FDA.reportPublic FDA data

Sinus Pressure, Pain and Cough

Product NDC
79481-6172
11-digit product format
794816172
Labeler code
79481
Product ID
79481-6172_7205de12-c743-4e0d-8cca-de0aa1c12d21
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Meijer Distribution, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-20
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [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 Pressure, Pain and Cough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal 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
1110988Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f701a6ae-200d-48dc-94e4-6bd3228f50d4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-6172-9Sinus Pressure, Pain and Cough2 in 1 CARTONTABLET, FILM COATED23
79481-6172-9Sinus Pressure, Pain and Cough10 in 1 BLISTER PACKTABLET, FILM COATED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-6172SINUS PRESSURE, PAIN AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION, INC.]2Current NDC, 2 package rows20241122_f701a6ae-200d-48dc-94e4-6bd3228f50d4.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 161 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Cold and Flu Relief Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIe4f9a846-ab72-4508-b0c5-f7911af2f3d72024-05-23WarningsExact identifier
application number: M012
Adult Cough ReliefDEXTROMETHORPHAN HBRQUALITY CHOICE (Chain Drug Marketing Association)6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c2024-05-20WarningsExact identifier
application number: M012
Chlorpheniramine Maleate 4 mgCHLORPHENIRAMINE MALEATEBryant Ranch Prepack54681242-c861-4415-b5c0-d3ab55b62be12024-05-17WarningsExact identifier
application number: M012
Dibromm Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)c830b18b-4427-4530-9bc7-85c2735080d22024-05-17WarningsExact identifier
application number: M012
Childrens Cold and Cough NighttimeDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLSafeway, Inc.cbbec807-f882-4c6a-b1cd-c7fd5ce70cad2024-05-15WarningsExact identifier
application number: M012
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.d6ac0d70-0511-4ec8-bb35-8b2e0e3d77422024-05-15WarningsExact identifier
application number: M012
Night Time CoughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.f658a03b-6fc2-4b63-b3ab-7e886fbf20b42024-05-15WarningsExact identifier
application number: M012
AXIV DM MaxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINVIVUNT PHARMA LLC18704e66-ee8f-315d-e063-6294a90a52822024-05-14WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLTarget Corporation Inc.187622dc-ecde-181d-e063-6294a90a4e8f2024-05-14WarningsExact identifier
application number: M012
Lemon Mint DropsMENTHOLTarget Corporation Inc.1876df19-398a-23d8-e063-6394a90ae7e82024-05-14WarningsExact identifier
application number: M012
Cold Flu and Sore Throat Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafeway, Inc.6c952c81-c8b6-4e74-abd8-781f6f44736b2024-05-14WarningsExact identifier
application number: M012
Pain and Sinus RelieverACETAMINOPHEN AND PHENYLEPHRINEJHK DBA American Safety & First Aid249373c6-f56f-4bd3-9cef-98b7ee73457d2024-05-14WarningsExact identifier
application number: M012
NasalPHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.fea71cb9-e044-4729-ad26-1db0cdb9dd112024-05-14WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.a70ead03-6d2c-44c1-9ae5-f6c4094821ec2024-05-14WarningsExact identifier
application number: M012
Day Time Cold and Flu Relief non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESafeway, Inc.cc450f89-a156-48e0-82ae-19782f13c2ca2024-05-13WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLSafeway, Inc.a8df5c04-0f92-4013-b3e5-2b45009a7b8d2024-05-13WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATESafeway, Inc.f762600a-f4b1-4869-a04b-8431c3d8a3e32024-05-13WarningsExact identifier
application number: M012
Cold and Flu DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESafeway, Inc.ef0cd436-5e81-47a7-92d6-58495283ab282024-05-13WarningsExact identifier
application number: M012
Tussin Cough Sugar FreeDEXTROMETHORPHAN HBR GUAIFENESINP & L Development, LLC7ed2fe86-3346-4308-a9b6-6a264f879b022024-05-09WarningsExact identifier
application number: M012
Severe Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANY10106c90-f2f0-508e-e063-6294a90a544b2024-05-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSNf701a6ae-200d-48dc-94e4-6bd3228f50d43
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf701a6ae-200d-48dc-94e4-6bd3228f50d43
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSYf701a6ae-200d-48dc-94e4-6bd3228f50d43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-6172-9794816172092 BLISTER PACK in 1 CARTON (79481-6172-9) / 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2024-11-20NoNoCurrent