NDC 73097-011

Tylenol Cold Plus Flu Severe

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

Tylenol Cold Plus Flu Severe is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Savings Distributors Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID73097-011_8e87e154-d823-c3c6-e053-2995a90a64fc
NDC73097-011
Product TypeHuman Otc Drug
Proprietary NameTylenol Cold Plus Flu Severe
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-07-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameSavings Distributors LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 73097-011-02

2 TABLET, FILM COATED in 1 POUCH (73097-011-02)
Marketing Start Date2019-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 73097-011-50 [73097001150]

Tylenol Cold Plus Flu Severe TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-15

NDC 73097-011-02 [73097001102]

Tylenol Cold Plus Flu Severe TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-15

NDC 73097-011-40 [73097001140]

Tylenol Cold Plus Flu Severe TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-15

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:8e87f8de-f83e-0f8d-e053-2a95a90a8d6a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1110988
  • NDC Crossover Matching brand name "Tylenol Cold Plus Flu Severe" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    29485-8056TYLENOL COLD PLUS FLU SEVEREAcetaminophen, Dextromethorphan HBr,Phenylephrine HCl, Guaifenesin
    29485-8058TYLENOL COLD PLUS FLU SEVEREAcetaminophen, Dextromethorphan HBr,Phenylephrine HCl, Guaifenesin
    29485-8060TYLENOL COLD PLUS FLU SEVEREAcetaminophen, Dextromethorphan HBr,Phenylephrine HCl, Guaifenesin
    29485-8062TYLENOL COLD PLUS FLU SEVEREAcetaminophen, Dextromethorphan HBr,Phenylephrine HCl, Guaifenesin
    50580-402TYLENOL Cold Plus Flu SevereTYLENOL Cold Plus Flu Severe
    50580-403TYLENOL COLD PLUS FLU SEVERETYLENOL COLD PLUS FLU SEVERE
    50269-402Tylenol Cold Plus Flu SevereTylenol Cold Plus Flu Severe
    73097-011Tylenol Cold Plus Flu SevereTylenol Cold Plus Flu Severe
    0280-0061Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermaxacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    0280-0507Alka-Seltzer Plus Severe Sinus Cold and CoughAcetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
    0113-7902basic care daytime cold and fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    0363-4661Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    0363-9974Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    41520-984COLD FLU and SORE THROAT RELIEFacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    41250-327Cold, Flu, and Sore Throatacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    41250-569daytime cold and fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    37808-796daytime severeacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    24385-066good neighbor pharmacy coldAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    0113-4500good sense sever day time cold and fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    47682-006Green Guard Cough and Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
    11822-1576Maximum Strength Severe Sinus Pressure, Pain and Cough ReliefAcetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride
    0031-8751Robitussin Severe Multi-Symptom Cough Cold Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    0363-1940severe cold and fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    0363-4150Severe Cold and Flu ReliefAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    41520-985Severe sinus Congestion Reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    11822-0940severe vapor ice cold and flu reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    21130-811signature care daytime severe cold and flu reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    36800-581topcare day time cold and fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    36800-948topcare day time cold and fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    36800-747Topcare Mucus Reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    36800-842topcare mucus relief cold and fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    0363-6300Walgreen Severe Multi-Symptom Cough Cold Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

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