FDA.reportPublic FDA data

BONINE

Product NDC
65197-297
11-digit product format
651970297
Labeler code
65197
Product ID
65197-297_9e33d2ae-5059-4214-b50f-fa5731f6f9ed
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
2025-04-01
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Listing expiration
2027-12-31

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
0b2ea6b8-b342-4940-8922-898758fbeb31Available 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
65197-297-08BONINE8 in 1 BLISTER PACKTABLET, CHEWABLE82
65197-297-08BONINE1 in 1 BOXTABLET, CHEWABLE12
65197-297-12BONINE12 in 1 BOTTLETABLET, CHEWABLE122
65197-297-12BONINE1 in 1 BOXTABLET, CHEWABLE12
65197-297-16BONINE8 in 1 BLISTER PACKTABLET, CHEWABLE82
65197-297-16BONINE2 in 1 BOXTABLET, CHEWABLE22
65197-297-24BONINE3 in 1 CARTONTABLET, CHEWABLE32
65197-297-24BONINE8 in 1 BLISTER PACKTABLET, CHEWABLE82
65197-297-48BONINE3 in 1 CARTONTABLET, CHEWABLE32
65197-297-48BONINE2 in 1 CARTONTABLET, CHEWABLE22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-297BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION]1Current NDC, 10 package rows20250402_0b2ea6b8-b342-4940-8922-898758fbeb31.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 4 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dramamine for KidsDIMENHYDRINATEMedtech Products Inc.12bc3f17-ed62-4d0d-9b1e-3835579e711b2025-09-10WarningsExact identifier
application number: M009
Medique Medi-MeclizineMECLIZINE HCLUnifirst First Aid Corporationb3fec2df-c41d-0b56-e053-2995a90a35e82025-09-09WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HYDROCHLORIDETARGET CORPORATION36ba2950-4a09-e5de-e063-6394a90a17712025-09-04WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5 MGAdvanced Rx LLC032a89f2-17e7-45d2-94a1-cc7a601ebdee2025-09-01WarningsExact identifier
application number: M009
DimenhydrinateDIMENHYDRINATEMajor Pharmaceuticals78d22836-a442-7c0c-e053-2991aa0a62f32025-08-13WarningsExact identifier
application number: M009
MQ Motion PatchMOTION PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.3a70bc22-8e31-2d4c-e063-6394a90a3b242025-07-21WarningsExact identifier
application number: M009
Bangbrek Bee Venom Wart Corn Callus RemoverSALICYLIC ACID 17%Brilliance Trade LLC377946a0-0e8c-70f4-e063-6294a90a1d852025-06-20WarningsExact identifier
application number: M009
Dramamine for KidsDIMENHYDRINATEMedtech Products Inc.48e2e9ef-4c88-42ef-b825-d1b0074752752025-05-06WarningsExact identifier
application number: M009
BONINE MAXMECLIZINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation7326a47e-284e-4b6f-8eb0-7933dc1e3f0d2025-04-11WarningsExact identifier
application number: M009
Meclizine HCL 25 mgMECLIZINE HCLBryant Ranch Prepackd1c58a74-5455-4a07-bcb6-cc114032ed122025-03-31WarningsExact identifier
application number: M009
BONINEMECLIZINE HYDROCHLORIDEWellSpring Pharmaceutical Corporationad3d66ca-a52c-43ba-b9e2-6269b8a413a92025-03-21WarningsExact identifier
application number: M009
BONINEMECLIZINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation0b2ea6b8-b342-4940-8922-898758fbeb312025-03-21WarningsExact identifier
application number: M009
ndc (product): 65197-297
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEWalgreen Companyecf8d05e-0e77-f3e8-e053-2a95a90a66042025-03-11WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 25MGPD-Rx Pharmaceuticals, Inc.cf79ac74-017e-4fb4-85d3-4ea944080e892025-03-06WarningsExact identifier
application number: M009
HIONFURT Motion SicknessMOTION SICKNESS NATURAL HERBAL PLANTPuning Huiyu E-Commerce Co., Ltd.2e2c9073-1dcf-a3e8-e063-6394a90a6ee32025-02-15WarningsExact identifier
application number: M009
HIONFURT Motion SicknessMOTION SICKNESS NATURAL HERBAL PLANT LEMONPuning Huiyu E-Commerce Co., Ltd.2e2b3729-f8b0-605f-e063-6294a90a90c82025-02-15WarningsExact identifier
application number: M009
HIONFURT Motion SicknessMOTION SICKNESS NATURAL HERBAL PLANT LAVENDERPuning Huiyu E-Commerce Co., Ltd.2e30b09d-838d-59fb-e063-6394a90aa9842025-02-15WarningsExact identifier
application number: M009
HIONFURT Motion SicknessMOTION SICKNESS PREVENT NAUSEA,DIZZINESS VOMITINGPuning Huiyu E-Commerce Co., Ltd.2e31419e-3ccd-d7b5-e063-6394a90ac7652025-02-15WarningsExact identifier
application number: M009
Dramamine for KidsDIMENHYDRINATEMedtech Products Inc.3ccd6eb4-ba7e-4a6a-abb9-a6ef3196240c2025-02-12WarningsExact identifier
application number: M009
Motion SicknessMOTION SICKNESS NATURAL HERBAL PLANTPuning Huiyu E-Commerce Co., Ltd.2db09ade-c94b-5f5f-e063-6394a90af9dc2025-02-09WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995634Bonine 25 MG Chewable TabletPSN0b2ea6b8-b342-4940-8922-898758fbeb312
995632meclizine HCl 25 MG Chewable TabletPSN0b2ea6b8-b342-4940-8922-898758fbeb312
995634meclizine hydrochloride 25 MG Chewable Tablet [Bonine]SBD0b2ea6b8-b342-4940-8922-898758fbeb312
995632meclizine hydrochloride 25 MG Chewable TabletSCD0b2ea6b8-b342-4940-8922-898758fbeb312
995634Bonine 25 MG Chewable TabletSY0b2ea6b8-b342-4940-8922-898758fbeb312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65197-297-08651970297081 BLISTER PACK in 1 BOX (65197-297-08) / 8 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2025-04-01NoNoCurrent
65197-297-12651970297121 BOTTLE in 1 BOX (65197-297-12) / 12 TABLET, CHEWABLE in 1 BOTTLE1 bottle2025-04-01NoNoCurrent
65197-297-16651970297162 BLISTER PACK in 1 BOX (65197-297-16) / 8 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2025-04-01NoNoCurrent
65197-297-24651970297243 BLISTER PACK in 1 CARTON (65197-297-24) / 8 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2025-04-01NoNoCurrent
65197-297-48651970297482 CARTON in 1 CARTON (65197-297-48) / 3 BLISTER PACK in 1 CARTON / 8 TABLET, CHEWABLE in 1 BLISTER PACK2 carton2026-05-31NoNoCurrent