NDC 51013-163

Daytime SEVERE COLD and FLU

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

Daytime SEVERE COLD and FLU 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 ID51013-163_20de9285-72b8-4007-9f13-7d5ea986c6ed
NDC51013-163
Product TypeHuman Otc Drug
Proprietary NameDaytime SEVERE COLD and FLU
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-07-20
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 Through2020-12-31

Packaging

NDC 51013-163-04

2 BLISTER PACK in 1 CARTON (51013-163-04) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2016-07-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51013-163-04 [51013016304]

Daytime SEVERE COLD and FLU CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-07-20

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:036f806e-f7e3-45bd-ae1b-b21f1682be74
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1656815
  • NDC Crossover Matching brand name "Daytime SEVERE COLD and FLU" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    30142-603daytime severe cold and fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    37808-178DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
    37808-603daytime severe cold and fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    41226-625DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN
    30142-548daytime severe cold and fludaytime severe cold and flu
    51013-163Daytime SEVERE COLD and FLUDaytime SEVERE COLD and FLU
    53345-021Daytime Severe Cold and FluDaytime Severe Cold and Flu
    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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