Sinus Congestion and Pain Relief

Product NDC
11822-0588
11-digit product format
118220588
Labeler code
11822
Product ID
11822-0588_3d0b4b4b-6631-42f5-85ae-3d706b84da6d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Phenylephrine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-03-17
Marketing end
2026-11-22
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sinus Congestion and Pain Relief
Brand name suffix
Non-Drowsy, Daytime

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 04JA59TNSJ

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
11822-0588-4Sinus Congestion and Pain ReliefNon-Drowsy, Daytime1 in 1 CARTONTABLET, COATED127
11822-0588-4Sinus Congestion and Pain ReliefNon-Drowsy, Daytime2 in 1 BLISTER PACKTABLET, COATED227
11822-0588-7Sinus Congestion and Pain ReliefNon-Drowsy, Daytime30 in 1 BLISTER PACKTABLET, COATED3027
11822-0588-7Sinus Congestion and Pain ReliefNon-Drowsy, Daytime1 in 1 CARTONTABLET, COATED127
11822-0588-8Sinus Congestion and Pain ReliefNon-Drowsy, Daytime2 in 1 CARTONTABLET, COATED227
11822-0588-8Sinus Congestion and Pain ReliefNon-Drowsy, Daytime12 in 1 BLISTER PACKTABLET, COATED1227

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]7
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]7
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]7
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]7
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0588SINUS CONGESTION AND PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, COATED [RITE AID CORPORATION]27Current NDC, Legacy NDC, 6 package rows20250131_8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0588-4118220588041 BLISTER PACK in 1 CARTON (11822-0588-4) > 2 TABLET, COATED in 1 BLISTER PACK1 blister pack2008-03-172023-03-12NoNoCurrent
11822-0588-71182205880730 in 1 BLISTER PACKHistorical
11822-0588-8118220588082 BLISTER PACK in 1 CARTON (11822-0588-8) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2008-03-172026-11-22NoNoCurrent