Sinus Congestion and Pain Relief

Product NDC
50844-664
11-digit product format
508440664
Labeler code
50844
Product ID
50844-664_f54d43ba-27b8-4aca-8639-a34b5b64980e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-07-26
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNON-DROWSY SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJNON-DROWSY SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNON-DROWSY SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVNON-DROWSY SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNON-DROWSY SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNON-DROWSY SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNON-DROWSY SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANON-DROWSY SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NON-DROWSY SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ENON-DROWSY SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NON-DROWSY SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNON-DROWSY SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4NON-DROWSY SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UNON-DROWSY SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNON-DROWSY SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-664SINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]13Legacy NDC20240625_c668d527-829d-4649-aa3c-06a3fc51acc6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-664-08508440664082 BLISTER PACK in 1 CARTON (50844-664-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-07-260000-00-00NoNoCurrent