FDA.reportPublic FDA data

Sinus Congestion and Pain Relief

Product NDC
67091-213
11-digit product format
670910213
Labeler code
67091
Product ID
67091-213_315637af-ce17-4b8b-b9ed-2c4698edffeb
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
WinCo Foods, LLC
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
2026-12-31
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 Relief
Brand name suffix
Non-Drowsy
Listing expiration
2026-12-31

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
f7e925f4-7da6-4157-a97f-e6a3e399911fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-213-24Sinus Congestion and Pain ReliefNon-Drowsy12 in 1 BLISTER PACKTABLET, FILM COATED1214
67091-213-24Sinus Congestion and Pain ReliefNon-Drowsy2 in 1 CARTONTABLET, FILM COATED214

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4SINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1USINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-213SINUS CONGESTION AND PAIN RELIEF NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WINCO FOODS, LLC]13Current NDC, Legacy NDC, 2 package rows20241218_f7e925f4-7da6-4157-a97f-e6a3e399911f.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 115 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling MentholOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33fe0e49-3de5-8afd-e063-6294a90a0ad52025-05-02WarningsExact identifier
application number: M012
Daytime and Nighttime High Blood Pressure Cold and Flu LiquidACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy, Inc.2d13964a-8cc4-f3dc-e063-6394a90aa1052025-05-02WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HCL 12.5 MG PER 5 MLDIPHENHYDRAMINE HCL 12.5 MG PER 5 MLAARNA USA INC.32c26835-f54e-d7e5-e063-6294a90ae1c02025-04-30WarningsExact identifier
application number: M012
SUDAFED OM Sinus Severe No Drip Nasal MistOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33e6239b-364a-0e62-e063-6294a90a50472025-04-29WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCVS Pharmacy8296049c-72fc-4200-9d45-c8e377314cf22025-04-29WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEAurohealth LLC70e1bd25-c32e-491f-b383-91d6f74957a02025-04-28WarningsExact identifier
application number: M012
Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HCLCVS Pharmacy70914691-220c-4fce-9ee1-61a51e8864bc2025-04-26WarningsExact identifier
application number: M012
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions810ce630-41be-4e15-b64a-d70f63abaf622025-04-24WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEH E B5f945975-224f-43eb-b129-a61e3b25c4bb2025-04-22WarningsExact identifier
application number: M012
Walgreens Severe Honey Lemon Throat DropsMENTHOLWalgreens334a9348-2a44-5c94-e063-6394a90ae9562025-04-21WarningsExact identifier
application number: M012
meijer Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bd85bc3-e600-583d-e063-6294a90a7be12025-04-18WarningsExact identifier
application number: M012
Daytime Nighttime Ultra ConcentratedDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKROGER COMPANY2be4a37b-44e1-8a8e-e063-6394a90a26a92025-04-17WarningsExact identifier
application number: M012
good neighbor pharmacy childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEAmerisource Bergencde0fd43-771f-4528-bad2-5727efec52502025-04-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC729ab412-f30b-4ad1-9d8f-1a5e1c48b1182025-04-16WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.9382c976-3067-4923-a38f-101d1c481e972025-04-11WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HCL LIQUID FILLED CAPSULESWalmart Inc.263d31c8-bdc2-a289-e063-6394a90a4aaa2025-04-10WarningsExact identifier
application number: M012
CVS Wild Cherry Throat DropPECTINCVS31f4b641-e9c0-786e-e063-6394a90aa2532025-04-04WarningsExact identifier
application number: M012
Nighttime Ultra Concentrated Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELSWALGREENS2be0a699-e6ad-ef56-e063-6394a90aaca52025-04-03WarningsExact identifier
application number: M012
Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED44fb27d3-5125-4511-84d2-76555bc46e662025-04-03WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINKESIN PHARMA CORPORATION31b8ad0a-3637-03db-e063-6394a90acdc32025-04-01WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNf7e925f4-7da6-4157-a97f-e6a3e399911f14
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf7e925f4-7da6-4157-a97f-e6a3e399911f14
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYf7e925f4-7da6-4157-a97f-e6a3e399911f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-213-24670910213242 BLISTER PACK in 1 CARTON (67091-213-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-07-260000-00-00NoNoCurrent