NDC 46084-051

GUAAP

Guaifenesin

GUAAP is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by A P J Laboratories Limited. The primary component is Guaifenesin.

Product ID46084-051_b4133ea4-5e75-46d7-80b4-e7350c8ce234
NDC46084-051
Product TypeHuman Otc Drug
Proprietary NameGUAAP
Generic NameGuaifenesin
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2013-03-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameA P J Laboratories Limited
Substance NameGUAIFENESIN
Active Ingredient Strength100 mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 46084-051-21

120 mL in 1 BOTTLE (46084-051-21)
Marketing Start Date2013-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46084-051-21 [46084005121]

GUAAP LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-03-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/5mL

OpenFDA Data

SPL SET ID:6f6f3aae-a676-4b91-bad3-2a1c798ffe0a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310604
  • NDC Crossover Matching brand name "GUAAP" or generic name "Guaifenesin"

    NDCBrand NameGeneric Name
    46084-051GUAAPGUAAP
    0363-0288childrens chest congestionGuaifenesin
    0113-0325Good Sense Mucus ERGuaifenesin
    0113-2023good sense mucus erguaifenesin
    0113-3650Good Sense Mucus ERGuaifenesin
    0113-0061good sense tussinGuaifenesin
    0121-0744GUAIFENESINGUAIFENESIN
    0121-1488GUAIFENESINGUAIFENESIN
    0121-1744GUAIFENESINGUAIFENESIN
    0121-2232GUAIFENESINGUAIFENESIN
    0363-0028GuaifenesinGuaifenesin
    0363-0033GuaifenesinGuaifenesin
    0363-0071MucusGuaifenesin
    0363-0074MucusGuaifenesin
    0363-0532Mucus ReliefGuaifenesin
    0363-0325mucus relief erGuaifenesin
    0031-9303Robitussin Direct Chest Congestionguaifenesin
    0031-8724Robitussin Mucus Plus Chest CongestionGuaifenesin
    0113-2061tussinGuaifenesin
    0363-0310wal tussinGuaifenesin

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.