FDA.reportPublic FDA data

Sinus Pressure plus Pain PE

Product NDC
63941-220
11-digit product format
639410220
Labeler code
63941
Product ID
63941-220_45b2aec3-f5bc-5dd2-e063-6294a90aaa60
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
VALU MERCHANDISERS COMPANY
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-01
Marketing end
2027-07-31
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 Pressure plus Pain PE

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 04JA59TNSJ
Rxcui1046378

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
63941-220-06Sinus Pressure plus Pain PE2 in 1 CARTONTABLET, COATED24
63941-220-06Sinus Pressure plus Pain PE12 in 1 BLISTER PACKTABLET, COATED124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-220SINUS PRESSURE PLUS PAIN PE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [VALU MERCHANDISERS COMPANY]3Current NDC, Legacy NDC, 2 package rows20241017_72847721-9f59-4af1-8f20-dc8449742918.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSN72847721-9f59-4af1-8f20-dc84497429184
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD72847721-9f59-4af1-8f20-dc84497429184
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSY72847721-9f59-4af1-8f20-dc84497429184

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-220-06639410220062 BLISTER PACK in 1 CARTON (63941-220-06) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2020-10-012027-07-31NoNoCurrent