens Allergy Dye Free Wal DrylDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN CO.4e64e040-1662-4dc9-b33f-3e119e0b3f7b2025-11-25WarningsExact identifier
application number: M012
WalgreenNASALWALGREENS COd38f8406-d7b9-472c-a472-58968bbdb9932025-11-25WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC780907b8-34ba-4ec8-bcdf-b2a31bd111df2025-11-25WarningsExact identifier
application number: M012
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCd13efbcd-1277-45d0-8389-1ba0337f7a242025-11-25WarningsExact identifier
application number: M012
Childrens Robitussin Elderberry Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCfe903448-b422-42e0-b05b-aeb3e5481e3c2025-11-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC1d4fcb76-22d1-7292-e063-6394a90af9202025-11-25WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGH Soft CHEWSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLCf22248b7-7abd-4df7-a986-dae357ebe8f12025-11-25WarningsExact identifier
application number: M012
ROBITUSSIN Nighttime Cough DM Soft CHEWSDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHaleon US Holdings LLC39468746-e06d-4849-9d06-9af4d14351b02025-11-25WarningsExact identifier
application number: M012
Daytime and Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEGrocery Outlet, Inc.4478fd51-bae3-6108-e063-6394a90a07ca2025-11-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INC.395bb39a-e26f-f4f2-e063-6394a90ae7212025-11-25WarningsExact identifier
application number: M012
day timeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEH E Beaf3af6a-de5b-43fe-83ff-9641646e0f6b2025-11-25WarningsExact identifier
application number: M012
MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid GelsACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERB Health (US) LLC38571853-992f-9998-e063-6394a90a85812025-11-24WarningsExact identifier
application number: M012
Basic Care Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLCe19b561c-fb76-4355-a306-d3dc46930bf22025-11-24WarningsExact identifier
application number: M012
Sinus DecongestionPSEUDOEPHEDRINE HCLKroger Company73c3a9ac-43d6-4ecd-9add-36ca1c40ba9c2025-11-24WarningsExact identifier
application number: M012
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCICardinal Health (Leader) 7000014c507df-fbac-4a09-a66c-b91c2abbf5502025-11-24WarningsExact identifier
application number: M012
Severe Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCIFamily Dollar (FAMILY WELLNESS)e5c90d6e-70aa-4886-bc81-293e0dcf56382025-11-24WarningsExact identifier
application number: M012
Throat Coat Eucalyptus MintMENTHOLTraditional Medicinals, Inc.a7a86f1b-30e8-6f5d-e053-2a95a90a2a822025-11-21WarningsExact identifier
application number: M012
Throat Coat Sweet Orange FennelMENTHOLTraditional Medicinals, Inc.4538248f-11cc-d6b2-e063-6294a90a652c2025-11-21WarningsExact identifier
application number: M012
up and up Daytime Nighttime Childrens Multi Symptom ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationb8a4da0b-e4d3-48e6-b699-cb56c7b67ed72025-11-20WarningsExact identifier
application number: M012
Supress DX Pediatric DropsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVISddb95436-7806-4086-af4d-18a6625b5c832025-11-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNc878c7aa-c591-4bae-a1d1-842eaf27c5b121
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDc878c7aa-c591-4bae-a1d1-842eaf27c5b121
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYc878c7aa-c591-4bae-a1d1-842eaf27c5b121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-466-08597790466082 BLISTER PACK in 1 CARTON (59779-466-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-07-260000-00-00NoNoCurrent