Home NDC 73057-386 MECLIZINE
Product NDC 73057-386
11-digit product format 730570386
Labeler code 73057
Product ID 73057-386_2c27a466-defa-b729-e063-6394a90a61d3
Type HUMAN OTC DRUG
Nonproprietary name Meclizine HCl 12.5mg
Dosage form TABLET
Route ORAL
Labeler Ulai Health LLC
Application M009
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-08
Substance MECLIZINE HYDROCHLORIDE
Active strength 12.5 mg/1
Pharmacologic classes Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 73057-386-11 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 73057-386-08 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 73057-386-11 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 73057-386-08 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MECLIZINE HYDROCHLORIDE 12.5 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 995624 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73057-386-08 MECLIZINE 100 in 1 BOTTLE, PLASTIC TABLET 100 3 73057-386-11 MECLIZINE 1000 in 1 BOTTLE, PLASTIC TABLET 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73057-386 MECLIZINE (MECLIZINE HCL 12.5MG) TABLET [ULAI HEALTH LLC] 3 Current NDC, Legacy NDC, 2 package rows 20250122_d304e205-85fa-494a-9a68-ae6855b139b1.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 6 of 6 · 107 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 73057-386-08 73057038608 100 TABLET in 1 BOTTLE, PLASTIC (73057-386-08) 100 tablet 2019-07-08 0000-00-00 No No Current 73057-386-11 73057038611 1000 TABLET in 1 BOTTLE, PLASTIC (73057-386-11) 1000 tablet 2019-07-08 0000-00-00 No No Current