FDA.reportPublic FDA data

PE Sinus Congestion

Product NDC
36800-704
11-digit product format
368000704
Labeler code
36800
Product ID
36800-704_7f3d19c8-f2ae-44b1-932c-da72a3269088
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-15
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

Additional Listing Data#

Finished product
Yes
Brand name base
PE Sinus Congestion
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ
Rxcui1049182

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-704-07PE Sinus Congestion2 in 1 CARTONTABLET, FILM COATED26
36800-704-07PE Sinus Congestion18 in 1 BLISTER PACKTABLET, FILM COATED186
36800-704-29PE Sinus Congestion150 in 1 BOTTLE, PLASTICTABLET, FILM COATED1506
36800-704-29PE Sinus Congestion1 in 1 CARTONTABLET, FILM COATED16
36800-704-44PE Sinus Congestion1 in 1 CARTONTABLET, FILM COATED16
36800-704-44PE Sinus Congestion18 in 1 BLISTER PACKTABLET, FILM COATED186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-704PE SINUS CONGESTION (PHENYLEPHRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES, LLC]5Current NDC, Legacy NDC, 6 package rows20250130_3264e291-7a0f-4e25-8390-ba441f22f650.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSN3264e291-7a0f-4e25-8390-ba441f22f6506
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD3264e291-7a0f-4e25-8390-ba441f22f6506

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-704-07368000704072 BLISTER PACK in 1 CARTON (36800-704-07) / 18 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2022-03-150000-00-00NoNoCurrent
36800-704-29368000704291 BOTTLE, PLASTIC in 1 CARTON (36800-704-29) / 150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2022-03-150000-00-00NoNoCurrent
36800-704-44368000704441 BLISTER PACK in 1 CARTON (36800-704-44) / 18 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2022-03-150000-00-00NoNoCurrent