NDC 58552-131

Giltuss Childrens Cough and Cold

Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

Giltuss Childrens Cough and Cold is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Gil Pharmaceutical Corp. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID58552-131_852b77ae-a59a-3ead-e053-2a91aa0a54bd
NDC58552-131
Product TypeHuman Otc Drug
Proprietary NameGiltuss Childrens Cough and Cold
Generic NameDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-11-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGil Pharmaceutical Corp
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength8 mg/2.5mL; mg/2.5mL; mg/2.5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58552-131-04

1 BOTTLE in 1 CARTON (58552-131-04) > 118 mL in 1 BOTTLE
Marketing Start Date2018-11-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58552-131-04 [58552013104]

Giltuss Childrens Cough and Cold SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2018-11-07

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE7.5 mg/2.5mL

OpenFDA Data

SPL SET ID:852b77ae-a5ac-3ead-e053-2a91aa0a54bd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1251031
  • NDC Crossover Matching brand name "Giltuss Childrens Cough and Cold" or generic name "Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    58552-131Giltuss Childrens Cough and ColdGiltuss Childrens Cough and Cold
    0113-7400basic care mucus relief severe congestion and coughDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    49963-381BrontussDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    49963-813BrontussDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    49963-913BrontussDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    41520-937CareOne Tussin CFDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    11584-1046DESPECDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    11584-1110DespecDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    41163-388equaline tussinDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    49035-516Equate Tussin CFDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    30142-454fast mucus reliefdextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    24385-904Good Neighbor Pharmacy Tussin CFDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    0113-0703Good Sense Tussin CFDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    37808-317H E B MAX SEVERE CONGESTION and COUGHDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
    41520-037Mucus Reliefdextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    0363-0337Mucus Relief Severe Congestion and Coughdextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    0363-0681Mucus Relief Severe Congestion and Coughdextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    41250-605multi symptom coldDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    41190-516ShopRite Adult TussinDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    49738-280smart sense multi symptom coldDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    49873-306Stona Coughdextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
    49348-737SUNMARK TUSSIN CFDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    36800-516topcare tussin CFDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    50066-504Tukol Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
    30142-516tussin cfDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    37012-516Tussin CFDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
    0363-0516Wal TussinDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

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