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 |
|---|---|---|---|---|---|---|
| Theraflu ExpressMax Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 62f7fcb9-e31a-4634-b1c2-44a9567e3a61 | 2024-03-07 | Warnings | M012 |
| Theraflu ExpressMax Severe Cold and Flu Caplets | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 8e22f6bc-33ce-4bb0-99be-7947aa21f60e | 2024-03-07 | Warnings | M012 |
| Theraflu ExpressMax Severe Cold and Flu Syrup | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 777d2ac7-e3cc-4513-8b6f-b90b2ff2c672 | 2024-03-07 | Warnings | M012 |
| Childrens Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | CVS Pharmacy | 4c6025ff-4982-4408-b077-75dd5f5b65b2 | 2024-03-07 | Warnings | M012 |
| Daytime Cold and Flu Non Drowsy | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS Pharmacy | 423fd5e6-5d90-4539-81e0-0ae23881ee3a | 2024-03-07 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | 917df706-1982-4240-9f56-42d426b76cc5 | 2024-03-06 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 21a29998-29d6-4a36-a370-291d23bfb197 | 2024-03-05 | Warnings | M012 |
| Multi-Symptom Cold and Flu DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 3c7ef3cf-f7f9-42bc-bf20-e36954b9671f | 2024-03-05 | Warnings | M012 |
| QUALITY CHOICE NightTime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | da06e994-6848-4c1e-9432-31de5e626ea4 | 2024-03-02 | Warnings | M012 |
| QUALITY CHOICE DayTime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | 417c4fa9-6458-40d0-b22a-2415194e250f | 2024-03-02 | Warnings | M012 |
| DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Aurohealth LLC | 8eaa0eec-cc52-4f1f-8ddb-06c54d577ce2 | 2024-03-01 | Warnings | M012 |
| APRODINE | PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL | A-S Medication Solutions | bbc268b8-fa66-4dc5-b935-f77ae39d28c8 | 2024-02-29 | Warnings | M012 |
| XtraCare Vaporizing Chest Rub | CAMPHOR, MENTHOL | Rejoice International | c3e220d6-fff4-452f-99a9-bd701fc608a0 | 2024-02-28 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime Berry Burst | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | ebbb2f4b-ba84-40ad-96f6-60225119a33b | 2024-02-27 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AMERISOURCE BERGEN | 1c93c45d-1141-4599-83ba-6d3b38f9ffc4 | 2024-02-23 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 3dc293c9-736b-4bd8-b993-ff83b9909bcd | 2024-02-23 | Warnings | M012 |
| Childrens Dibromm Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Cardinal Health (Leader) 70000 | 10cc7d67-30c4-4451-bf74-78abae3c8e25 | 2024-02-23 | Warnings | M012 |
| Nasal Spray, 24-7 for Life | OXYMETAZOLINE HYDROCHLORIDE 0.05% | Lil' Drug Store Products, Inc. | 11d27c75-fd95-f9da-e063-6394a90ac6b0 | 2024-02-20 | Warnings | M012 |
| Nighttime Cold and Cough childrens | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Best Choice (Valu Merchandisers Company) | 11652e8a-2242-4449-8a41-a8e75509025e | 2024-02-20 | Warnings | M012 |
| Severe Sinus Relief Mist | OXYMETAZOLINE SPRAY | Walgreens Company | 847f47d9-62b1-49a3-8bb3-9bf275685bd2 | 2024-02-14 | 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 |