NDC 54859-605

Tusnel Pediatric Drops

Guaifenesin, Phenylephrine Hcl

Tusnel Pediatric Drops is a Oral Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Llorens Pharmaceuticals International Division. The primary component is Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 54859-605_47dff372-3f9d-48bc-86a3-5d0ee6b3d68e
• NDC: 54859-605
• Product Type: Human Otc Drug
• Proprietary Name: Tusnel Pediatric Drops
• Generic Name: Guaifenesin, Phenylephrine Hcl
• Dosage Form: Solution/ Drops
• Route of Administration: ORAL
• Marketing Start Date: 2019-08-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
• Substance Name: GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 25 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 54859-605-01

30 mL in 1 BOTTLE, DROPPER (54859-605-01)

• Marketing Start Date: 2019-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54859-605-01 [54859060501]

Tusnel Pediatric Drops SOLUTION/ DROPS

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-08-01

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	25 mg/mL

OpenFDA Data

• SPL SET ID: dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7
• Manufacturer:
  • LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
• UNII:
  • 04JA59TNSJ
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 2268063

NDC Crossover Matching brand name "Tusnel Pediatric Drops" or generic name "Guaifenesin, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
54859-605	Tusnel Pediatric Drops	Guaifenesin, Phenylephrine HCl
76864-209	BACZOL EXPECTORANT	GUAIFENESIN, PHENYLEPHRINE HCl
45737-606	Biophex	Guaifenesin, Phenylephrine HCl
58552-336	Gilphex	Guaifenesin, Phenylephrine HCl
66576-336	Gilphex	Guaifenesin, Phenylephrine HCl
58552-332	Giltuss Sinus and Chest Congestion	Guaifenesin, Phenylephrine HCl
0363-0542	Mucus Relief PE	Guaifenesin, Phenylephrine HCl
68016-686	Mucus Relief PE	Guaifenesin, Phenylephrine HCl
70000-0141	Mucus Relief PE Sinus Congestion	Guaifenesin, Phenylephrine HCl
59779-548	Non-Drying Sinus PE	Guaifenesin, Phenylephrine HCl
21130-927	Sinus PE	Guaifenesin, Phenylephrine HCl
50844-548	Sinus Relief PE	Guaifenesin, Phenylephrine HCl