Home NDC 71610-528 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 table Ingredient Strength MECLIZINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HDP7W44CIO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 995632 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table 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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table 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.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table 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