NDC 68210-0101

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE

Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Spirit Pharmaceuticals, Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID68210-0101_896b3914-8b53-4fcd-94d9-e84daf967cfe
NDC68210-0101
Product TypeHuman Otc Drug
Proprietary NameACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2009-10-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameSPIRIT PHARMACEUTICALS, LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68210-0101-3

1000 CAPSULE, LIQUID FILLED in 1 BOX (68210-0101-3)
Marketing Start Date2009-10-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68210-0101-4 [68210010104]

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-10-15
Inactivation Date2020-01-31

NDC 68210-0101-6 [68210010106]

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-09-08
Inactivation Date2020-01-31

NDC 68210-0101-5 [68210010105]

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-10-15
Inactivation Date2020-01-31

NDC 68210-0101-2 [68210010102]

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-10-15
Inactivation Date2020-01-31

NDC 68210-0101-1 [68210010101]

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-10-15
Inactivation Date2020-01-31

NDC 68210-0101-3 [68210010103]

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-10-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:17aebf77-55d8-4a02-8391-28bbd9c3b373
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1086997

    • NDC Crossover Matching brand name "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    68210-0101ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    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
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