FDA.reportPublic FDA data

Sinus PE Pressure plus Pain

Product NDC
59779-802
11-digit product format
597790802
Labeler code
59779
Product ID
59779-802_7a903151-4f47-4111-b0f1-5c716c3d7651
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-06-23
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 PE Pressure plus Pain
Brand name suffix
MAXIMUM STRENGTH
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a3b073b4-494c-4531-b08e-475c86ba321dAvailable 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
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-802-08Sinus PE Pressure plus PainMAXIMUM STRENGTH2 in 1 CARTONTABLET216
59779-802-08Sinus PE Pressure plus PainMAXIMUM STRENGTH12 in 1 BLISTER PACKTABLET1216

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-802SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [CVS PHARMACY]14Current NDC, Legacy NDC, 2 package rows20240727_a3b073b4-494c-4531-b08e-475c86ba321d.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 169 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Sinus Relief MistOXYMETAZOLINE SPRAYWalgreens Company847f47d9-62b1-49a3-8bb3-9bf275685bd22024-02-14WarningsExact identifier
application number: M012
Allergy Sinus, Lil Drug StoreACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATELil' Drug Store Products, Inc.1145440e-b37a-6e5e-e063-6294a90ab4a02024-02-13WarningsExact identifier
application number: M012
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEA-S Medication Solutions36140639-e7a8-43bc-83e2-469430af9d1a2024-02-13WarningsExact identifier
application number: M012
Theraflu ExpressMax Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCff48b55a-0d32-47d6-941d-d99c7cf52f942024-02-12WarningsExact identifier
application number: M012
Childrens Robitussin Cough and Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINHaleon US Holdings LLC15950273-14c9-4a0b-bbb4-683048add7222024-02-08WarningsExact identifier
application number: M012
THERAFLU Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLC7d902237-a990-4c5e-875b-291e124e143b2024-02-03WarningsExact identifier
application number: M012
Tussin Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINBest Choice (Valu Merchandisers Company)0f2d371d-f890-41e5-ac11-db5559d324662024-02-02WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC4daca846-8511-4303-9e6c-9469f7f260ba2024-02-02WarningsExact identifier
application number: M012
CVS Health COUGH SUPPRESSANT SOFTGELDEXTROMETHORPHAN HYDROBROMIDECVS Pharmacy, Inc.f676dfeb-fba8-419d-8a47-c3880e4100cc2024-02-02WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReadyInCaseACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLC155a7168-b568-41f4-b8a2-214889b4eccf2024-02-02WarningsExact identifier
application number: M012
Vaporizing Chest Rub Lavender 4ozCAMPHOR/MENTHOLRejoice International Corp.104e1a38-3472-b9e2-e063-6294a90a38cf2024-02-01WarningsExact identifier
application number: M012
Vaporizing Chest Rub Lavender 4ozCAMPHOR/MENTHOLChina Ningbo Shangge Cosmetics Technology Corp.104f5b07-eed2-566c-e063-6294a90a65052024-02-01WarningsExact identifier
application number: M012
CHILDRENS COLD COUGH and SORE THROAT MIXED BERRYACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.5962a73e-72e4-493b-94a7-43bc6cf9c82f2024-02-01WarningsExact identifier
application number: M012
good sense allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEL. Perrigo Company2cfa69b4-e33f-442a-a6df-b021b041da142024-02-01WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCLHaleon US Holdings LLCe5ef7b85-feee-44a7-bd0e-ed91352c74342024-01-31WarningsExact identifier
application number: M012
SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.17a07d2d-f2da-4e51-9a77-6f0c174987bb2024-01-31WarningsExact identifier
application number: M012
Maximum strength Max Cold and SinusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.263dae13-5f92-4505-8bcc-e903d05b9a0c2024-01-31WarningsExact identifier
application number: M012
THERAFLU POWERPODS NIGHTTIME SEVERE COLDACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC39f9feef-4bf2-4f10-9fff-22bbb1d8a4712024-01-30WarningsExact identifier
application number: M012
Theraflu Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEHaleon US Holdings LLCc0689223-5c90-4dbc-bbfa-f94e267504c32024-01-28WarningsExact identifier
application number: M012
THERAFLU MULTI-SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCa4c56ca0-7785-404b-996d-137cc135f2702024-01-28WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNa3b073b4-494c-4531-b08e-475c86ba321d16
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDa3b073b4-494c-4531-b08e-475c86ba321d16
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYa3b073b4-494c-4531-b08e-475c86ba321d16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-802-08597790802082 BLISTER PACK in 1 CARTON (59779-802-08) / 12 TABLET in 1 BLISTER PACK2 blister pack2005-06-230000-00-00NoNoCurrent