Sinus Headache and Pain

Product NDC
55301-446
11-digit product format
553010446
Labeler code
55301
Product ID
55301-446_caa43cfa-0966-4ef7-8300-22435275f771
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-07-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sinus Headache and Pain
Brand name suffix
Day, Non-drowsy
Listing expiration
2027-12-31

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
55301-446-08Sinus Headache and PainDay, Non-drowsy2 in 1 CARTONTABLET, FILM COATED215
55301-446-08Sinus Headache and PainDay, Non-drowsy12 in 1 BLISTER PACKTABLET, FILM COATED1215

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-446SINUS HEADACHE AND PAIN DAY, NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]14Current NDC, Legacy NDC, 2 package rows20250124_c33340c0-47d3-45e2-997b-3d9fb148900f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNc33340c0-47d3-45e2-997b-3d9fb148900f15
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDc33340c0-47d3-45e2-997b-3d9fb148900f15
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYc33340c0-47d3-45e2-997b-3d9fb148900f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-446-08553010446082 BLISTER PACK in 1 CARTON (55301-446-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-07-260000-00-00NoNoCurrent