Sinus Relief Severe Congestion

Product NDC
0363-0478
11-digit product format
003630478
Labeler code
0363
Product ID
0363-0478_820af596-8f6b-4390-af42-2e4fe3862cea
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Walgreens
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-08-31
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 mg/20mL; mg/20mL; mg/20mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0478-062023-10-10C16284748780-1f386c64a-1498-0266-e053-dadaa90a7c1a38a31de8-3539-4af5-8bcc-176da188a2ac
0363-0478-062023-01-30C16284748780-1f386c64a-1498-0266-e053-dadaa90a7c1a38a31de8-3539-4af5-8bcc-176da188a2ac

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0478-06ML - Milliliter0363-04785218ffef-7a50-48b7-8904-802fe47abf3412022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
GUAIFENESINACTIVE INGREDIENT495W7451VQSINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
GUAIFENESINACTIVE MOIETY495W7451VQSINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92SINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
SORBITOLINACTIVE INGREDIENT506T60A25RSINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4SINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KSINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
WATERINACTIVE INGREDIENT059QF0KO0RSINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0478SINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [WALGREENS]5Legacy NDC20250509_38a31de8-3539-4af5-8bcc-176da188a2ac.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0478-0600363047806177 mL in 1 BOTTLE, PLASTIC (0363-0478-06) 177 ml2015-08-310000-00-00NoNoCurrent