FDA.reportPublic FDA data

Sinus Pressure plus Pain PE

Product NDC
72476-120
11-digit product format
724760120
Labeler code
72476
Product ID
72476-120_092d5783-2759-5ae8-e063-6394a90ac1c0
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
RETAIL BUSINESS SERVICES , LLC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-20
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
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 Pressure plus Pain PE
Listing expiration
2026-12-31

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
eb64750f-19ac-655f-e053-2995a90a33b5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-120-06Sinus Pressure plus Pain PE12 in 1 BLISTER PACKTABLET, COATED122
72476-120-06Sinus Pressure plus Pain PE2 in 1 CARTONTABLET, COATED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-120SINUS PRESSURE PLUS PAIN PE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RETAIL BUSINESS SERVICES , LLC.]2Current NDC, 2 package rows20231103_eb64750f-19ac-655f-e053-2995a90a33b5.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 76 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Honey Lemon Cough DropsMENTHOLGeiss, Destin, Dunnc72e557f-0211-81b9-e053-2995a90a14372025-12-12WarningsExact identifier
application number: M012
Good Sense Cherry Benzocaine LozengesBENZOCAINEGeiss, Destin, Dunnc7404c94-09eb-5cc5-e053-2995a90af0212025-12-12WarningsExact identifier
application number: M012
Good Sense SF Honey Lemon Cough DropsMENTHOLGeiss, Destin, Dunne11ed21f-6ceb-5908-e053-2995a90aea462025-12-12WarningsExact identifier
application number: M012
Severe Congestion Relief Maximum Strength SinusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores Inc59918b8b-5c91-468f-834e-66020dc1ae122025-12-12WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLSALADO SALES INC.8f66f5bc-7c77-420b-9feb-911c980fbfdc2025-12-12WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.de55a9fd-53a2-4f3e-82b7-cabcbe287d462025-12-12WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATESALADO SALES INC.cc73b668-cc6a-41d6-800a-4988c59c04492025-12-12WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATECHAIN DRUG MARKETING ASSOCIATION INC75269bcc-3bb2-49a0-8788-6b7da18796d32025-12-12WarningsExact identifier
application number: M012
Suphedrine PE Sinus plus AllergyCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEaffac07f-d645-4999-98ee-7467902f5adc2025-12-12WarningsExact identifier
application number: M012
Sinus Congestion and Pain Relief Non-DrowsyACETAMINOPHEN, PHENYLEPHRINE HCLWinCo Foods, LLCf7e925f4-7da6-4157-a97f-e6a3e399911f2025-12-11WarningsExact identifier
application number: M012
Sinus Relief Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH645f8075-e33f-4e1a-9249-7368261cdcb92025-12-11WarningsExact identifier
application number: M012
Geri-TussinGUAIFENESINGeri-Care Pharmaceuticals, Corp8fd0071b-c6ca-49e6-b159-45dead71b6642025-12-11WarningsExact identifier
application number: M012
Geri-Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp098582dc-3e12-782f-e063-6394a90aa1a12025-12-11WarningsExact identifier
application number: M012
GUAIASORB DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp09866b9c-aa32-45eb-e063-6394a90a49032025-12-11WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYd6947661-a6dd-4bc4-a0ca-932db1840f582025-12-11WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY2e751d67-51b4-4b74-a9e8-7f3bc56369842025-12-11WarningsExact identifier
application number: M012
Pressure and Pain Plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY232acb86-7383-4992-b333-1e47bf7c06ad2025-12-11WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY72847721-9f59-4af1-8f20-dc84497429182025-12-11WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf6401317-0295-14b3-e053-2a95a90acbb42025-12-11WarningsExact identifier
application number: M012
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf6401b58-8cf8-4067-e053-2995a90a68fc2025-12-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNeb64750f-19ac-655f-e053-2995a90a33b52
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDeb64750f-19ac-655f-e053-2995a90a33b52
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYeb64750f-19ac-655f-e053-2995a90a33b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72476-120-06724760120062 BLISTER PACK in 1 CARTON (72476-120-06) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2023-01-20NoNoCurrent