BONINE
- Product NDC
- 65197-296
- 11-digit product format
- 651970296
- Labeler code
- 65197
- Product ID
- 65197-296_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
- 2023-02-15
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BONINE
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MECLIZINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HDP7W44CIO |
| Rxcui | 995632, 995634 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65197-296-08 | BONINE | 1 in 1 BOX | TABLET, CHEWABLE | 1 | | 20 |
| 65197-296-08 | BONINE | 8 in 1 BLISTER PACK | TABLET, CHEWABLE | 8 | | 20 |
| 65197-296-12 | BONINE | 12 in 1 BOTTLE | TABLET, CHEWABLE | 12 | | 20 |
| 65197-296-12 | BONINE | 1 in 1 BOX | TABLET, CHEWABLE | 1 | | 20 |
| 65197-296-16 | BONINE | 8 in 1 BLISTER PACK | TABLET, CHEWABLE | 8 | | 20 |
| 65197-296-16 | BONINE | 2 in 1 BOX | TABLET, CHEWABLE | 2 | | 20 |
| 65197-296-24 | BONINE | 8 in 1 BLISTER PACK | TABLET, CHEWABLE | 8 | | 20 |
| 65197-296-24 | BONINE | 3 in 1 CARTON | TABLET, CHEWABLE | 3 | | 20 |
| 65197-296-32 | BONINE | 8 in 1 BLISTER PACK | TABLET, CHEWABLE | 8 | | 20 |
| 65197-296-32 | BONINE | 4 in 1 CARTON | TABLET, CHEWABLE | 4 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MECLIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | HDP7W44CIO | BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] | 3 | |
| MECLIZINE | ACTIVE MOIETY | 3L5TQ84570 | BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] | 3 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] | 3 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65197-296 | BONINE (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [WELLSPRING PHARMACEUTICAL CORPORATION] | 20 | Current NDC, Legacy NDC, 10 package rows | 20250330_ad3d66ca-a52c-43ba-b9e2-6269b8a413a9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65197-296-08 | 65197029608 | 1 BLISTER PACK in 1 BOX (65197-296-08) / 8 TABLET, CHEWABLE in 1 BLISTER PACK | 1 blister pack | 2023-02-15 | 2026-12-31 | No | No | Current |
| 65197-296-12 | 65197029612 | 1 BOTTLE in 1 BOX (65197-296-12) / 12 TABLET, CHEWABLE in 1 BOTTLE | 1 bottle | 2023-02-15 | 2026-10-31 | No | No | Current |
| 65197-296-16 | 65197029616 | 2 BLISTER PACK in 1 BOX (65197-296-16) / 8 TABLET, CHEWABLE in 1 BLISTER PACK | 2 blister pack | 2023-02-15 | 2026-12-31 | No | No | Current |
| 65197-296-24 | 65197029624 | 3 BLISTER PACK in 1 CARTON (65197-296-24) / 8 TABLET, CHEWABLE in 1 BLISTER PACK | 3 blister pack | 2023-05-01 | 2026-12-31 | No | No | Historical |
| 65197-296-32 | 65197029632 | 8 in 1 BLISTER PACK | | | | | | Historical |