FDA.reportPublic FDA data

BONINE

Product NDC
65197-296
11-digit product format
651970296
Labeler code
65197
Product ID
65197-296_7c66f984-240b-40dc-affd-9f1562f57c7c
Type
HUMAN OTC DRUG
Nonproprietary name
meclizine hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
WellSpring Pharmaceutical Corporation
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-15
Marketing end
2026-12-31
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65197-29665197-296-32DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65197-29665197-296-32DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65197-29665197-296-32DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
BONINE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HDP7W44CIOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995632Internal RxNorm lookup
995634Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ad3d66ca-a52c-43ba-b9e2-6269b8a413a9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-296-08BONINE1 in 1 BOXTABLET, CHEWABLE120
65197-296-08BONINE8 in 1 BLISTER PACKTABLET, CHEWABLE820
65197-296-12BONINE12 in 1 BOTTLETABLET, CHEWABLE1220
65197-296-12BONINE1 in 1 BOXTABLET, CHEWABLE120
65197-296-16BONINE8 in 1 BLISTER PACKTABLET, CHEWABLE820
65197-296-16BONINE2 in 1 BOXTABLET, CHEWABLE220
65197-296-24BONINE8 in 1 BLISTER PACKTABLET, CHEWABLE820
65197-296-24BONINE3 in 1 CARTONTABLET, CHEWABLE320
65197-296-32BONINE8 in 1 BLISTER PACKTABLET, CHEWABLE820
65197-296-32BONINE4 in 1 CARTONTABLET, CHEWABLE420

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOBONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]3
MECLIZINEACTIVE MOIETY3L5TQ84570BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GBONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-296BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]20Current NDC, Legacy NDC, 10 package rows20250330_ad3d66ca-a52c-43ba-b9e2-6269b8a413a9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DimenhydrinateDIMENHYDRINATELEADER/ Cardinal Health 110, Inc.7c4adbdb-9bce-0c9c-e053-2a91aa0a81072026-02-20WarningsExact identifier
application number: M009
Dramamine Less DrowsyMECLIZINE HYDROCHLORIDENavajo Manufacturing Company Inc.4b203479-ba8d-7237-e063-6294a90ae6cb2026-02-18WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.d0d8b376-8fe9-8776-e053-2a95a90ae6512026-01-27WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4f806804-48c7-414e-a177-5d3daf5b22e32026-01-20WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 25 MGBi-Mart2e2c8189-c026-48f8-bbc6-371498ccf4442026-01-13WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLUnited Natural Foods, Inc. dba UNFI108bb943-529f-4510-b770-b54eca493ae02026-01-12WarningsExact identifier
application number: M009
Less Drowsy Motion Sickness ReliefMECLIZINE HCLRite Aid Corporation2f9ebe6b-ffde-41de-9eaa-b03d87d330052026-01-09WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATERite Aid Corporation4f532984-aeee-4dde-972c-742bdf12868f2026-01-07WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLFamily Dollar Services Ince34126e3-52ef-4999-bf61-cba9b18182592026-01-05WarningsExact identifier
application number: M009
CVS Motion Sickness Fast MeltingMECLIZINE HYDROCHLORIDECVS Pharmacy, Inc.2a723bce-a581-4558-b028-22f1f9125dd52025-12-30WarningsExact identifier
application number: M009
Wal-Dram 2 Quick-DissolvingMECLIZINE HYDROCHLORIDEWalgreen Co.f3116203-1b8f-438a-b779-7bdd90eaf79e2025-12-30WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5 MGPharbest Pharmaceuticals, Inc.8b3c9283-b618-4d57-9f15-7cf73e8737f52025-12-24WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 25MGPharbest Pharmaceuticals, Inc.4bac2765-045c-405e-8006-8c5cfdfa89bc2025-12-24WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.fdcbcc4e-9370-4975-8905-1f12c73fdc8c2025-12-23WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.3a960d43-62aa-464e-92b9-d83042ba02bf2025-12-23WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.6efd3473-ee14-4ee0-8a58-d15a64a9224a2025-12-18WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLRite Aid Corporatione599dc64-ac10-4f4e-9318-e9fab05264882025-11-15WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLKroger Company64e0496c-5e09-46e9-94b9-624163d71b602025-11-05WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLWalgreen Company27bd9c74-c85e-4eeb-9e43-4120f90011872025-11-05WarningsExact identifier
application number: M009
Dramamine Original FormulaDIMENHYDRINATEMedtech Products Inc.f9302a5a-295a-4501-9332-e3f5eb3873622025-10-23WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995634Bonine 25 MG Chewable TabletPSNad3d66ca-a52c-43ba-b9e2-6269b8a413a920
995632meclizine HCl 25 MG Chewable TabletPSNad3d66ca-a52c-43ba-b9e2-6269b8a413a920
995634meclizine hydrochloride 25 MG Chewable Tablet [Bonine]SBDad3d66ca-a52c-43ba-b9e2-6269b8a413a920
995632meclizine hydrochloride 25 MG Chewable TabletSCDad3d66ca-a52c-43ba-b9e2-6269b8a413a920
995634Bonine 25 MG Chewable TabletSYad3d66ca-a52c-43ba-b9e2-6269b8a413a920

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65197-296-08651970296081 BLISTER PACK in 1 BOX (65197-296-08) / 8 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2023-02-152026-12-31NoNoCurrent
65197-296-12651970296121 BOTTLE in 1 BOX (65197-296-12) / 12 TABLET, CHEWABLE in 1 BOTTLE1 bottle2023-02-152026-10-31NoNoCurrent
65197-296-16651970296162 BLISTER PACK in 1 BOX (65197-296-16) / 8 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2023-02-152026-12-31NoNoCurrent
65197-296-24651970296243 BLISTER PACK in 1 CARTON (65197-296-24) / 8 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2023-05-012026-12-31NoNoHistorical
65197-296-32651970296328 in 1 BLISTER PACKHistorical