MECLIZINE
- Product NDC
- 80513-427
- 11-digit product format
- 805130427
- Labeler code
- 80513
- Product ID
- 80513-427_3e5a4128-ff9c-6f2b-e063-6394a90a42e6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Meclizine HCl 12.5 mg
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx LLC
- Application
- M009
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-09-01
- Substance
- MECLIZINE HYDROCHLORIDE
- Active strength
- 12.5 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 | 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 |
|---|---|
| 032a89f2-17e7-45d2-94a1-cc7a601ebdee | 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 |
|---|---|---|---|---|---|---|
| 80513-427-02 | MECLIZINE | 200 in 1 BOTTLE, PLASTIC | TABLET | 200 | 1 |
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 |
|---|---|---|---|---|---|---|
| Dramamine Orange | DIMENHYDRINATE | Medtech Products Inc. | 76166156-bce1-492f-833e-6bbd07859c3f | 2026-09-17 | Warnings | M009 |
| Pepto Nausea Motion Sickness | MECLIZINE HCL | THE PROCTER & GAMBLE MANUFACTURING COMPANY | 29a1bd1e-d0e0-478f-e063-6394a90ab0aa | 2026-09-10 | Warnings | M009 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | A-S Medication Solutions | 2518b0b6-35ab-49f4-936c-1eafea04b466 | 2026-09-09 | Warnings | M009 |
| Dramamine Less Drowsy | MECLIZINE HYDROCHLORIDE | Medtech Products Inc. | fa6a0969-7427-4b87-bc04-a2792665c218 | 2026-09-04 | Warnings | M009 |
| Less Drowsy Motion Sickness Relief | MECLIZINE HCL | Wal-Mart Stores Inc | 277a6266-e641-4621-bbb9-64195d51b66a | 2026-08-28 | Warnings | M009 |
| Nausea Relief | MECLIZINE HCL | WALMART INC. | 8010741e-61b2-4c1f-9f0e-21612878fa0e | 2026-08-28 | Warnings | M009 |
| Motion Sickness | MECLIZINE HCL | H E B | 9837e9af-c542-4c0f-be33-94927d67c6a7 | 2026-08-21 | Warnings | M009 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Bryant Ranch Prepack | cd82fca9-a8dc-4545-8e64-b67d644832e7 | 2026-08-20 | Warnings | M009 |
| Motion Sickness | DIMENHYDRINATE | Strategic Sourcing Services LLC | be8f91d4-6e4f-4d47-93e9-7fb91160b7df | 2026-08-17 | Warnings | M009 |
| Motion Sickness Relief | DIMENHYDRINATE | Walgreen Company | ace7eba4-e033-48f5-8533-c3ea9dfc32b0 | 2026-08-12 | Warnings | M009 |
| Motion Sickness | MECLIZINE HCL | Strategic Sourcing Services LLC | 76fb6471-09b0-4c51-bacc-b3533b6aa971 | 2026-08-07 | Warnings | M009 |
| Motion Sickness Relief | DIMENHYDRINATE | Cardinal Health 110, LLC. DBA Leader | ce83a868-bdd8-4c77-9bc0-664133028f75 | 2026-08-06 | Warnings | M009 |
| Less Drowsy Formula Motion Sickness Relief | MECLIZINE HCL | Salado Sales, Inc. | 273235b0-dacc-4a95-91be-91e13a2c6d10 | 2026-08-05 | Warnings | M009 |
| Motion Sickness Relief | MECLIZINE HCL | L.N.K. International, Inc. | 8e1889de-fbef-44f1-bbfb-c68a78e6330c | 2026-07-30 | Warnings | M009 |
| Motion Sickness Relief | DIMENHYDRINATE | Chain Drug Marketing Association, Inc. | 00a327c6-6b86-4702-8c04-55c405c1404c | 2026-07-23 | Warnings | M009 |
| Pepto Motion Sickness | MECLIZINE HCL | THE PROCTER & GAMBLE MANUFACTURING COMPANY | 571e3eeb-ae9e-7054-e063-6394a90a2634 | 2026-07-21 | Warnings | M009 |
| Meclizine Hydrochloride | MECLIZINE HYDROCHLORIDE | Rugby Laboratories | b57f14a7-3852-03db-e053-2a95a90a80d6 | 2026-07-16 | Warnings | M009 |
| Motion Sickness | DIMENHYDRINATE | CVS Pharmacy | 0998947c-cfba-497e-bf7a-9c7f8fff1764 | 2026-07-16 | Warnings | M009 |
| Motion Sickness Relief | MECLIZINE HCL | Topco Associates, LLC | 307e3144-3b01-4bd0-9155-6b58fc4cab92 | 2026-07-09 | Warnings | M009 |
| Motion Sickness Relief | DIMENHYDRINATE | L.N.K. International, Inc. | 95aae32f-6b3f-469d-86a5-c201a53f862a | 2026-06-29 | Warnings | M009 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 995624 | meclizine HCl 12.5 MG Oral Tablet | PSN | 032a89f2-17e7-45d2-94a1-cc7a601ebdee | 1 |
| 995624 | meclizine hydrochloride 12.5 MG Oral Tablet | SCD | 032a89f2-17e7-45d2-94a1-cc7a601ebdee | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80513-427-02 | 80513042702 | 200 TABLET in 1 BOTTLE, PLASTIC (80513-427-02) | 200 tablet | 2025-09-01 | No | No | Current |