FDA.reportPublic FDA data

Extra Strength TYLENOL Severe Cough Plus Sore Throat Night

Product NDC
50580-243
11-digit product format
505800243
Labeler code
50580
Product ID
50580-243_21d5b551-6600-0381-e063-6294a90a2985
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate.
Dosage form
LIQUID
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-19
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
1000; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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
Extra Strength TYLENOL Severe Cough Plus Sore Throat Night
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN1000 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1042684Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f81d924e-10e9-0e9d-e053-6294a90a2ddfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-243-01Extra Strength TYLENOL Severe Cough Plus Sore Throat Night240 mL in 1 BOTTLELIQUID2404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-243EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE.) LIQUID [KENVUE BRANDS LLC]4Current NDC, 1 package rows20241109_f81d924e-10e9-0e9d-e053-6294a90a2ddf.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 112 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATEDLil' Drug Store Products, Inc.37c55543-e05e-2f7c-e063-6394a90a45342025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Honey Lemon Sugar-FreeMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.38049d29-f47e-9478-e063-6294a90aa2a42025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Menthol Sugar FreeMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.3804a271-9a11-848d-e063-6394a90af87d2025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Menthol Sugar FreeMENTHOLArmy & Air Force Exchange Service3805ef07-247d-0df7-e063-6394a90ac45b2025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drop Black Cherry Sugar FreeMENTHOLArmy & Air Force Exchange Service3805f8f5-562f-0ba8-e063-6394a90ac9d92025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Honey Lemon Sugar-FreeMENTHOLArmy & Air Force Exchange Service3805f90e-bd89-128d-e063-6394a90afa012025-06-20WarningsExact identifier
application number: M012
TARGET Multi Symptom Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTARGET CORPORATIONaebe3c15-53ef-46ea-af39-8c9b8114595f2025-06-20WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMorning Star OTCbe95332d-a2e0-42e8-bfb3-8850d74990ff2025-06-19WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMorning Star OTC37e939c6-064b-3548-e063-6294a90a337d2025-06-19WarningsExact identifier
application number: M012
Capron DMDEXTROMETHORPHAN HBR AND PYRILAMINE MALEATECapital Pharmaceutical, LLCcf778c5f-475e-4a86-a87c-2be1e665f5a52025-06-18WarningsExact identifier
application number: M012
Cough OutGUAIFENESINEfficient Laboratories Inc.fe4c3921-8d30-4cd6-ba90-9211b362a38a2025-06-18WarningsExact identifier
application number: M012
Guaifenesin STRAWBERRY-BANANA FLAVORGUAIFENESINInnovida Pharmaeutique Corporation1006906e-d6d7-4f49-92bf-3cb2d2cdbb162025-06-18WarningsExact identifier
application number: M012
Mucinex Sinus Max Clear and CoolACETAMINOPHEN AND GUAIFENESINRB Health (US) LLC37de813a-54b7-672a-e063-6294a90a374e2025-06-18WarningsExact identifier
application number: M012
childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4a1aeb41-a8fa-4116-8068-e11acd608e582025-06-18WarningsExact identifier
application number: M012
NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIXACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATEDLil' Drug Store Products, Inc.37c768f5-dabd-22d0-e063-6394a90af9e52025-06-17WarningsExact identifier
application number: M012
DISCOUNT DRUG MART Childrens Allergy ChewableDIPHENHYDRAMINE HCLDISCOUNT DRUG MART51de95da-e8e8-48f0-9fa4-6191aa4a247b2025-06-16WarningsExact identifier
application number: M012
Halls CherryMENTHOLMondelez Global LLC5f4af8e8-8550-45c7-a199-694efac9e7be2025-06-16WarningsExact identifier
application number: M012
Halls Honey LemonMENTHOLMondelez Global LLC25eaae85-d516-40da-a472-70736ea2b75d2025-06-16WarningsExact identifier
application number: M012
Halls CherryMENTHOLMondelez Global LLCbad89968-22a7-4287-a57c-9e6206e574fe2025-06-16WarningsExact identifier
application number: M012
Herbal Throat DropsLEMON MINT HERBALMeijer, Inc.37dd58ad-95d1-568c-e063-6394a90a94332025-06-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1042684acetaminophen 500 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG in 15 mL Oral SolutionPSNf81d924e-10e9-0e9d-e053-6294a90a2ddf4
1042684acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDf81d924e-10e9-0e9d-e053-6294a90a2ddf4
1042684acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYf81d924e-10e9-0e9d-e053-6294a90a2ddf4
1042684acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYf81d924e-10e9-0e9d-e053-6294a90a2ddf4
1042684APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYf81d924e-10e9-0e9d-e053-6294a90a2ddf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50580-243-0150580024301240 mL in 1 BOTTLE (50580-243-01) 240 ml2023-06-19NoNoCurrent