FDA.reportPublic FDA data

Sinus Pressure and Congestion Relief PE

Product NDC
11822-4530
11-digit product format
118224530
Labeler code
11822
Product ID
11822-4530_ccdb8082-3098-43a0-872b-39a4d649605b
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-01-14
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 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 Pressure and Congestion Relief PE
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049182Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fccea3c5-42af-4939-82bc-d9409b75f91fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-4530-2Sinus Pressure and Congestion Relief PEMaximum Strength3 in 1 CARTONTABLET, FILM COATED320
11822-4530-2Sinus Pressure and Congestion Relief PEMaximum Strength24 in 1 BLISTER PACKTABLET, FILM COATED2420
11822-4530-4Sinus Pressure and Congestion Relief PEMaximum Strength1 in 1 CARTONTABLET, FILM COATED120
11822-4530-4Sinus Pressure and Congestion Relief PEMaximum Strength18 in 1 BLISTER PACKTABLET, FILM COATED1820
11822-4530-7Sinus Pressure and Congestion Relief PEMaximum Strength18 in 1 BLISTER PACKTABLET, FILM COATED1820
11822-4530-7Sinus Pressure and Congestion Relief PEMaximum Strength2 in 1 CARTONTABLET, FILM COATED220

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]7
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]7
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GSINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]7
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-4530SINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION]19Current NDC, Legacy NDC, 6 package rows20250512_fccea3c5-42af-4939-82bc-d9409b75f91f.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 5 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corp5afb242f-fac9-dc81-e063-6394a90a84482026-08-27WarningsExact identifier
application number: M012
daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEAmazon.com Services LLC6de619d3-0ab0-43e7-8dac-7bbd5368ac652026-08-27WarningsExact identifier
application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCIWalgreens366ddac8-9e8a-41bd-a7f7-48213485a5f82026-08-27WarningsExact identifier
application number: M012
Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens37896933-3ed3-457f-8a32-ee0d784a19e82026-08-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC298e9164-e378-4b39-a944-bfc8f8baa4de2026-08-27WarningsExact identifier
application number: M012
DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum StrengthDAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, NIGHTTIME ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCIWalgreens3b4b3b04-eff9-4e06-8b37-f6729671d07f2026-08-27WarningsExact identifier
application number: M012
Daytime Cold and Flu mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpdfb0fe2e-b0c7-409a-bd1a-fd12485665ba2026-08-26WarningsExact identifier
application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corp70c5517d-be4e-4317-b4f4-df660c71c6992026-08-26WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d2026-08-26WarningsExact identifier
application number: M012
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSEACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5b95905e-b729-4caf-921a-fc4ef815289c2026-08-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Incc88e93d4-66b6-4327-b9e5-0e0a95a18d662026-08-25WarningsExact identifier
application number: M012
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4fff664b-4ff0-4007-95ab-cb273807b9b42026-08-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company7d972559-6184-476b-9cbf-1bc5663ea00d2026-08-24WarningsExact identifier
application number: M012
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
application number: M012
Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATEKenvue Brands LLC594f515c-b369-816d-e063-6294a90a59a12026-08-21WarningsExact identifier
application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLC5be4e730-3cd6-414e-a23b-f6cad80887502026-08-21WarningsExact identifier
application number: M012
Mucus Relief DM Cough Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCardinal Health 110, LLC. DBA Leader6304a581-9238-4539-b157-293fc05c173e2026-08-21WarningsExact identifier
application number: M012
COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEHyVee Inc82ead335-d38e-40c3-8031-222bf985a3022026-08-20WarningsExact identifier
application number: M012
HyVee Nighttime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc49818610-bf4a-fb86-e063-6294a90ae5982026-08-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSNfccea3c5-42af-4939-82bc-d9409b75f91f20
1049182phenylephrine hydrochloride 10 MG Oral TabletSCDfccea3c5-42af-4939-82bc-d9409b75f91f20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-4530-2118224530023 BLISTER PACK in 1 CARTON (11822-4530-2) / 24 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2005-01-140000-00-00NoNoCurrent
11822-4530-4118224530041 BLISTER PACK in 1 CARTON (11822-4530-4) / 18 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2005-01-140000-00-00NoNoCurrent
11822-4530-7118224530072 BLISTER PACK in 1 CARTON (11822-4530-7) / 18 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-01-140000-00-00NoNoCurrent