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 117 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY, INC1b8d5494-1fcf-4cd0-acc0-34f17d577bd72025-03-14WarningsExact identifier
application number: M012
Ultra Concentrated Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300b2357-933b-fe9a-e063-6294a90aa4b92025-03-11WarningsExact identifier
application number: M012
Ultra Concentrated Nighttime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEPuraCap Pharmaceutical LLC300bf27f-744f-7366-e063-6394a90acbcb2025-03-11WarningsExact identifier
application number: M012
Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300c7c7b-ea0b-3650-e063-6294a90a65e82025-03-11WarningsExact identifier
application number: M012
Rompe Pecho NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLEFFICIENT LABORATORIES INC2ec319a8-92bf-4552-86dd-37cbce18980f2025-03-11WarningsExact identifier
application number: M012
HISTEX-DM New FormulationDEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCIAllegis Pharmaceuticals, LLC30010401-e5b4-2bd9-e063-6394a90a0b0b2025-03-10WarningsExact identifier
application number: M012
daytime severe cold multi-symptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcc7c5f1c-76b7-4278-8e2a-5fbc85e022dd2025-03-08WarningsExact identifier
application number: M012
Cold and Head Congestion Relief SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWinCo Foods, LLCa39778ba-1f63-4495-8e9b-44b0bdd7f71a2025-03-08WarningsExact identifier
application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat DayACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC2e9540e4-bd1d-9370-e063-6294a90affcb2025-03-07WarningsExact identifier
application number: M012
Herbal Cough Drops Original HerbCOUGH DROPSTopco Associates LLC2fb22181-aee3-d0bf-e063-6294a90a78652025-03-06WarningsExact identifier
application number: M012
REVASOL DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERnv LLC2f9ddcc3-b913-f8b0-e063-6294a90a93ab2025-03-05WarningsExact identifier
application number: M012
Herbal Throat Drops Lemon Mint HerbTHROAT DROPSTopco Associates LLC2fa086b4-3b0e-0df8-e063-6294a90a67692025-03-05WarningsExact identifier
application number: M012
Redicare Nasal and Sinus DecongestantREDICARE NASAL AND SINUS DECONGESTANTRedicare LLC2f24be68-f30e-d916-e063-6294a90a7e312025-03-04WarningsExact identifier
application number: M012
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HCL ORAL SOLUTIONKesin Pharma Corporation2f871005-de4d-8b2a-e063-6394a90aa43a2025-03-04WarningsExact identifier
application number: M012
CVS Daytime Cough Relief Chews - Citrus PunchDEXTROMETHORPHAN HBRCVS2f885f1b-7ff5-251b-e063-6394a90a656f2025-03-04WarningsExact identifier
application number: M012
CVS Dex-Dox Kids Nighttime Cough SuppressantDEXTROMETHORPHAN HBRCVS2f8b6f5e-399c-b033-e063-6294a90ac3d12025-03-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCff8b096c-8f01-4a8c-a98f-e4aa4d688e952025-03-04WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Vanilla FlavorMENTHOL7-ELEVEN2f3c43dd-175f-722e-e063-6294a90acff92025-02-28WarningsExact identifier
application number: M012
Menthol Cough Drops Creamy Strawberry FlavorMENTHOL AND PECTIN7-ELEVEN2f3c3c65-4178-6304-e063-6294a90a51fa2025-02-28WarningsExact identifier
application number: M012
Menthol Cough Drops Creamy Strawberry FlavorMENTHOL AND PECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.2efbffd7-bbdd-c5f5-e063-6294a90a15f02025-02-25WarningsExact 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