FDA.reportPublic FDA data

BONINE

Product NDC
65197-275
11-digit product format
651970275
Labeler code
65197
Product ID
65197-275_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
2014-12-15
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

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
65197-275-02BONINE2 in 1 POUCHTABLET, CHEWABLE220
65197-275-08BONINE1 in 1 BOXTABLET, CHEWABLE120
65197-275-08BONINE8 in 1 BLISTER PACKTABLET, CHEWABLE820
65197-275-12BONINE1 in 1 BOXTABLET, CHEWABLE120
65197-275-12BONINE12 in 1 BOTTLETABLET, CHEWABLE1220
65197-275-16BONINE2 in 1 BOXTABLET, CHEWABLE220
65197-275-16BONINE8 in 1 BLISTER PACKTABLET, CHEWABLE820

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65197-275-08EA - Each65197-2752ddf6864-3fac-4ea7-b9c5-15fd749b52e712019-01-24
65197-275-16EA - Each65197-275a30022a7-469f-4336-9342-49a810f580df12022-04-06

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
65197-275BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]20Current NDC, Legacy NDC, 7 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 6 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Airmit AceDIMENHYDRINATESato Pharmaceutical Co., Ltd.a98d252d-4cfa-496a-ab2c-627f45f0d7d92023-12-01WarningsExact identifier
application number: M009
Meclizine HClMECLIZINE HYDROCHLORIDEBluePoint Laboratoriesd9cae5a6-8d4b-bdaf-e053-2995a90a7d442023-11-17WarningsExact identifier
application number: M009
ZenTrip Motion SicknessMECLIZINE HYDROCHLORIDESato Pharmaceutical Co., LTDbd86c4c7-b6f0-e3e8-e053-2995a90a44542023-11-03WarningsExact identifier
application number: M009
Travel-EaseMECLIZINE HCLGeri-Care Pharmaceutical Corpe3c64eb9-4972-29d9-e053-2a95a90a2a8a2023-10-25WarningsExact identifier
application number: M009
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d95240bb-02f2-3226-e053-2995a90afacd2022-03-03WarningsExact identifier
application number: M009
Allergy DyeFreeALLERGY DYEFREEAllegiant Health15736bb8-5a5b-489d-83ad-4cf34ec629562021-04-26WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATE 50MGAllegiant Health7b0aa993-f08f-4dff-a82d-f35b3ebe3cc12019-12-12WarningsExact 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
65197-275-02651970275022 TABLET, CHEWABLE in 1 POUCH (65197-275-02) 2014-12-152026-12-31NoNoCurrent
65197-275-08651970275081 BLISTER PACK in 1 BOX (65197-275-08) / 8 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2014-12-152026-12-31NoNoCurrent
65197-275-12651970275121 BOTTLE in 1 BOX (65197-275-12) / 12 TABLET, CHEWABLE in 1 BOTTLE1 bottle2014-12-152026-12-31NoNoCurrent
65197-275-16651970275162 BLISTER PACK in 1 BOX (65197-275-16) / 8 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2014-12-152026-12-31NoNoCurrent