FDA.reportPublic FDA data

SINUS PAIN AND CONGESTION

Product NDC
59779-779
11-digit product format
597790779
Labeler code
59779
Product ID
59779-779_1d308e10-d973-45eb-84ce-a8c98d61ae9a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl
Dosage form
KIT
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-07-26
NDC exclude flag
No
Listing certified through
2026-12-31
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
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046378Internal RxNorm lookup
1046781Internal RxNorm lookup
2634561Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
697dffdd-5b56-4395-8e69-6b4360d9fdc5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-779-08SINUS PAIN AND CONGESTION1 in 1 CARTONKIT117

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZSINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965USINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
POVIDONESINACTIVE INGREDIENTFZ989GH94ESINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-779SINUS PAIN AND CONGESTION (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]16Current NDC, Legacy NDC, 1 package rows20250129_697dffdd-5b56-4395-8e69-6b4360d9fdc5.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 20 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLC319e84fd-4033-f5eb-e063-6394a90aa2f32026-06-27WarningsExact identifier
application number: M012
HyVee Cough Drops MentholMENTHOLHY-VEE, INC47a6f3c3-a6fa-dd61-e063-6394a90a49652026-06-26WarningsExact identifier
application number: M012
HyVee Cough Drops CherryMENTHOLHY-VEE, INC47a717e9-56b3-e771-e063-6394a90a5c172026-06-26WarningsExact identifier
application number: M012
Calmco Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC5532fd37-cdd6-97ab-e063-6394a90a3c772026-06-26WarningsExact identifier
application number: M012
Dr Kids Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC5533e705-b8d5-71cf-e063-6394a90a20102026-06-26WarningsExact identifier
application number: M012
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine HydrochlorideACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals265f1ce7-160c-4dda-b2e0-b78d68f962bd2026-06-26WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEBryant Ranch Prepackee052b39-1658-4071-b081-5433c87b5e4a2026-06-25WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLDOLGENCORP, LLCfae1499a-7029-4208-8436-4d330347b9152026-06-25WarningsExact identifier
application number: M012
Sinus Pressure and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLDOLGENCORP, LLC4fe8f124-ac80-40b4-8e1d-96709c459a4f2026-06-25WarningsExact identifier
application number: M012
Allergy and Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE91268cd0-c151-4744-a715-a57af3f3a3142026-06-25WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.a3c4b9c3-bdb1-4f79-bee6-1bb6bec215ea2026-06-24WarningsExact identifier
application number: M012
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEcb475e7f-aec1-415d-9770-07cce4e02c072026-06-24WarningsExact identifier
application number: M012
Broncolito ChildrenDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509f5b72-9894-ef44-e063-6394a90a6d072026-06-23WarningsExact identifier
application number: M012
Neo-Synephrine SeverePHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC54edaff7-d241-dc90-e063-6294a90ac64d2026-06-23WarningsExact identifier
application number: M012
AXIV Sinus Severe Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC4b81abf9-3ea7-e996-e063-6394a90a71e82026-06-23WarningsExact identifier
application number: M012
AXIV Sinus OVERNIGHTOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC54e03a63-f978-33d4-e063-6394a90a30f22026-06-23WarningsExact identifier
application number: M012
equaline daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI9a199782-5d7e-449b-a86c-969746f0e96f2026-06-23WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWalgreen Company542b9861-8055-45f6-8cbf-9fe5cde1c4d92026-06-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.3c1953a1-32e9-6c81-e063-6294a90a9fa22026-06-22WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59db2573-7ebb-4cf9-bfe3-428929bb4eeb2026-06-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634561{1 (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } PackGPCK697dffdd-5b56-4395-8e69-6b4360d9fdc517
26345611 daytime (acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral Tablet) PackPSN697dffdd-5b56-4395-8e69-6b4360d9fdc517
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral TabletPSN697dffdd-5b56-4395-8e69-6b4360d9fdc517
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSN697dffdd-5b56-4395-8e69-6b4360d9fdc517
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD697dffdd-5b56-4395-8e69-6b4360d9fdc517
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD697dffdd-5b56-4395-8e69-6b4360d9fdc517
26345611 daytime (acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral Tablet) PackSY697dffdd-5b56-4395-8e69-6b4360d9fdc517
1046781APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSY697dffdd-5b56-4395-8e69-6b4360d9fdc517
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSY697dffdd-5b56-4395-8e69-6b4360d9fdc517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-779-08597790779081 KIT in 1 CARTON (59779-779-08) * 12 TABLET, FILM COATED in 1 BLISTER PACK * 12 TABLET, FILM COATED in 1 BLISTER PACK1 kit2005-07-260000-00-00NoNoCurrent