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#

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 5 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Motion Sickness ReliefDIMENHYDRINATE 50 MGTARGET CORPORATION28586e9b-01e3-0b88-e063-6394a90af7e02025-01-29WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5MGUlai Health LLCd304e205-85fa-494a-9a68-ae6855b139b12025-01-20WarningsExact identifier
application number: M009
Meclizine HCL 12.5 mgMECLIZINE HCL 12.5 MGReliable 1 Laboratories LLC32832b0f-0b38-27ce-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M009
Meclizine HCL 25 mgMECLIZINE HCLReliable 1 Laboratories LLC32bdd802-16b0-184d-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAPNAR PHARMA LPe4d785a7-a688-3acb-e053-2a95a90a6d2e2025-01-09Boxed warning, WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAPNAR PHARMA LPed43bf21-f3da-245c-e053-2995a90a504c2025-01-09Boxed warning, WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5 MGRUGBY LABORATORIES8a234ce3-eb6b-49dd-9d78-7fc7bdd49d352024-12-20WarningsExact identifier
application number: M009
MeclizineMECLIZINE HYDROCHLORIDEAdvanced Rx LLCb0a2a1f7-354e-48bd-9e98-9207bf9f53fd2024-11-27WarningsExact identifier
application number: M009
Dramamine, TRAVEL BASIXDIMENHYDRINATELil' Drug Store Products, Inc.960a642b-ee7c-4e92-9b5f-930425682dac2024-11-26WarningsExact identifier
application number: M009
Dramamine Less Drowsy, Lil Drug StoreMECLAZINE HYDROCHLORIDE TABLETLil' Drug Store Products, Inc.275b3377-9280-c12c-e063-6294a90a54212024-11-20WarningsExact identifier
application number: M009
PhysiciansCare Motion SicknessMECLIZINE HCLAcme United Corporationc4d3ea22-7c22-7311-e053-2a95a90a779c2024-11-12WarningsExact identifier
application number: M009
DRAMAMINE - NMECLIZINE HYDROCHLORIDEMedtech Products Inc.7fec7791-c242-4e43-8184-32820e657afb2024-10-25WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.f8cf751a-9f19-4744-a350-cd22303435ee2024-10-25WarningsExact identifier
application number: M009
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d955f612-1265-f1be-e053-2995a90a53452024-07-18WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC199ae195-4556-ee88-e063-6394a90a40d42024-06-10WarningsExact identifier
application number: M009
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d941705f-12a1-4757-e053-2995a90ad3fa2024-05-13WarningsExact identifier
application number: M009
Kids Gravol Chewables Motion Sickness DimenhydrinateDIMENHYDRINATEChurch & Dwight Co., Inc.cf6de950-a157-4be2-a302-0dc19511d2f22024-03-01WarningsExact identifier
application number: M009
Gravol Chewables Motion Sickness DimenhydrinateDIMENHYDRINATEChurch & Dwight Co., Inc.de5249f7-79fc-4f3c-965a-1e8ec978a0b72024-03-01WarningsExact identifier
application number: M009
Meclizine HClMECLIZINE HYDROCHLORIDE CHEWABLEBluePoint Laboratoriesd9cc2705-9dcc-0a73-e053-2995a90aafe62024-02-21WarningsExact identifier
application number: M009
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEDeMoulas Market Basketfd04fb94-f581-4ca2-b7ac-20359093863e2023-12-29WarningsExact 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