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 ID54859-605_47dff372-3f9d-48bc-86a3-5d0ee6b3d68e
NDC54859-605
Product TypeHuman Otc Drug
Proprietary NameTusnel Pediatric Drops
Generic NameGuaifenesin, Phenylephrine Hcl
Dosage FormSolution/ Drops
Route of AdministrationORAL
Marketing Start Date2019-08-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Substance NameGUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength25 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54859-605-01

30 mL in 1 BOTTLE, DROPPER (54859-605-01)
Marketing Start Date2019-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54859-605-01 [54859060501]

Tusnel Pediatric Drops SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-08-01

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN25 mg/mL

OpenFDA Data

SPL SET ID:dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2268063
  • NDC Crossover Matching brand name "Tusnel Pediatric Drops" or generic name "Guaifenesin, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    54859-605Tusnel Pediatric DropsGuaifenesin, Phenylephrine HCl
    76864-209BACZOL EXPECTORANTGUAIFENESIN, PHENYLEPHRINE HCl
    45737-606BiophexGuaifenesin, Phenylephrine HCl
    58552-336GilphexGuaifenesin, Phenylephrine HCl
    66576-336GilphexGuaifenesin, Phenylephrine HCl
    58552-332Giltuss Sinus and Chest CongestionGuaifenesin, Phenylephrine HCl
    0363-0542Mucus Relief PEGuaifenesin, Phenylephrine HCl
    68016-686Mucus Relief PEGuaifenesin, Phenylephrine HCl
    70000-0141Mucus Relief PE Sinus CongestionGuaifenesin, Phenylephrine HCl
    59779-548Non-Drying Sinus PEGuaifenesin, Phenylephrine HCl
    21130-927Sinus PEGuaifenesin, Phenylephrine HCl
    50844-548Sinus Relief PEGuaifenesin, Phenylephrine HCl

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