FDA.reportPublic FDA data

Sinus Congestion and Pain

Product NDC
55301-527
Requested package NDC
55301-527-08
11-digit product format
553010527
Labeler code
55301
Product ID
55301-527_8816fa81-0cbf-4f8f-98fa-c20b7d103e85
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin and Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-08-06
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 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
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55301-52755301-527-08DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
GUAIFENESINACTIVE INGREDIENT495W7451VQSINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
GUAIFENESINACTIVE MOIETY495W7451VQSINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ESINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4SINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
TALCINACTIVE INGREDIENT7SEV7J4R1USINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSINUS CONGESTION AND PAIN SEVERE (ACEETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-527SINUS CONGESTION AND PAIN SEVERE (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]15Legacy NDC20241101_f90a183c-561b-42cf-bb97-558634dc5f71.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-527-08553010527082 BLISTER PACK in 1 CARTON (55301-527-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-08-060000-00-00NoNoCurrent