Sinus Severe

Product NDC
63941-275
11-digit product format
639410275
Labeler code
63941
Product ID
63941-275_9fb167ca-44bb-4c2c-a257-ae683ec45e8f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Valu Merchandisers Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-08
Marketing end
2027-09-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sinus Severe

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-275-08Sinus Severe12 in 1 BLISTER PACKTABLET, FILM COATED125
63941-275-08Sinus Severe2 in 1 CARTONTABLET, FILM COATED25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-275SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALU MERCHANDISERS COMPANY]3Current NDC, 2 package rows20240825_cdcb8e0d-7847-4f28-bb09-7dc7b5d35c13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNcdcb8e0d-7847-4f28-bb09-7dc7b5d35c135
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDcdcb8e0d-7847-4f28-bb09-7dc7b5d35c135
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYcdcb8e0d-7847-4f28-bb09-7dc7b5d35c135
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYcdcb8e0d-7847-4f28-bb09-7dc7b5d35c135

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-275-08639410275082 BLISTER PACK in 1 CARTON (63941-275-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2023-08-082027-09-30NoNoHistorical