NDC 58552-313

Gilphex TR

Guaifenesin And Phenylephrine Hcl

Gilphex TR is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Gil Pharmaceutical Corp. The primary component is Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 58552-313_7925e3dd-4b05-31b5-e053-2991aa0aba7b
• NDC: 58552-313
• Product Type: Human Otc Drug
• Proprietary Name: Gilphex TR
• Generic Name: Guaifenesin And Phenylephrine Hcl
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2008-02-12
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Gil Pharmaceutical Corp
• Substance Name: GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 388 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 58552-313-01

100 TABLET, FILM COATED in 1 BOTTLE (58552-313-01)

• Marketing Start Date: 2011-05-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58552-313-01 [58552031301]

Gilphex TR TABLET, FILM COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-05-13

NDC 58552-313-02 [58552031302]

Gilphex TR TABLET, FILM COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-07-15

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	388 mg/1

OpenFDA Data

• SPL SET ID: 80a33cba-9577-402a-84bc-1507c439c933
• Manufacturer:
  • Gil Pharmaceutical Corp
• UNII:
  • 04JA59TNSJ
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1946782
  • 1946784

NDC Crossover Matching brand name "Gilphex TR" or generic name "Guaifenesin And Phenylephrine Hcl"

NDC	Brand Name	Generic Name
58552-313	Gilphex TR	Guaifenesin and Phenylephrine HCl
50991-736	Deconex IR	Guaifenesin and Phenylephrine HCl
69168-354	Mucus Relief D	Guaifenesin and Phenylephrine HCl
21130-542	Mucus Relief PE	Guaifenesin and Phenylephrine HCl
0904-5792	Mucus Relief Sinus	Guaifenesin and Phenylephrine HCl
63187-587	Mucus Relief Sinus	Guaifenesin and Phenylephrine HCl
68788-7872	Mucus Relief Sinus	Guaifenesin and Phenylephrine HCl
11822-0542	Sinus Congestion PE	Guaifenesin and Phenylephrine HCl
68788-0845	Sinus Congestion PE	Guaifenesin and Phenylephrine HCl