FDA.reportPublic FDA data

Extra Strength TYLENOL Cold plus Flu Multi-Action

Product NDC
50580-374
11-digit product format
505800374
Labeler code
50580
Product ID
50580-374_21719087-b7ff-e583-e063-6394a90aa10c
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate
Dosage form
KIT
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-21
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 Cold plus Flu Multi-Action
Brand name suffix
Day/Night
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1089968Internal RxNorm lookup
1250743Internal RxNorm lookup
2558505Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
712ba011-79aa-469b-9f0f-04a0b4b705bdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-374-012024-02-01C16284748780-11030e365-2581-111a-e063-dadaa90a10e2Extra Strength TYLENOL Cold + Flu Multi-Action Day/Night
50580-374-012024-01-30C16284748780-11030e365-2581-111a-e063-dadaa90a10e2Extra Strength TYLENOL Cold + Flu Multi-Action Day/Night

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-374-01Extra Strength TYLENOL Cold plus Flu Multi-ActionDay/Night1 in 1 PACKAGEKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-374-01EA - Each50580-374732d8ad1-1c35-4419-ad5b-8cc198bccd6412021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-374EXTRA STRENGTH TYLENOL COLD PLUS FLU MULTI-ACTION DAY/NIGHT (ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATE) KIT [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 1 package rows20241109_712ba011-79aa-469b-9f0f-04a0b4b705bd.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 126 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens TussnexACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company19e9678d-ac34-4af8-a80f-d08fce0a5f0e2024-12-19WarningsExact identifier
application number: M012
Vaporising Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILNew Pride Corpf66476d5-036b-0b1c-e053-2a95a90a0a072024-12-19WarningsExact identifier
application number: M012
Chest Rub Vaporizing ActionMENTHOL AND CAMPHOR AND EUCALYPTUS OILSinghfam Corporationc6ea663a-9c4f-4d1a-a937-002806a8530a2024-12-19WarningsExact identifier
application number: M012
ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTIONCAMPHOR (SYNTHETIC), LEVOMENTHOL, EUCALYPTUSSinghfam Corporationf1e4caee-b50e-a0a6-e053-2a95a90aadce2024-12-19WarningsExact identifier
application number: M012
Leader Vapor Steam camphor (synthetic)CAMPHOR (SYNTHETIC)LEADER/Cardinal Health 110, Inc.ae580e6c-2efd-c788-e053-2995a90a33602024-12-19WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINStrategic Sourcing Service, LLC0b6689db-ea34-9a06-e063-6394a90abaf72024-12-19WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILJell Pharmaceuticals Pvt Ltd.d80b9cc1-55f5-76d5-e053-2995a90aa9672024-12-19WarningsExact identifier
application number: M012
Health Smart Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUS OILHome Smart Productsacab200e-48bd-69e1-e053-2995a90afde02024-12-19WarningsExact identifier
application number: M012
Halls MENTHO-LYPTUSMENTHOLMondelez Global LLCff21cf0e-9811-4819-bdfc-17a950e9b1142024-12-19WarningsExact identifier
application number: M012
Tussnex FM Cold, Flu and Sore ThroatACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company7bddce11-c227-4d95-94c1-6f41ecd7285b2024-12-19WarningsExact identifier
application number: M012
Childrens Tussnex Multi-symptom coldDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company9028676e-d725-4afe-aa14-72235825aa172024-12-19WarningsExact identifier
application number: M012
Tussnex FM Cold and SinusACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company04c6bb6a-d2f8-4322-afba-e240e80901762024-12-19WarningsExact identifier
application number: M012
Tussnex FM Severe cough and congestionDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company387df403-7803-4031-915e-8de9b103a1622024-12-19WarningsExact identifier
application number: M012
Maximum strength Tussnex FM DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINGuardian Drug Company0bae53e3-9661-4bc6-9fcc-da7fa131b0342024-12-19WarningsExact identifier
application number: M012
Vicks Vaposteam LavenderCAMPHOR, (-)-Kaz USA, Inc03bf6b78-cf8e-44c6-bae0-5bd0a85f8aa92024-12-19WarningsExact identifier
application number: M012
Refenesen Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINReese Pharmaceutical Co6046dc50-f162-4e2d-aa3c-7d27efad477d2024-12-18WarningsExact identifier
application number: M012
Sunmark Chest Congestion Relief PE PEGUAIFENESIN/PHENYLEPHRINEStrategic Sourcing Services LLCf94ae469-4c79-4ce9-9a3d-3bdc645be6d92024-12-18WarningsExact identifier
application number: M012
Quality Choice Mucus Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINChain Drug Marketing Association1c33a01f-1186-4a19-b639-a9cd492452202024-12-18WarningsExact identifier
application number: M012
HealthMart Chest Congestion ReliefGUAIFENESINStrategic Sourcing Services LLCa5d1a8e8-10ba-4fff-b6f7-18c0fde5155c2024-12-18WarningsExact identifier
application number: M012
DG Health Immediate Release Mucus ReliefGUAIFENESINReese Pharmaceutical Cof60a9d1b-7a63-43d3-b843-e1f31cf788732024-12-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2558505{1 (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) / 1 (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) } PackGPCK712ba011-79aa-469b-9f0f-04a0b4b705bd6
25585051 daytime (acetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet) PackPSN712ba011-79aa-469b-9f0f-04a0b4b705bd6
1089968acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral TabletPSN712ba011-79aa-469b-9f0f-04a0b4b705bd6
1250743acetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral TabletPSN712ba011-79aa-469b-9f0f-04a0b4b705bd6
1089968acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral TabletSCD712ba011-79aa-469b-9f0f-04a0b4b705bd6
1250743acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral TabletSCD712ba011-79aa-469b-9f0f-04a0b4b705bd6
25585051 daytime (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) PackSY712ba011-79aa-469b-9f0f-04a0b4b705bd6
1089968APAP 500 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral TabletSY712ba011-79aa-469b-9f0f-04a0b4b705bd6
1250743APAP 500 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral TabletSY712ba011-79aa-469b-9f0f-04a0b4b705bd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-374-01505800374011 KIT in 1 PACKAGE (50580-374-01) * 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK1 kit2021-06-210000-00-00NoNoCurrent