FDA.reportPublic FDA data

Sinus Congestion and Pain

Product NDC
41163-664
11-digit product format
411630664
Labeler code
41163
Product ID
41163-664_4f9dc1f8-cb74-45c8-b132-bd31a373322e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-07-26
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Sinus Congestion and Pain
Brand name suffix
Daytime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046378Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3fc270a-92fc-46d5-b187-44e875c3abb9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-664-08Sinus Congestion and PainDaytime12 in 1 BLISTER PACKTABLET, FILM COATED1215
41163-664-08Sinus Congestion and PainDaytime2 in 1 CARTONTABLET, FILM COATED215

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ESINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1USINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-664SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]14Current NDC, Legacy NDC, 2 package rows20250217_f3fc270a-92fc-46d5-b187-44e875c3abb9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 52 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLHy-Vee, Inc.446de381-6685-748d-e063-6394a90a1b732026-02-04Warnings, Adverse reactionsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED85aadc86-d979-41a1-849a-e2ccc90144292026-02-04WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Incfa8c154c-56c6-47de-8e43-9e012b4be95f2026-02-04WarningsExact identifier
application number: M012
Foster and Thrive Cherry Cough DropsMENTHOLMcKesson49eefa70-cef9-d7ec-e063-6294a90ac3212026-02-03WarningsExact identifier
application number: M012
Foster and Thrive Honey Lemon Cough DropsMENTHOLMcKesson49f13ee3-6bb3-e500-e063-6394a90a152d2026-02-03WarningsExact identifier
application number: M012
Daytime Cold and Flu Mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp63cb19d4-2306-4723-a95e-9d2d8b9eccd02026-02-03WarningsExact identifier
application number: M012
Foster and Thrive SF Honey Lemon Cough DropsMENTHOLMcKesson49f41c30-f806-44ba-e063-6394a90a5a672026-02-03WarningsExact identifier
application number: M012
Nighttime Cold and Flu Mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corpb9af8ab4-a7cb-4adf-9f6f-398c6bb7f8532026-02-03WarningsExact identifier
application number: M012
allergy reliefDIPHENHYDRAMINE HCLMeijer Distribution Inc7c2fc244-bfc5-4e3c-aa90-8bc3d067b64f2026-02-03WarningsExact identifier
application number: M012
Cold and Allergy DPSEUDOEPHEDRINE HCL, TRIPROLIDINE HCLWalgreen Company832ac849-7f4a-489a-a704-9d4388a75a712026-02-03WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc987f908b-7af7-4705-bfb4-c48d771c380d2026-02-03WarningsExact identifier
application number: M012
tussin dm nighttime maxDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHyVee Inc1f3fb451-84c9-432e-ac67-2694dd66c8152026-02-03WarningsExact identifier
application number: M012
Robafen DM CoughDEXTROMETHORPHAN HBR, GUAIFENESINMajor Pharmaceuticals7c9660b7-cb00-449b-b65f-aa42d8ce19422026-02-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company6b0d261f-fc27-4b34-88b1-cd3d727667602026-02-02WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINCardinal Health 110, LLC. DBA Leaderebfcb699-3369-4697-9841-44015b1c98082026-02-02WarningsExact identifier
application number: M012
Cherry Sore Throat LozengesBENZOCAINE, MENTHOLMeijer Distribution Inc.2f6de590-7cad-25d7-e054-00144ff8d46c2026-02-02WarningsExact identifier
application number: M012
Mixed Berry Sore Throat and Cough lozengeDEXTROMETHORPHAN HYDROBROMIDEMeijer Distribution, Inc.304ff4db-201a-60a4-e054-00144ff8d46c2026-02-02WarningsExact identifier
application number: M012
Allergy Relief Plus CongestionDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company38d91107-d95c-40f2-a27e-561f951e519d2026-02-02WarningsExact identifier
application number: M012
Tussin SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHyVee Inc85252999-3463-45fe-b4a9-7a97960b41b12026-02-02WarningsExact identifier
application number: M012
Amazon Basics Cherry Cough Drops 30ctMENTHOLAmazon3e74e209-c9c9-3979-e063-6294a90afcfa2026-02-01WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNf3fc270a-92fc-46d5-b187-44e875c3abb915
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf3fc270a-92fc-46d5-b187-44e875c3abb915
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYf3fc270a-92fc-46d5-b187-44e875c3abb915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-664-08411630664082 BLISTER PACK in 1 CARTON (41163-664-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-07-260000-00-00NoNoCurrent