FDA.reportPublic FDA data

Sinus PE plus Allergy

Product NDC
59779-962
11-digit product format
597790962
Labeler code
59779
Product ID
59779-962_b9a4683d-9b16-4d77-a766-fc1c5846391a
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate, Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-06-09
Substance
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
4; 10 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 plus Allergy
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

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
59779-962-08Sinus PE plus AllergyMaximum Strength1 in 1 CARTONTABLET115
59779-962-08Sinus PE plus AllergyMaximum Strength24 in 1 BLISTER PACKTABLET2415

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-962-08EA - Each59779-9622e43b920-3235-459a-ad34-9873c938497812020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZSINUS PE PLUS ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS PE PLUS ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965USINUS PE PLUS ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS PE PLUS ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINUS PE PLUS ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SINUS PE PLUS ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSINUS PE PLUS ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SINUS PE PLUS ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SINUS PE PLUS ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSINUS PE PLUS ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-962SINUS PE PLUS ALLERGY MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [CVS PHARMACY]14Current NDC, Legacy NDC, 2 package rows20250512_b389f438-08d3-44e0-86a4-e34d12f018f8.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 151 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough DropsMENTHOLUnited Natural Foods, Inc.f9f0d020-e031-245e-e053-6294a90addb52024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7ee463-8003-a306-e053-6294a90a82592024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7e4a84-d2c2-65e5-e053-6394a90a0c722024-10-08WarningsExact identifier
application number: M012
Cough DropsCHERRYUnited Natural Foods, Inc.f9f0e853-6997-a49b-e053-6294a90aa4b82024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7fa728-911d-aaf0-e053-6394a90ace312024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7f3b84-1e61-eadf-e053-6394a90a9e5c2024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7f515f-7302-d153-e053-6394a90a08342024-10-08WarningsExact identifier
application number: M012
Rompe Pecho NT NTACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEEfficient Laboratories Inc06faafaa-50a6-c16e-e063-6294a90a49cb2024-10-08WarningsExact identifier
application number: M012
Mucus Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRBryant Ranch Prepack8c25285e-e2cd-4e10-af63-5dce8098b6152024-10-08WarningsExact identifier
application number: M012
Severe Throat Sore DropsMENTHOLTarget Corporation Inc.949543d5-5043-ac06-e053-2995a90ab3982024-10-07WarningsExact identifier
application number: M012
Natural Herbal Cough DropsCOUGH DROPSTarget Corporation Inc.a23ddfa9-19e0-99ee-e053-2a95a90a68562024-10-07WarningsExact identifier
application number: M012
Cough DropsSIMPLY MENTHOL COUGH DROPSPerrigo Direct, Inc.fb809c63-94f1-bb7a-e053-6294a90a0a392024-10-07WarningsExact identifier
application number: M012
Cough DropsSIMPLY CHERRY COUGH DROPSPerrigo Direct, Inc.fb808dc5-bf63-836c-e053-6294a90a80aa2024-10-07WarningsExact identifier
application number: M012
Cough DropsSIMPLY HONEY LEMONPerrigo Direct Inc.fb898616-d604-b4c3-e053-6294a90a23bf2024-10-07WarningsExact identifier
application number: M012
Natural Herb Cough DropsMENTHOL HERBCVS Pharmacyfcd16063-abca-49a0-e053-6294a90acb262024-10-07WarningsExact identifier
application number: M012
Lemon Mint Herb Throat DropsSUGAR FREE LEMON MINT HERBCVS Pharmacyfce6b5fa-846d-9911-e053-6294a90afc9b2024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLCVS Pharmacyfcd053e9-92ef-70ba-e053-6294a90aa4dd2024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsHONEY LEMONCVS Pharmacyf074a64d-dc01-1a37-e053-2995a90adc492024-10-07WarningsExact identifier
application number: M012
Cough DropsHONEY LEMONCVS Pharmacyf075010d-a07a-5e9d-e053-2995a90a3ca32024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsHONEY LEMONCVS Pharmacyfcd053e9-92ee-70ba-e053-6294a90aa4dd2024-10-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090443chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral TabletPSNb389f438-08d3-44e0-86a4-e34d12f018f815
1090443chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSCDb389f438-08d3-44e0-86a4-e34d12f018f815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-962-08597790962081 BLISTER PACK in 1 CARTON (59779-962-08) / 24 TABLET in 1 BLISTER PACK1 blister pack2005-06-090000-00-00NoNoCurrent