NDC 0904-5304

Major Prep Hemorrhoidal

Hard Fat, Phenylephrine Hcl

Major Prep Hemorrhoidal is a Rectal Suppository in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Phenylephrine Hydrochloride; Fat, Hard.

• Product ID: 0904-5304_9aee4d17-7248-4dcf-b797-c3080530f139
• NDC: 0904-5304
• Product Type: Human Otc Drug
• Proprietary Name: Major Prep Hemorrhoidal
• Generic Name: Hard Fat, Phenylephrine Hcl
• Dosage Form: Suppository
• Route of Administration: RECTAL
• Marketing Start Date: 2008-03-28
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part346
• Labeler Name: Major Pharmaceuticals
• Substance Name: PHENYLEPHRINE HYDROCHLORIDE; FAT, HARD
• Active Ingredient Strength: 74 mg/2.5g; g/2.5g
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 0904-5304-24

24 BLISTER PACK in 1 CARTON (0904-5304-24) > 24 g in 1 BLISTER PACK

• Marketing Start Date: 2008-03-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0904-5304-24 [00904530424]

Major Prep Hemorrhoidal SUPPOSITORY

• Marketing Category: OTC monograph final
• Application Number: part346
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-03-28
• Marketing End Date: 2018-09-23

Drug Details

Active Ingredients

Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	74 mg/2.5g

OpenFDA Data

• SPL SET ID: d47f9fa8-af7b-46c5-af27-3fa1eb5e26da
• Manufacturer:
  • Major Pharmaceuticals
• UNII:
  • 8334LX7S21
  • 04JA59TNSJ

NDC Crossover Matching brand name "Major Prep Hemorrhoidal" or generic name "Hard Fat, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
0904-5304	Major Prep Hemorrhoidal	hard fat, phenylephrine HCl
0904-6356	Major Prep Hemorrhoidal	Mineral Oil, Petrolatum, Phenylephrine Hydrochloride
0904-6726	major prep hemorrhoidal	mineral oil, petrolatum, phenylephrine HCl
72701-110	Bliss GVS Hemorrhoidal	Hard Fat, Phenylephrine HCl
0904-6977	Hemorrhoidal	Hard Fat, Phenylephrine HCl