FDA.reportPublic FDA data

Sinus Pressure plus Pain PE

Product NDC
36800-320
11-digit product format
368000320
Labeler code
36800
Product ID
36800-320_285fe11f-9255-5cbd-e063-6394a90a5afb
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-18
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

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 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
36800-320-06Sinus Pressure plus Pain PE12 in 1 BLISTER PACKTABLET, COATED123
36800-320-06Sinus Pressure plus Pain PE2 in 1 CARTONTABLET, COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-320SINUS PRESSURE PLUS PAIN PE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 2 package rows20241205_a9640e09-369c-3c55-e053-2a95a90aebd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNa9640e09-369c-3c55-e053-2a95a90aebd53
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDa9640e09-369c-3c55-e053-2a95a90aebd53
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYa9640e09-369c-3c55-e053-2a95a90aebd53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-320-06368000320062 BLISTER PACK in 1 CARTON (36800-320-06) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2021-06-180000-00-00NoNoCurrent