NDC 58354-111

Colcol-S

Acetaminophen, Chlorpheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide Hydrate, Guaifenesin

Colcol-S is a Oral Capsule in the Human Otc Drug category. It is labeled and distributed by Cho-a Pharm.co.,ltd.. The primary component is Guaifenesin; Acetaminophen; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride; Chlorpheniramine Maleate.

Product ID58354-111_827109a5-9c37-f361-e053-2a91aa0a4738
NDC58354-111
Product TypeHuman Otc Drug
Proprietary NameColcol-S
Generic NameAcetaminophen, Chlorpheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide Hydrate, Guaifenesin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-02-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameCho-A Pharm.Co.,Ltd.
Substance NameGUAIFENESIN; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active Ingredient Strength21 mg/320mg; mg/320mg; mg/320mg; mg/320mg; mg/320mg
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58354-111-03

1 BLISTER PACK in 1 BOX (58354-111-03) > 10 CAPSULE in 1 BLISTER PACK (58354-111-02) > 320 mg in 1 CAPSULE (58354-111-01)
Marketing Start Date2019-02-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58354-111-02 [58354011102]

Colcol-S CAPSULE
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-21

NDC 58354-111-01 [58354011101]

Colcol-S CAPSULE
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-21

NDC 58354-111-03 [58354011103]

Colcol-S CAPSULE
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-02-21

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN21 mg/320mg

OpenFDA Data

SPL SET ID:82719258-a8a7-1885-e053-2991aa0a843c
Manufacturer
UNII

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