FDA.reportPublic FDA data

Tylenol Sinus Severe

Product NDC
50580-507
11-digit product format
505800507
Labeler code
50580
Product ID
50580-507_5e691fd8-3462-c044-e063-6294a90ad886
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Kenvue Brands 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
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41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-507-01Tylenol Sinus Severe12 in 1 BLISTER PACKTABLET, COATED1216
50580-507-01Tylenol Sinus Severe2 in 1 CARTONTABLET, COATED216
50580-507-02Tylenol Sinus Severe2 in 1 CARTONTABLET, COATED216
50580-507-02Tylenol Sinus Severe3 in 1 PACKAGETABLET, COATED316
50580-507-03Tylenol Sinus Severe2 in 1 POUCHTABLET, COATED216
50580-507-04Tylenol Sinus Severe50 in 1 CARTONTABLET, COATED5016
50580-507-04Tylenol Sinus Severe2 in 1 POUCHTABLET, COATED216

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-507-01EA - Each50580-507ee10d929-4cd2-4906-8663-c84fe7e61be412016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
GuaifenesinACTIVE INGREDIENT495W7451VQTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
AcetaminophenACTIVE MOIETY362O9ITL9DTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
GuaifenesinACTIVE MOIETY495W7451VQTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
PhenylephrineACTIVE MOIETY1WS297W6MVTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
hydroxypropyl cellulose (type e)INACTIVE INGREDIENT66O7AQV0RTTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
triacetinINACTIVE INGREDIENTXHX3C3X673TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-507TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [KENVUE BRANDS LLC]16Current NDC, Legacy NDC, 7 package rows20241103_7a60184f-91a9-4b85-b243-871deca63450.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 21 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWinCo Foods, LLC5f1aaa8e-c65f-43b3-9850-c60c1663d78f2026-06-22WarningsExact identifier
application number: M012
DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.e5a64d5a-c1ff-453d-b0c1-fe265b9e2c8a2026-06-22WarningsExact identifier
application number: M012
NO DRIP NASALPHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7a866cdf-1c0c-403a-afc8-0e99e0ce81aa2026-06-22WarningsExact identifier
application number: M012
Maximum Strength Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBRKROGER COMPANY30d4c4b9-0f5f-0279-e063-6394a90af1b52026-06-19WarningsExact identifier
application number: M012
GoodMeds Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECabinet Health P.B.C.6a8a961c-d2d2-428d-8af7-8527aae25c8a2026-06-19WarningsExact identifier
application number: M012
equaline nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI490766e7-1781-4b2b-a8f4-d4efb9fff5602026-06-19WarningsExact identifier
application number: M012
Equate NasalPHENYLEPHRINE HYDROCHLORIDEWALMART INC.30f6d588-ad80-4348-a45f-77337e067bca2026-06-19WarningsExact identifier
application number: M012
GUAIFENESINGUAIFENESINCardinal Health 107, LLC888b6a2e-6631-4585-a7fe-eb122eb51b232026-06-18WarningsExact identifier
application number: M012
Extra Strength TYLENOL Cold plus Flu Multi Symptom DayACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5487b2e1-b0e5-0236-e063-6394a90a3a8b2026-06-18WarningsExact identifier
application number: M012
Vaporizing Colds RubMENTHOLDelon Laboratories (1990) Ltd3ed8bc0c-c229-450b-a491-06b578c1b8ee2026-06-18WarningsExact identifier
application number: M012
Allergy ChildrensDIPHENHYDRAMINE HCLDOLGENCORP, LLC218c447e-9ddd-428a-9b33-0acec35e0d1b2026-06-17WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWALMART INC.a9d5f9f4-ddec-4ad6-ad06-4a612008bb682026-06-17WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Companye49d2a0f-6588-439b-8a46-c073e0bc4f9a2026-06-17WarningsExact identifier
application number: M012
COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafewayac0380ad-c9fa-4bda-ab84-c2e6aa672bdf2026-06-17WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC1a21cbb2-1ba5-414f-a31f-42b7a7bddae52026-06-16WarningsExact identifier
application number: M012
Tussin DM RegularDEXTROMETHORPHAN HBR AND GUAIFENESINAARNA USA, Inc.5460c809-71c8-3ad6-e063-6294a90a4e4f2026-06-16WarningsExact identifier
application number: M012
Equate Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.4b111580-cd20-43ec-9ff4-4b9f74f7d2e82026-06-16WarningsExact identifier
application number: M012
Sinus CongestionPHENYLEPHRINE HCLChain Drug Marketing Association, Inc.43a77f89-e66a-4db6-8067-f614c0e207df2026-06-16WarningsExact identifier
application number: M012
severe sinus congestion relief Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation51175d3e-e1c3-4e4d-ad32-61600e87568c2026-06-16WarningsExact identifier
application number: M012
foster and thrive daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLStrategic Sourcing Services LLC067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a62026-06-16WarningsExact 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 TabletPSN7a60184f-91a9-4b85-b243-871deca6345016
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD7a60184f-91a9-4b85-b243-871deca6345016
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY7a60184f-91a9-4b85-b243-871deca6345016
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY7a60184f-91a9-4b85-b243-871deca6345016
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN4bff8a41-ec6f-4bc5-a3df-2ea4695d9e246
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD4bff8a41-ec6f-4bc5-a3df-2ea4695d9e246
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY4bff8a41-ec6f-4bc5-a3df-2ea4695d9e246
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY4bff8a41-ec6f-4bc5-a3df-2ea4695d9e246
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN8eecb3f0-eb5e-e847-e053-2995a90a86bd3
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD8eecb3f0-eb5e-e847-e053-2995a90a86bd3
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY8eecb3f0-eb5e-e847-e053-2995a90a86bd3
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY8eecb3f0-eb5e-e847-e053-2995a90a86bd3
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN435b4a2a-d6bf-ec25-e063-6294a90a3f061
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN37e939c6-064b-3548-e063-6294a90a337d1
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN1560b3a0-fe81-4e33-b581-20b43511dba31
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD435b4a2a-d6bf-ec25-e063-6294a90a3f061
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD37e939c6-064b-3548-e063-6294a90a337d1
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1560b3a0-fe81-4e33-b581-20b43511dba31
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY435b4a2a-d6bf-ec25-e063-6294a90a3f061
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY37e939c6-064b-3548-e063-6294a90a337d1
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY1560b3a0-fe81-4e33-b581-20b43511dba31
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY435b4a2a-d6bf-ec25-e063-6294a90a3f061
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY37e939c6-064b-3548-e063-6294a90a337d1
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY1560b3a0-fe81-4e33-b581-20b43511dba31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-507-01505800507012 BLISTER PACK in 1 CARTON (50580-507-01) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2015-05-150000-00-00NoNoCurrent
50580-507-02505800507023 CARTON in 1 PACKAGE (50580-507-02) / 2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK3 carton2020-07-06NoNoCurrent
50580-507-03505800507032 TABLET, COATED in 1 POUCH (50580-507-03) 2017-07-170000-00-00NoNoCurrent
50580-507-045058005070450 POUCH in 1 CARTON (50580-507-04) / 2 TABLET, COATED in 1 POUCH50 pouch2017-07-170000-00-00NoNoCurrent
50580-507-72505800507723 CARTON in 1 CARTON (50580-507-72) / 1 BLISTER PACK in 1 CARTON / 24 TABLET, COATED in 1 BLISTER PACK3 carton2026-03-16NoNoCurrent