NDC 51013-197

cold, flu and sore throat

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

cold, flu and sore throat is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Puracap Pharmaceutical Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID51013-197_4593e2c5-f636-4ec6-9249-edc80d4e41d9
NDC51013-197
Product TypeHuman Otc Drug
Proprietary Namecold, flu and sore throat
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2017-07-12
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePuraCap Pharmaceutical LLC
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 51013-197-14

2 BLISTER PACK in 1 CARTON (51013-197-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2017-07-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51013-197-14 [51013019714]

cold, flu and sore throat CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-07-12

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:87e5e966-e680-4ae6-bb1d-3ed1603b76d6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1656815
  • NDC Crossover Matching brand name "cold, flu and sore throat" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    0363-1171COLD, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    0363-9016COLD, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    51013-197cold, flu and sore throatcold, flu and sore throat
    55316-013cold, flu and sore throatcold, flu and sore throat
    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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