Home NDC 16103-387 MECLIZINE
Product NDC 16103-387
11-digit product format 161030387
Labeler code 16103
Product ID 16103-387_f25eaba1-2538-4b14-bc67-aa45e07b3014
Type HUMAN OTC DRUG
Nonproprietary name Meclizine HCl 25mg
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Pharbest Pharmaceuticals, Inc.
Application M009
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-02-01
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 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 2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 16103-387-08 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 16103-387-11 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 16103-387-08 bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 16103-387-11 bd6a592717d7…303034d00443…
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 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16103-387-08 MECLIZINE 100 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 100 4 16103-387-11 MECLIZINE 1000 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16103-387 MECLIZINE (MECLIZINE HCL 25MG) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20250101_4bac2765-045c-405e-8006-8c5cfdfa89bc.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 Marketing start Marketing end Sample Exclude flag Status 16103-387-08 16103038708 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16103-387-08) 2018-02-01 0000-00-00 No No Current 16103-387-11 16103038711 1000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16103-387-11) 2018-02-01 0000-00-00 No No Current