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

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 Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995632, 995634

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

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 carton2026-05-310Current