Meclizine Hydrochloride
- Product NDC
- 68071-2574
- 11-digit product format
- 680712574
- Labeler code
- 68071
- Product ID
- 68071-2574_49617f72-cc26-7c0d-e063-6294a90ac558
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Meclizine Hydrochloride
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- M009
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-10-30
- 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
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68071-2574-2 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68071-2574-3 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68071-2574-6 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68071-2574-2 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68071-2574-3 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68071-2574-6 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68071-2574-2 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68071-2574-3 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68071-2574-6 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68071-2574-2 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68071-2574-3 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68071-2574-6 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68071-2574-2 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68071-2574-3 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68071-2574-6 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68071-2574-2 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68071-2574-3 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68071-2574-6 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68071-2574-2 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68071-2574-6 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68071-2574-3 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68071-2574-2 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68071-2574-6 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68071-2574-3 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68071-2574-2 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68071-2574-6 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68071-2574-3 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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 Hydrochloride
- 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 |
|---|---|
| d0d8b376-8fe9-8776-e053-2a95a90ae651 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ac6963c4-31c6-325f-ee58-83a0a06597ad | Product name | 5 | 20221206 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 68071-2574-2 | 2026-01-27 | 5172C- Rubgy |
| 68071-2574-3 | 2026-01-27 | 5172C- Rubgy |
| 68071-2574-6 | 2026-01-27 | 5172C- Rubgy |
| 68071-2574-2 | 2025-01-30 | 5172C- Rubgy |
| 68071-2574-3 | 2025-01-30 | 5172C- Rubgy |
| 68071-2574-6 | 2025-01-30 | 5172C- Rubgy |
| 68071-2574-2 | 2023-04-26 | 5172C- Rubgy |
| 68071-2574-3 | 2023-04-26 | 5172C- Rubgy |
| 68071-2574-6 | 2023-04-26 | 5172C- Rubgy |
| 68071-2574-2 | 2023-01-30 | 5172C- Rubgy |
| 68071-2574-3 | 2023-01-30 | 5172C- Rubgy |
| 68071-2574-6 | 2023-01-30 | 5172C- Rubgy |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2574-2 | Meclizine Hydrochloride | 20 in 1 BOTTLE | TABLET, CHEWABLE | 20 | 6 | |
| 68071-2574-3 | Meclizine Hydrochloride | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | 6 | |
| 68071-2574-6 | Meclizine Hydrochloride | 60 in 1 BOTTLE | TABLET, CHEWABLE | 60 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2574 | MECLIZINE HYDROCHLORIDE TABLET, CHEWABLE [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20230920_d0d8b376-8fe9-8776-e053-2a95a90ae651.zip |
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 |
|---|---|---|---|---|
| 995632 | meclizine HCl 25 MG Chewable Tablet | PSN | d0d8b376-8fe9-8776-e053-2a95a90ae651 | 6 |
| 995632 | meclizine hydrochloride 25 MG Chewable Tablet | SCD | d0d8b376-8fe9-8776-e053-2a95a90ae651 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-2574-2 | 68071257402 | 20 TABLET, CHEWABLE in 1 BOTTLE (68071-2574-2) | 2021-11-15 | 0000-00-00 | No | No | Current |
| 68071-2574-3 | 68071257403 | 30 TABLET, CHEWABLE in 1 BOTTLE (68071-2574-3) | 2021-11-15 | 0000-00-00 | No | No | Current |
| 68071-2574-6 | 68071257406 | 60 TABLET, CHEWABLE in 1 BOTTLE (68071-2574-6) | 2021-11-15 | 0000-00-00 | No | No | Current |