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 32 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC14c56f3d-67fd-45ef-a16b-f276047228832026-05-12WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare, LLC.51a4195b-8776-964c-e063-6294a90aa0752026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu and Mucinex Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3ba3548e-85e7-b4a6-e063-6394a90af84d2026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCfe7eeb71-e219-4c84-ac06-98c3a40b14dc2026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC6f8241d7-0f30-40b3-926b-861c57079f1d2026-05-12WarningsExact identifier
application number: M012
Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51a45db8-2bee-6fd0-e063-6394a90ab5872026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC19da539e-7b57-41d7-aad5-fc89a6705e202026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC182222b5-a852-4dbe-b05f-a41d898060212026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC8a790eeb-7d7d-4a94-9103-6ed09c04d5962026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCdbdafbb4-f3c9-4042-b867-db4d06dc3d612026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd03ef2fd-1a08-42c0-b69d-fd4e4285ccd32026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC29571047-4c4b-44ca-8726-57c28308e8cf2026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain and Mucinex Nightshift SinusACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC75c6b92f-219f-4740-bb72-c02a927a21ff2026-05-12WarningsExact identifier
application number: M012
Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCc746953f-4b7d-4e2a-9b85-96bd6901f5172026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCcea08797-1d53-4434-be1a-144f2ded5f9d2026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC2ef9d5de-e99e-4398-bf97-c7bef94498fa2026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCa401eb92-60b6-427d-a677-29371a3150be2026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCc902b4fc-c71c-4ef2-b5cb-6c2bd019acbc2026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC3ff4c4ea-7628-4d2b-a6e9-d994c25baef42026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd7c18e95-8d7b-4550-9a20-fc704a114adb2026-05-12WarningsExact 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