NDC 67751-177

Handy Solutions Cold Relief

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

Handy Solutions Cold Relief is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Navajo Manufacturing Company Inc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID67751-177_77f62401-fd95-e92e-e053-2a91aa0a2b21
NDC67751-177
Product TypeHuman Otc Drug
Proprietary NameHandy Solutions Cold Relief
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-10-22
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameNavajo Manufacturing Company Inc.
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 67751-177-03

2 TABLET in 1 POUCH (67751-177-03)
Marketing Start Date2016-10-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67751-177-01 [67751017701]

Handy Solutions Cold Relief TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-22
Marketing End Date2018-10-12

NDC 67751-177-02 [67751017702]

Handy Solutions Cold Relief TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-22
Marketing End Date2018-10-12

NDC 67751-177-04 [67751017704]

Handy Solutions Cold Relief TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-22

NDC 67751-177-03 [67751017703]

Handy Solutions Cold Relief TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-22

NDC 67751-177-05 [67751017705]

Handy Solutions Cold Relief TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-22

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:affddef4-c724-4bf6-8608-6eeffa38d684
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1367204
  • NDC Crossover Matching brand name "Handy Solutions Cold Relief" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    67751-177Handy Solutions Cold ReliefHandy Solutions Cold Relief
    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
    47682-138Medique Decorel Forte PlusACETAMINOPHEN, 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.