FDA.reportPublic FDA data

Extra Strength TYLENOL Cold Plus Flu Multi-Action

Product NDC
50580-344
11-digit product format
505800344
Labeler code
50580
Product ID
50580-344_21702ebc-459b-7f5a-e063-6294a90ad432
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, Pseudoephedrine hydrochloride, and Dextromethorphan Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-21
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
500; 15; 30 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Extra Strength TYLENOL Cold Plus Flu Multi-Action
Brand name suffix
Day
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE500 mg/1
ACETAMINOPHEN15 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 362O9ITL9D, 6V9V2RYJ8N
Rxcui1250743

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-344-01Extra Strength TYLENOL Cold Plus Flu Multi-ActionDay12 in 1 BLISTER PACKTABLET, FILM COATED128
50580-344-01Extra Strength TYLENOL Cold Plus Flu Multi-ActionDay2 in 1 CARTONTABLET, FILM COATED28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-344-01EA - Each50580-344bb42db4e-7a0c-40fb-ac80-ce52e5c2bac112021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-344EXTRA STRENGTH TYLENOL COLD PLUS FLU MULTI-ACTION DAY (ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]8Current NDC, Legacy NDC, 2 package rows20241109_7d3266dc-879a-4d28-b8ea-74d238c3020a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250743acetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral TabletPSN7d3266dc-879a-4d28-b8ea-74d238c3020a8
1250743acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral TabletSCD7d3266dc-879a-4d28-b8ea-74d238c3020a8
1250743APAP 500 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral TabletSY7d3266dc-879a-4d28-b8ea-74d238c3020a8
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
50580-344-01505800344012 BLISTER PACK in 1 CARTON (50580-344-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2021-06-210000-00-00NoNoCurrent