FDA.reportPublic FDA data

Tylenol Sinus Severe

Product NDC
85237-1955
11-digit product format
852371955
Labeler code
85237
Product ID
85237-1955_52c5c1df-46bc-f82a-e063-6294a90af6f0
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Select Consumer Group LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-05-15
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
Tylenol Sinus Severe
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal 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
1243679Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
52c5fda0-c358-72e8-e063-6394a90a3f68Available on FDA.report

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 58 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mixed Berry Throat and Cough LozengesBENZOCAINECVS Pharmacy737b1c88-1a44-68cf-e053-2991aa0a35b62026-01-16WarningsExact identifier
application number: M012
Walgreens Wild Cherry Throat DropsPECTINWalgreens4885eca3-c1e9-8350-e063-6394a90ac2902026-01-16WarningsExact identifier
application number: M012
HBP Chest Congestion and Cough ReliefGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEWalgreensff7a1462-9994-4421-85aa-c03488bb04cf2026-01-16WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HBRWALGREEN COMPANYa793acbc-107c-4638-a2d7-65f4e96cafda2026-01-16WarningsExact identifier
application number: M012
MUCUS RELIEF DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEWalgreensca53ec26-d167-1780-e053-2a95a90a5b882026-01-16WarningsExact identifier
application number: M012
Maximum Strength Congestion and HeadacheACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens88da92d2-92c2-445a-9b70-58996e0860142026-01-16WarningsExact identifier
application number: M012
Maximum Strength Cold and FluACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens5f638bca-55c2-4ead-8c47-3f15713495da2026-01-16WarningsExact identifier
application number: M012
COLD, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens190175bb-c08a-4050-aacf-29a130cbe05c2026-01-16WarningsExact identifier
application number: M012
Night Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEFSA Store Inc. (Caring Mills)a9bd1efc-51c7-40d0-a4f8-f130ce5b45ff2026-01-16WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLL.N.K. International, Inc.99147338-f459-4423-ae54-f96fffc1728d2026-01-15WarningsExact identifier
application number: M012
SanaTos Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC144aafcc-6ec2-a322-e063-6294a90afc272026-01-15WarningsExact identifier
application number: M012
SanaTos Severe Cold and Cough DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC14484bf5-ff45-b859-e063-6394a90a9a0f2026-01-15WarningsExact identifier
application number: M012
Foster and Thrive Chest Congestion Relief PE PEGUAIFENESIN/PHENYLEPHRINEStrategic Sourcing Services LLC3429aedc-e83d-498a-bfca-03aaf5847b3b2026-01-15WarningsExact identifier
application number: M012
Quality Choice Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association4b86101c-00f8-4ede-807f-db4273b37b8d2026-01-15WarningsExact identifier
application number: M012
Quality Choice Mucus Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINChain Drug Marketing Associationd1ba7267-6844-4a14-b518-65277a32e8552026-01-15WarningsExact identifier
application number: M012
ACTINEL DM PediatricDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEACTIPHARMA, LLCf85d8586-423f-48a3-9bb2-bbc5984c7cd32026-01-15WarningsExact identifier
application number: M012
ACTINEL DiabeticDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINACTIPHARMA, LLC35c21623-84dd-4151-b35b-e7d30b69c9c02026-01-15WarningsExact identifier
application number: M012
Pocket FarmacyMENTHOLSaje Natural Business Inc.bdc15c6f-73b4-488e-9134-e70565df71bb2026-01-14WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HCL 50 MGDIPHENHYDRAMINE HCLYYBA Corporation4b012549-3958-43c1-9de7-897c5d8b20d32026-01-14WarningsExact identifier
application number: M012
Rite Aid Pharmacy congestion relief vaporizing steamVAPORIZING STEAMRite Aid Pharmacy0fb86b23-0313-8fd8-e063-6394a90a0f5f2026-01-14WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85237-1955-1852371955011 POUCH in 1 BLISTER PACK (85237-1955-1) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) 1 pouch2025-06-04NoNoCurrent
85237-1955-2852371955022 POUCH in 1 BLISTER PACK (85237-1955-2) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) 2 pouch2025-06-04NoNoCurrent
85237-1955-38523719550320 POUCH in 1 CARTON (85237-1955-3) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) 20 pouch2025-06-04NoNoCurrent
85237-1955-48523719550425 POUCH in 1 CARTON (85237-1955-4) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) 25 pouch2025-06-04NoNoCurrent
85237-1955-68523719550650 POUCH in 1 CARTON (85237-1955-6) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) 50 pouch2025-06-04NoNoCurrent
85237-1955-7852371955073 POUCH in 1 BLISTER PACK (85237-1955-7) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) 3 pouch2025-06-04NoNoCurrent