NDC 0498-1071

Antidiarrheal Relief

Loperamide Hcl

Antidiarrheal Relief is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Honeywell Safety Products Usa, Inc. The primary component is Loperamide Hydrochloride.

Product ID0498-1071_79fe32e3-05db-7f3a-e053-2991aa0a25b0
NDC0498-1071
Product TypeHuman Otc Drug
Proprietary NameAntidiarrheal Relief
Generic NameLoperamide Hcl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-04-29
Marketing CategoryANDA / ANDA
Application NumberANDA074091
Labeler NameHoneywell Safety Products USA, Inc
Substance NameLOPERAMIDE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0498-1071-07

100 PACKET in 1 CARTON (0498-1071-07) > 1 TABLET in 1 PACKET (0498-1071-00)
Marketing Start Date2018-11-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0498-1071-07 [00498107107]

Antidiarrheal Relief TABLET
Marketing CategoryANDA
Application NumberANDA074091
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-07

NDC 0498-1071-00 [00498107100]

Antidiarrheal Relief TABLET
Marketing CategoryANDA
Application NumberANDA074091
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-04-29

Drug Details

Active Ingredients

IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:98fdf3b6-f883-40dd-afba-c7b241638f90
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 978010
  • NDC Crossover Matching brand name "Antidiarrheal Relief" or generic name "Loperamide Hcl"

    NDCBrand NameGeneric Name
    0498-1071Antidiarrheal ReliefLoperamide HCl
    10202-2247 Select Anti DiarrhealLoperamide HCl
    10202-6457 select anti diarrhealloperamide HCl
    0113-2224anti diarrhealLoperamide HCl
    0363-1010anti diarrhealLoperamide HCl
    0363-2022Anti Diarrhealloperamide HCl
    0363-0375Anti-DiarrhealLoperamide HCl
    11822-0375Anti-DiarrhealLoperamide HCl
    0113-1645Good Sense antidiarrhealloperamide HCl
    0113-0645good sense loperamide hydrochlorideloperamide HCl
    0113-6004injoy diarrhea reliefLoperamide HCl
    0113-7224loperamide hydrochlorideLoperamide HCl
    0363-0645loperamide hydrochlorideloperamide HCl
    0363-1645loperamide hydrochlorideloperamide HCl
    0904-6256loperamide hydrochlorideloperamide HCl
    0904-6836loperamide hydrochlorideloperamide HCl
    11822-1645loperamide hydrochlorideloperamide HCl
    11822-5519loperamide hydrochlorideloperamide HCl
    11673-900Up and Up anti diarrhealloperamide HCl

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