Meclizine
- Product NDC
- 80513-421
- 11-digit product format
- 805130421
- Labeler code
- 80513
- Product ID
- 80513-421_27e17bc9-1e66-cc1f-e063-6394a90a4dcb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Meclizine Hydrochloride
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Advanced Rx LLC
- Application
- M009
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-12-01
- 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
- Meclizine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MECLIZINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| HDP7W44CIO | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 995632 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b0a2a1f7-354e-48bd-9e98-9207bf9f53fd | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ac6963c4-31c6-325f-ee58-83a0a06597ad | Product name | 5 | 20221206 |
| ed912195-5da0-0f2f-6f4b-3ef17710cbe3 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80513-421-02 | Meclizine | 200 in 1 BOTTLE | TABLET, CHEWABLE | 200 | 1 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| HIONFURT Motion Sickness | MOTION SICKNESS NATURAL HERBAL PLANT LAVENDER | Puning Huiyu E-Commerce Co., Ltd. | 2e30b09d-838d-59fb-e063-6394a90aa984 | 2025-02-15 | Warnings | M009 |
| HIONFURT Motion Sickness | MOTION SICKNESS PREVENT NAUSEA,DIZZINESS VOMITING | Puning Huiyu E-Commerce Co., Ltd. | 2e31419e-3ccd-d7b5-e063-6394a90ac765 | 2025-02-15 | Warnings | M009 |
| Bedy motion sickness | MOTION SICKNESS RELIEF , NAUSEA RELIEF , SEA SICKNESS | Henan Hengchuntang Pharmaceutical Co., Ltd | 2e3bf94c-4e60-7f78-e063-6394a90a7021 | 2025-02-15 | Warnings | M009 |
| Dramamine for Kids | DIMENHYDRINATE | Medtech Products Inc. | 3ccd6eb4-ba7e-4a6a-abb9-a6ef3196240c | 2025-02-12 | Warnings | M009 |
| Motion Sickness | MOTION SICKNESS NATURAL HERBAL PLANT | Puning Huiyu E-Commerce Co., Ltd. | 2db09ade-c94b-5f5f-e063-6394a90af9dc | 2025-02-09 | Warnings | M009 |
| Motion Sickness Relief | DIMENHYDRINATE 50 MG | TARGET CORPORATION | 28586e9b-01e3-0b88-e063-6394a90af7e0 | 2025-01-29 | Warnings | M009 |
| MECLIZINE | MECLIZINE HCL 12.5MG | Ulai Health LLC | d304e205-85fa-494a-9a68-ae6855b139b1 | 2025-01-20 | Warnings | M009 |
| Meclizine HCL 12.5 mg | MECLIZINE HCL 12.5 MG | Reliable 1 Laboratories LLC | 32832b0f-0b38-27ce-e054-00144ff8d46c | 2025-01-15 | Warnings | M009 |
| Meclizine HCL 25 mg | MECLIZINE HCL | Reliable 1 Laboratories LLC | 32bdd802-16b0-184d-e054-00144ff88e88 | 2025-01-15 | Warnings | M009 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | APNAR PHARMA LP | e4d785a7-a688-3acb-e053-2a95a90a6d2e | 2025-01-09 | Boxed warning, Warnings | M009 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | APNAR PHARMA LP | ed43bf21-f3da-245c-e053-2995a90a504c | 2025-01-09 | Boxed warning, Warnings | M009 |
| MECLIZINE | MECLIZINE HCL 12.5 MG | RUGBY LABORATORIES | 8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35 | 2024-12-20 | Warnings | M009 |
| Meclizine | MECLIZINE HYDROCHLORIDE | Advanced Rx LLC | b0a2a1f7-354e-48bd-9e98-9207bf9f53fd | 2024-11-27 | Warnings | M009 80513-421 |
| Dramamine, TRAVEL BASIX | DIMENHYDRINATE | Lil' Drug Store Products, Inc. | 960a642b-ee7c-4e92-9b5f-930425682dac | 2024-11-26 | Warnings | M009 |
| Dramamine Less Drowsy, Lil Drug Store | MECLAZINE HYDROCHLORIDE TABLET | Lil' Drug Store Products, Inc. | 275b3377-9280-c12c-e063-6294a90a5421 | 2024-11-20 | Warnings | M009 |
| PhysiciansCare Motion Sickness | MECLIZINE HCL | Acme United Corporation | c4d3ea22-7c22-7311-e053-2a95a90a779c | 2024-11-12 | Warnings | M009 |
| DRAMAMINE - N | MECLIZINE HYDROCHLORIDE | Medtech Products Inc. | 7fec7791-c242-4e43-8184-32820e657afb | 2024-10-25 | Warnings | M009 |
| DRAMAMINE | MECLIZINE HYDROCHLORIDE | Medtech Products Inc. | f8cf751a-9f19-4744-a350-cd22303435ee | 2024-10-25 | Warnings | M009 |
| Gravol | DIMENHYDRINATE | Church & Dwight Co., Inc. | d955f612-1265-f1be-e053-2995a90a5345 | 2024-07-18 | Warnings | M009 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 199ae195-4556-ee88-e063-6394a90a40d4 | 2024-06-10 | Warnings | M009 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 995632 | meclizine HCl 25 MG Chewable Tablet | PSN | b0a2a1f7-354e-48bd-9e98-9207bf9f53fd | 1 |
| 995632 | meclizine hydrochloride 25 MG Chewable Tablet | SCD | b0a2a1f7-354e-48bd-9e98-9207bf9f53fd | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 80513-421-02 | 80513042102 | 200 TABLET, CHEWABLE in 1 BOTTLE (80513-421-02) | 2024-12-01 | No | No | Current |