NDC 68210-1180

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 ID: 68210-1180_82d60239-4861-7a7a-e053-2991aa0ab42a
• NDC: 68210-1180
• Product Type: Human Otc Drug
• Proprietary Name: Assured Maximum Strength Nasal Decongestant
• Generic Name: Phenylephrine Hcl
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-02-26
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Spirit Pharmaceuticals LLC
• Substance Name: PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68210-1180-2

1 BLISTER PACK in 1 CARTON (68210-1180-2) > 24 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2019-02-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68210-1180-2 [68210118002]

Assured Maximum Strength Nasal Decongestant TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-02-26

Drug Details

Active Ingredients

Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	10 mg/1

OpenFDA Data

• SPL SET ID: 3913362c-30a3-4803-a19b-91b5f7122f2f
• Manufacturer:
  • Spirit Pharmaceuticals LLC
• UNII:
  • 04JA59TNSJ
• RxNorm Concept Unique ID - RxCUI:
  • 1049182
• UPC Code:
  • 0639277721976

NDC Crossover Matching brand name "Assured Maximum Strength Nasal Decongestant" or generic name "Phenylephrine Hcl"

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