FDA.reportPublic FDA data

Severe Sinus Pain and Congestion

Product NDC
59779-275
11-digit product format
597790275
Labeler code
59779
Product ID
59779-275_8505a29b-8fe3-49eb-870c-f076b4c4826f
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, guaifenesin, phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-08-06
Marketing end
2028-04-30
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
Severe Sinus Pain and Congestion
Brand name suffix
Daytime

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
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-275-08Severe Sinus Pain and CongestionDaytime2 in 1 CARTONTABLET, FILM COATED215
59779-275-08Severe Sinus Pain and CongestionDaytime12 in 1 BLISTER PACKTABLET, FILM COATED1215

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-275-08EA - Each59779-275ef56c562-5764-4932-ab6a-0bb0681ac4ac12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
GUAIFENESINACTIVE INGREDIENT495W7451VQSEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
GUAIFENESINACTIVE MOIETY495W7451VQSEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ESEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
TALCINACTIVE INGREDIENT7SEV7J4R1USEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-275SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]14Current NDC, Legacy NDC, 2 package rows20250105_4af347ce-9745-4a5e-8ce9-e7c97a0a6cc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN4af347ce-9745-4a5e-8ce9-e7c97a0a6cc715
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD4af347ce-9745-4a5e-8ce9-e7c97a0a6cc715
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY4af347ce-9745-4a5e-8ce9-e7c97a0a6cc715
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY4af347ce-9745-4a5e-8ce9-e7c97a0a6cc715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-275-08597790275082 BLISTER PACK in 1 CARTON (59779-275-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-08-062028-04-30NoNoCurrent