NDC 50580-525

TYLENOL COLD MAX DAY

Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

TYLENOL COLD MAX DAY is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID50580-525_c004edeb-3516-4645-b67e-d0129a055514
NDC50580-525
Product TypeHuman Otc Drug
Proprietary NameTYLENOL COLD MAX DAY
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-05-25
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/15mL; mg/15mL; mg/15mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50580-525-01

240 mL in 1 BOTTLE, PLASTIC (50580-525-01)
Marketing Start Date2015-05-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50580-525-01 [50580052501]

TYLENOL COLD MAX DAY SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2015-05-25
Marketing End Date2018-09-30

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/15mL

OpenFDA Data

SPL SET ID:dc6798a6-aacf-47e8-8132-c5c3a7ea3a4e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1113705

    • NDC Crossover Matching brand name "TYLENOL COLD MAX DAY" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    50580-525TYLENOL COLD MAX DAYTYLENOL COLD MAX DAY
    50580-515TYLENOL Cold Max DayTYLENOL Cold Max Day
    36800-521Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    36800-921Cold Max DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    36800-514Cold plus Head CongestionACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    36800-924Cold Plus Head Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    41250-138COLD RELIEF MULTI-SYMPTOM DAYTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    33992-0611DaytimeAcetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
    0363-8998Daytime Non-Drowsy Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    37808-539HEB DayTime Flu And Severe Cold And CoughAcetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
    30142-112Kroger DayTime Flu plus Severe Cold and CoughAcetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
    0363-5556Maximum Strength Congestion and HeadacheAcetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
    0363-9019Maximum Strength Congestion and HeadacheAcetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
    33992-6110Multi Symptom DaytimeAcetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
    30142-768Non Drowsy Daytime Cold and Flu Softgelacetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride
    41163-172Pressure and Pain PE plus CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    36800-772Pressure Plus Pain PE Plus CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    11822-2112Rite Aid Daytime Severe Cold and Cough ReliefAcetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
    0031-8721ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    41190-112ShopRite DayTime Flu Plus Severe Cold And CoughAcetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
    29485-2827Vicks DayQuilAcetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
    37000-555Vicks DayQuilAcetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
    37000-558Vicks DayQuilAcetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
    37000-539VIcks Flu Therapyacetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride
    0363-1166Walgreens Daytime Non-Drowsy Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    0363-1167Walgreens Daytime Non-Drowsy Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE

    Trademark Results [TYLENOL COLD MAX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TYLENOL COLD MAX
    TYLENOL COLD MAX
    86144356 5018281 Live/Registered
    Johnson & Johnson
    2013-12-16
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.