FDA.reportPublic FDA data

Sinus and Headache

Product NDC
50804-123
11-digit product format
508040123
Labeler code
50804
Product ID
50804-123_24c28a4e-a406-fd8a-e063-6294a90a59e3
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
GOODSENSE
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-01
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 and Headache
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
50804-123-05Sinus and Headache12 in 1 PACKAGETABLET, COATED124
50804-123-05Sinus and Headache2 in 1 CARTONTABLET, COATED24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-123-05EA - Each50804-123cf0f87ab-4d02-4d2a-b0e1-9b0b9ec4829d12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-123SINUS AND HEADACHE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE]4Current NDC, Legacy NDC, 2 package rows20241020_a14999e3-a9d9-0a1f-e053-2995a90af7b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNa14999e3-a9d9-0a1f-e053-2995a90af7b34
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDa14999e3-a9d9-0a1f-e053-2995a90af7b34
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYa14999e3-a9d9-0a1f-e053-2995a90af7b34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50804-123-05508040123052 PACKAGE in 1 CARTON (50804-123-05) / 12 TABLET, COATED in 1 PACKAGE2 package2020-06-010000-00-00NoNoCurrent