FDA.reportPublic FDA data

Tylenol Sinus Severe, CVP HEALTH

Product NDC
66715-6557
11-digit product format
667156557
Labeler code
66715
Product ID
66715-6557_459f7dbe-5021-08d1-e063-6294a90a8924
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Lil Drug Store Products, Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-06
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
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
Tylenol Sinus Severe, CVP HEALTH
Listing expiration
2026-12-31

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
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup
362O9ITL9DInternal 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
88b68447-b016-4d5b-a5e3-c4ebccb14f8cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6557-2Tylenol Sinus Severe, CVP HEALTH2 in 1 POUCHTABLET, COATED210
66715-6557-2Tylenol Sinus Severe, CVP HEALTH2 in 1 CARTONTABLET, COATED210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6557TYLENOL SINUS SEVERE, CVP HEALTH (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED LIL DRUG STORE TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED TYLENOL SINUS SEVERE, TRAVEL BASIX (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED TYLENOL SINUS SEVERE, LIL DRUG STORE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [LIL DRUG STORE PRODUCTS, INC]9Current NDC, 2 package rows20240725_88b68447-b016-4d5b-a5e3-c4ebccb14f8c.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 35 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)047102c4-3d03-4b2d-961d-0ac75980147b2026-05-06WarningsExact identifier
application number: M012
GOOD SENSE COMBO PACK DAYTIME AND NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Companyd25f2649-4f8a-4339-8443-faa0b98bdd702026-05-06WarningsExact identifier
application number: M012
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEWinCo Foods, LLC27e911e1-6d22-4a50-8413-1809c8973cbd2026-05-06WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Cough Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51173330-d537-fb9c-e063-6394a90ae3422026-05-05WarningsExact identifier
application number: M012
Equate daytime severe vaporice cold and flu nighttime severe vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEWal-Mart Stores Inc08e74a8d-8e8d-4cda-9adc-ea2ff40683532026-05-05WarningsExact identifier
application number: M012
GOODSENSE COMBO PACK DAYTIME AND NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLL. Perrigo Companye42f9e0d-f990-4c33-af43-75acf5d776382026-05-05WarningsExact identifier
application number: M012
Rugby Mucus and Chest Congestion 541GUAIFENESINRugby Laboratories76472912-b66f-4bb4-937a-4a589683a78c2026-05-04WarningsExact identifier
application number: M012
Sinus Congestion and Pain Daytime Non-DrowsyACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEH E Be9dd2d7b-0a19-4a42-b51e-b9914f02406e2026-05-04WarningsExact identifier
application number: M012
Sanatos NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC3dd3ed85-0c0a-8390-e063-6294a90a668e2026-05-04WarningsExact identifier
application number: M012
Good Sense Daytime non drowsy cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company0122cd34-5817-4af5-a51a-8d176dee0a302026-05-04WarningsExact identifier
application number: M012
COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafewayd810a6a9-6112-4e9d-a396-36084b7e110e2026-05-04WarningsExact identifier
application number: M012
Benadryl Allergy UltratabDIPHENHYDRAMINE HYDROCHLORIDESavings Distributors LLC8d59d121-62a8-c43b-e053-2a95a90a58472026-05-01WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESavings Distributors LLC8e87f8de-f83e-0f8d-e053-2a95a90a8d6a2026-05-01WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESavings Distributors LLC8eecb3f0-eb5e-e847-e053-2995a90a86bd2026-05-01WarningsExact identifier
application number: M012
Sinus Pressure and Congestion Relief PE Maximum StrengthPHENYLEPHRINE HCLRite Aid Corporationfccea3c5-42af-4939-82bc-d9409b75f91f2026-05-01WarningsExact identifier
application number: M012
Night Time Cold and Flu originalACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHarris Teeter, LLCcfaf4b3d-fab4-424d-adbe-aaedca58912d2026-04-30WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHarris Teeter, LLC21e7d323-5b78-43aa-b0fc-34c2a864ab9a2026-04-30WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLH E Bec0b5f4b-b58c-445f-acf1-c7ce301bba642026-04-30WarningsExact identifier
application number: M012
Mucus Relief DM Max Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINHarris Teeter, LLC098428ae-e87d-4c29-8f02-1590530da58e2026-04-29WarningsExact identifier
application number: M012
Panadol Cold and Flu DayACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC341761b9-f0be-f816-e063-6394a90a5e632026-04-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN88b68447-b016-4d5b-a5e3-c4ebccb14f8c10
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD88b68447-b016-4d5b-a5e3-c4ebccb14f8c10
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY88b68447-b016-4d5b-a5e3-c4ebccb14f8c10
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY88b68447-b016-4d5b-a5e3-c4ebccb14f8c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66715-6557-2667156557022 POUCH in 1 CARTON (66715-6557-2) / 2 TABLET, COATED in 1 POUCH2 pouch2022-05-06NoNoCurrent