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 46 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime and NighttimeACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS HEALTH CORP43da4211-3bb3-0a8e-e063-6294a90a4fcd2026-03-16WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Inc96d8b6d1-8a51-41a4-80d3-fab61492b3cc2026-03-14WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN,PHENYLEPHRINE HYDROCHLORIDECVS Pharmacy, Incc0b36e4d-3667-58f6-e053-2a95a90afad72026-03-14WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHyVee Inca16a85c2-e1fd-4d1a-a650-271ae430eb4f2026-03-14WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLKroger Companyab12c975-2085-4365-9c4b-0be573a260c42026-03-13WarningsExact identifier
application number: M012
Daytime Cold and Flu Non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)db0f0164-3cbd-49b0-91ef-2e5218b09c3f2026-03-12WarningsExact identifier
application number: M012
Allergy Relief CompleteDIPHENHYDRAMINE HCLWinCo Foods, LLC88e3e51a-c9a5-43f9-b9d7-97509c607df12026-03-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Kickstart Severe Cold and Flu and Mucinex Fast-Max Recharge Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, AND TRIPROLIDINE HCLRB Health (US) LLC4cc490a6-a27a-a25b-e063-6294a90a3a952026-03-11WarningsExact identifier
application number: M012
Mucus Relief Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLC6207ef50-4f28-4dbc-9a52-f44dd53d2a4f2026-03-11WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc17a10a3-6b8f-4734-8f00-1f4c5c7297252026-03-11WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLStrategic Sourcing Services LLCba6d69ff-b392-4f21-b3d7-00d8ec5dee322026-03-11WarningsExact identifier
application number: M012
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDESportpharm LLC67428f4b-28be-4682-a9a9-781bf85089ff2026-03-10WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHEB40091b98-b4c7-4a3b-e063-6294a90abd5d2026-03-10WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEUnited Natural Foods, Inc. dba UNFI0aa4ac07-bd02-46b2-9cf0-0643e0e1a2da2026-03-10WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATETopco Associates, LLC35305aa9-4fc1-4cda-b6f0-89df64f9eeff2026-03-10WarningsExact identifier
application number: M012
nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafeway03332596-2c37-4771-b13b-ab766e6168662026-03-10WarningsExact identifier
application number: M012
Sinus Pressure and Congestion Relief Maximum StrengthPSEUDOEPHEDRINE HCLRite Aid Corporationd86140ab-1117-4d14-a380-f5cc375775a12026-03-10WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLAMERISOURCE BERGEN4c9cca86-41bf-1635-e063-6294a90a17fb2026-03-09WarningsExact identifier
application number: M012
sinus pressure and pain and coughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTarget Corporation488588f3-62d3-4248-937a-1c200792b5f12026-03-09WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEGrocery Outlet, Inc.447a8753-96bd-676a-e063-6394a90a48f22026-03-06WarningsExact 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