NDC 16571-301

Guaifenesin DAC

Guaifenesin, Codeine Phosphate And Pseudoephedrine Hydrochloride

Guaifenesin DAC is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Rising Pharmaceuticals. The primary component is Guaifenesin; Codeine Phosphate; Pseudoephedrine Hydrochloride.

Product ID16571-301_08a574fb-ce43-4859-a5cf-6f62bd0ca09e
NDC16571-301
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin DAC
Generic NameGuaifenesin, Codeine Phosphate And Pseudoephedrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2016-02-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameRising Pharmaceuticals
Substance NameGUAIFENESIN; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength100 mg/5mL; mg/5mL; mg/5mL
DEA ScheduleCV
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 16571-301-16

473 mL in 1 BOTTLE (16571-301-16)
Marketing Start Date2016-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16571-301-16 [16571030116]

Guaifenesin DAC LIQUID
Marketing CategoryUNAPPROVED DRUG OTHER
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2016-02-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/5mL

OpenFDA Data

SPL SET ID:c5b23fbe-c6ff-4238-9647-d20311bb3405
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995983
  • UPC Code
  • 0316571301164

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