FDA.reportPublic FDA data

Sinus Severe

Product NDC
79481-7250
11-digit product format
794817250
Labeler code
79481
Product ID
79481-7250_6406edfe-8b49-4356-a556-2433d1aebd9f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Meijer Distribution, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-11
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 Severe
Brand name suffix
Non Drowsy, Daytime
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 495W7451VQ, 04JA59TNSJ
Rxcui1243679

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-7250-8Sinus SevereNon Drowsy, Daytime12 in 1 BLISTER PACKTABLET, FILM COATED126
79481-7250-8Sinus SevereNon Drowsy, Daytime2 in 1 CARTONTABLET, FILM COATED26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-7250SINUS SEVERE NON DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION, INC.]5Current NDC, 2 package rows20240828_84c30ec9-a7b5-4d2f-95b2-d6fb895945de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN84c30ec9-a7b5-4d2f-95b2-d6fb895945de6
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD84c30ec9-a7b5-4d2f-95b2-d6fb895945de6
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY84c30ec9-a7b5-4d2f-95b2-d6fb895945de6
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY84c30ec9-a7b5-4d2f-95b2-d6fb895945de6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-7250-8794817250082 BLISTER PACK in 1 CARTON (79481-7250-8) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2024-06-11NoNoCurrent