Meclizine HCL
- Product NDC
- 71610-528
- 11-digit product format
- 716100528
- Labeler code
- 71610
- Product ID
- 71610-528_2b4cfbd3-496d-100d-e063-6294a90aba52
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Meclizine HCl 25mg Chewable Tablets
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-05-01
- Substance
- MECLIZINE HYDROCHLORIDE
- Active strength
- 25 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 | 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 |
|---|---|
| 02d1af4d-d97d-4019-a5bf-3ec391238676 | 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 |
|---|---|---|---|---|---|---|
| 71610-528-30 | Meclizine HCL | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | 2 | |
| 71610-528-60 | Meclizine HCL | 90 in 1 BOTTLE | TABLET, CHEWABLE | 90 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71610-528-30 | EA - Each | 71610-528 | 2e96690d-35b4-4dc8-ad74-416b6d0fdf5e | 1 | 2021-05-05 |
| 71610-528-60 | EA - Each | 71610-528 | cf04b58f-2e24-45dc-a9fa-7480c3765f72 | 1 | 2021-05-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71610-528 | MECLIZINE HCL (MECLIZINE HCL 25MG CHEWABLE TABLETS) TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20250112_02d1af4d-d97d-4019-a5bf-3ec391238676.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 |
|---|---|---|---|---|---|---|
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | TARGET CORPORATION | 135d2212-2122-b7a1-e063-6294a90aa5f5 | 2024-06-07 | Warnings | M012 |
| up and up daytime honey cold flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Target Corporation | 29da4b94-8f8e-48e8-909f-8476e3b39d78 | 2024-06-06 | Warnings | M012 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | TARGET Corporation | e3da3003-88e3-4431-8b65-e61e17728901 | 2024-06-04 | Warnings | M012 |
| Dimetapp Cold and Allergy | BROMPHENIRAMINE MALEATE | Foundation Consumer Healthcare | 15c3570c-bd00-8e43-e063-6294a90a8683 | 2024-06-01 | Warnings | M012 |
| Dimetapp Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Foundation Consumer Healthcare | 176be362-5237-edd8-e063-6294a90a4aef | 2024-06-01 | Warnings | M012 |
| Dimetapp Nighttime Cold and Cough | DIPHENHYDRAMINE HYDROCHLORIDE | Foundation Consumer Healthcare | 179115ad-d610-99b2-e063-6294a90ae711 | 2024-06-01 | Warnings | M012 |
| Dimetapp Cold and Cough and Nighttime Cold and Cough | DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Foundation Consumer Healthcare | 179259a9-231e-df03-e063-6294a90a145e | 2024-06-01 | Warnings | M012 |
| Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Cough | BROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE | Foundation Consumer Healthcare | 1820e7c7-bc11-9061-e063-6394a90ae581 | 2024-06-01 | Warnings | M012 |
| Theraflu Severe Cold Relief Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 2024-06-01 | Warnings | M012 |
| Maximum Strength Nasal Decongestant | OXYMETAZOLINE SPRAY | CVS Health | df1f8bda-7bf3-4755-9169-f2a81d824cbe | 2024-05-31 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | CVS Health | a78d29ed-019b-4014-ae6f-c60c75d19c89 | 2024-05-31 | Warnings | M012 |
| Leader Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Cardinal Health 110,Inc | 6594c117-6ffc-4bda-8bbf-e91c810f2c3f | 2024-05-31 | Warnings | M012 |
| Nighttime Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | United Natural Foods, Inc. dba UNFI | 1aba9b7c-8328-4a9f-8ce2-39648b2d8ae4 | 2024-05-23 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | fdf63308-fe7b-4613-a012-ed5e4c9f8ffe | 2024-05-23 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | e61ab02d-f932-403f-a4f7-0ca354607223 | 2024-05-23 | Warnings | M012 |
| Daytime Cold and Flu Relief Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | e4f9a846-ab72-4508-b0c5-f7911af2f3d7 | 2024-05-23 | Warnings | M012 |
| Adult Cough Relief | DEXTROMETHORPHAN HBR | QUALITY CHOICE (Chain Drug Marketing Association) | 6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c | 2024-05-20 | Warnings | M012 |
| Chlorpheniramine Maleate 4 mg | CHLORPHENIRAMINE MALEATE | Bryant Ranch Prepack | 54681242-c861-4415-b5c0-d3ab55b62be1 | 2024-05-17 | Warnings | M012 |
| Dibromm Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | c830b18b-4427-4530-9bc7-85c2735080d2 | 2024-05-17 | Warnings | M012 |
| Childrens Cold and Cough Nighttime | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Safeway, Inc. | cbbec807-f882-4c6a-b1cd-c7fd5ce70cad | 2024-05-15 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 995632 | meclizine HCl 25 MG Chewable Tablet | PSN | 02d1af4d-d97d-4019-a5bf-3ec391238676 | 2 |
| 995632 | meclizine hydrochloride 25 MG Chewable Tablet | SCD | 02d1af4d-d97d-4019-a5bf-3ec391238676 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71610-528-30 | 71610052830 | 30 TABLET, CHEWABLE in 1 BOTTLE (71610-528-30) | 2021-03-04 | 0000-00-00 | No | No | Current |
| 71610-528-60 | 71610052860 | 90 TABLET, CHEWABLE in 1 BOTTLE (71610-528-60) | 2021-03-04 | 0000-00-00 | No | No | Current |