Meclizine HCl
- Product NDC
- 68001-528
- 11-digit product format
- 680010528
- Labeler code
- 68001
- Product ID
- 68001-528_097bfb09-4450-bd70-e063-6294a90a91b7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MECLIZINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- M009
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-03-14
- Substance
- MECLIZINE HYDROCHLORIDE
- Active strength
- 12.5 mg/1
- Pharmacologic classes
- Antiemetic [EPC], Emesis Suppression [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MECLIZINE HYDROCHLORIDE | 12.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| HDP7W44CIO | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 995624 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d9cae5a6-8d4b-bdaf-e053-2995a90a7d44 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ac6963c4-31c6-325f-ee58-83a0a06597ad | Product name | 5 | 20221206 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68001-528-00 | Meclizine HCl | 100 in 1 BOTTLE | TABLET | 100 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68001-528-00 | EA - Each | 68001-528 | 2946ba4e-e8da-44a9-b239-df3aa92349e7 | 1 | 2022-04-06 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| Gravol | DIMENHYDRINATE | Church & Dwight Co., Inc. | d941705f-12a1-4757-e053-2995a90ad3fa | 2024-05-13 | Warnings | M009 |
| Kids Gravol Chewables Motion Sickness Dimenhydrinate | DIMENHYDRINATE | Church & Dwight Co., Inc. | cf6de950-a157-4be2-a302-0dc19511d2f2 | 2024-03-01 | Warnings | M009 |
| Gravol Chewables Motion Sickness Dimenhydrinate | DIMENHYDRINATE | Church & Dwight Co., Inc. | de5249f7-79fc-4f3c-965a-1e8ec978a0b7 | 2024-03-01 | Warnings | M009 |
| Meclizine HCl | MECLIZINE HYDROCHLORIDE CHEWABLE | BluePoint Laboratories | d9cc2705-9dcc-0a73-e053-2995a90aafe6 | 2024-02-21 | Warnings | M009 |
| Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | DeMoulas Market Basket | fd04fb94-f581-4ca2-b7ac-20359093863e | 2023-12-29 | Warnings | M009 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 995624 | meclizine HCl 12.5 MG Oral Tablet | PSN | d9cae5a6-8d4b-bdaf-e053-2995a90a7d44 | 2 |
| 995624 | meclizine hydrochloride 12.5 MG Oral Tablet | SCD | d9cae5a6-8d4b-bdaf-e053-2995a90a7d44 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68001-528-00 | 68001052800 | 100 TABLET in 1 BOTTLE (68001-528-00) | 100 tablet | 2022-03-14 | 0000-00-00 | No | No | Current |