NDC 68210-0118

Assured Maximum Strength Nasal Decongestant

Phenylephrine Hcl

Assured Maximum Strength Nasal Decongestant is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Spirit Pharmaceuticals Llc. The primary component is Phenylephrine Hydrochloride.

Product ID68210-0118_82d6227b-18d3-b0cd-e053-2991aa0a2a77
NDC68210-0118
Product TypeHuman Otc Drug
Proprietary NameAssured Maximum Strength Nasal Decongestant
Generic NamePhenylephrine Hcl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-02-26
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameSpirit Pharmaceuticals LLC
Substance NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68210-0118-3

1 BLISTER PACK in 1 CARTON (68210-0118-3) > 24 TABLET in 1 BLISTER PACK
Marketing Start Date2019-02-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68210-0118-3 [68210011803]

Assured Maximum Strength Nasal Decongestant TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-26

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:82d5d61d-8de5-4886-e053-2a91aa0ac831
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049182
  • UPC Code
  • 0639277721976
  • NDC Crossover Matching brand name "Assured Maximum Strength Nasal Decongestant" or generic name "Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    68210-1180Assured Maximum Strength Nasal DecongestantAssured Maximum Strength Nasal Decongestant
    68210-0118Assured Maximum Strength Nasal DecongestantAssured Maximum Strength Nasal Decongestant
    0363-4531Nasal DecongestantPhenylephrine HCl
    30142-953Nasal DecongestantPhenylephrine HCl
    33992-0453Nasal DecongestantPhenylephrine HCl
    21130-453Nasal Decongestant PEPhenylephrine HCl
    37808-453Nasal Decongestant PEPhenylephrine HCl
    36800-704PE Sinus CongestionPhenylephrine HCl
    0536-1291Phenylephrine HClPhenylephrine HCl
    0924-0133PhysiciansCare SinusPhenylephrine HCL
    15127-081PSEUDO-FREE PEPhenylephrine HCl
    0031-9305Robitussin Direct Stuffy NosePhenylephrine hcl
    30142-853Sinus CongestionPhenylephrine HCl
    11673-453sinus PEPhenylephrine HCl
    11822-4530Sinus Pressure and Congestion Relief PEPhenylephrine HCl
    0904-5733Sudogest PEPhenylephrine HCl
    0363-0453Wal-Phed PEPhenylephrine HCl

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