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 1 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dramamine OrangeDIMENHYDRINATEMedtech Products Inc.76166156-bce1-492f-833e-6bbd07859c3f2026-09-17WarningsExact identifier
application number: M009
Pepto Nausea Motion SicknessMECLIZINE HCLTHE PROCTER & GAMBLE MANUFACTURING COMPANY29a1bd1e-d0e0-478f-e063-6394a90ab0aa2026-09-10WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEA-S Medication Solutions2518b0b6-35ab-49f4-936c-1eafea04b4662026-09-09WarningsExact identifier
application number: M009
Dramamine Less DrowsyMECLIZINE HYDROCHLORIDEMedtech Products Inc.fa6a0969-7427-4b87-bc04-a2792665c2182026-09-04WarningsExact identifier
application number: M009
Less Drowsy Motion Sickness ReliefMECLIZINE HCLWal-Mart Stores Inc277a6266-e641-4621-bbb9-64195d51b66a2026-08-28WarningsExact identifier
application number: M009
Nausea ReliefMECLIZINE HCLWALMART INC.8010741e-61b2-4c1f-9f0e-21612878fa0e2026-08-28WarningsExact identifier
application number: M009
Motion SicknessMECLIZINE HCLH E B9837e9af-c542-4c0f-be33-94927d67c6a72026-08-21WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepackcd82fca9-a8dc-4545-8e64-b67d644832e72026-08-20WarningsExact identifier
application number: M009
Motion SicknessDIMENHYDRINATEStrategic Sourcing Services LLCbe8f91d4-6e4f-4d47-93e9-7fb91160b7df2026-08-17WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEWalgreen Companyace7eba4-e033-48f5-8533-c3ea9dfc32b02026-08-12WarningsExact identifier
application number: M009
Motion SicknessMECLIZINE HCLStrategic Sourcing Services LLC76fb6471-09b0-4c51-bacc-b3533b6aa9712026-08-07WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATECardinal Health 110, LLC. DBA Leaderce83a868-bdd8-4c77-9bc0-664133028f752026-08-06WarningsExact identifier
application number: M009
Less Drowsy Formula Motion Sickness ReliefMECLIZINE HCLSalado Sales, Inc.273235b0-dacc-4a95-91be-91e13a2c6d102026-08-05WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLL.N.K. International, Inc.8e1889de-fbef-44f1-bbfb-c68a78e6330c2026-07-30WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEChain Drug Marketing Association, Inc.00a327c6-6b86-4702-8c04-55c405c1404c2026-07-23WarningsExact identifier
application number: M009
Pepto Motion SicknessMECLIZINE HCLTHE PROCTER & GAMBLE MANUFACTURING COMPANY571e3eeb-ae9e-7054-e063-6394a90a26342026-07-21WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDERugby Laboratoriesb57f14a7-3852-03db-e053-2a95a90a80d62026-07-16WarningsExact identifier
application number: M009
Motion SicknessDIMENHYDRINATECVS Pharmacy0998947c-cfba-497e-bf7a-9c7f8fff17642026-07-16WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLTopco Associates, LLC307e3144-3b01-4bd0-9155-6b58fc4cab922026-07-09WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEL.N.K. International, Inc.95aae32f-6b3f-469d-86a5-c201a53f862a2026-06-29WarningsExact 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