NDC 65197-296

BONINE

Meclizine Hydrochloride

BONINE is a Oral Tablet, Chewable in the Human Otc Drug category. It is labeled and distributed by Wellspring Pharmaceutical Corporation. The primary component is Meclizine Hydrochloride.

Product ID65197-296_03d25d57-873f-4b4b-b28f-89a1bbe45d4c
NDC65197-296
Product TypeHuman Otc Drug
Proprietary NameBONINE
Generic NameMeclizine Hydrochloride
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2021-08-26
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart336
Labeler NameWellSpring Pharmaceutical Corporation
Substance NameMECLIZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 65197-296-08

1 BLISTER PACK in 1 BOX (65197-296-08) > 8 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date2021-08-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65197-296-08 [65197029608]

BONINE TABLET, CHEWABLE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart336
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-04-19

NDC 65197-296-16 [65197029616]

BONINE TABLET, CHEWABLE
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart336
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-04-19

Drug Details

Active Ingredients

IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:ad3d66ca-a52c-43ba-b9e2-6269b8a413a9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 995634
  • 995632
    • UPC Code
  • 0365197275168

    • NDC Crossover Matching brand name "BONINE" or generic name "Meclizine Hydrochloride"

    NDCBrand NameGeneric Name
    63736-124BonineBonine
    65197-275BONINEBONINE
    65197-296BONINEBONINE
    15579-837Jet-Avert Motion Sickness AidMECLIZINE HYDROCHLORIDE
    16571-751Meclizine HClMECLIZINE HYDROCHLORIDE
    16571-752Meclizine HClMECLIZINE HYDROCHLORIDE
    0440-1736Meclizine Hydrochloridemeclizine hydrochloride
    0536-1299Meclizine HydrochlorideMeclizine Hydrochloride
    0615-1553Meclizine Hydrochloridemeclizine hydrochloride
    0615-1554Meclizine Hydrochloridemeclizine hydrochloride
    0615-8052Meclizine HydrochlorideMeclizine Hydrochloride
    0615-8224Meclizine HydrochlorideMeclizine Hydrochloride
    0904-6517Meclizine HydrochlorideMeclizine Hydrochloride
    10544-108Meclizine Hydrochloridemeclizine hydrochloride
    12634-424Meclizine HydrochlorideMeclizine Hydrochloride
    16571-660Meclizine HydrochlorideMeclizine Hydrochloride
    16571-661Meclizine HydrochlorideMeclizine Hydrochloride
    16571-662Meclizine HydrochlorideMeclizine Hydrochloride
    16571-663Meclizine HydrochlorideMeclizine Hydrochloride
    21695-237Meclizine HydrochlorideMeclizine Hydrochloride
    21695-383Meclizine HydrochlorideMeclizine Hydrochloride
    24689-138Meclizine HydrochlorideMeclizine Hydrochloride
    24689-139Meclizine HydrochlorideMeclizine Hydrochloride
    24689-146Meclizine HydrochlorideMeclizine Hydrochloride
    35356-901MECLIZINE HYDROCHLORIDEMeclizine Hydrochloride
    42291-609Meclizine HydrochlorideMeclizine Hydrochloride
    42708-127Meclizine HydrochlorideMeclizine Hydrochloride
    42806-012Meclizine HydrochlorideMeclizine Hydrochloride
    24385-388Motion sicknessMeclizine Hydrochloride
    0536-1178RugbyMeclizine hydrochloride
    15579-826TRAV-L-TABSMeclizine Hydrochloride
    0363-1407Wal-Dram 2 Quick-Dissolvingmeclizine hydrochloride

    Trademark Results [BONINE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BONINE
    BONINE
    97702096 not registered Live/Pending
    WellSpring Pharmaceutical Corporation
    2022-12-02
    BONINE
    BONINE
    97702094 not registered Live/Pending
    WellSpring Pharmaceutical Corporation
    2022-12-02
    BONINE
    BONINE
    88318057 not registered Live/Pending
    WELLSPRING PHARMACEUTICAL CORPORATION
    2019-02-27
    BONINE
    BONINE
    72081199 0697007 Live/Registered
    CHAS. PFIZER & CO., INC.
    1959-09-11
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.