Home NDC 83059-0007 Motion Sickness Relief
Product NDC 83059-0007
11-digit product format 830590007
Labeler code 83059
Product ID 83059-0007_458baf7d-dea4-aa22-e063-6394a90a8ae5
Type HUMAN OTC DRUG
Nonproprietary name Meclizine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Shield Pharmaceuticals Corp
Application M002
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-06
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 Motion Sickness Relief
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 995666 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 83059-0007-1 Motion Sickness Relief 15 in 1 BOTTLE TABLET, FILM COATED 15 6 83059-0007-1 Motion Sickness Relief 1 in 1 PACKAGE TABLET, FILM COATED 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83059-0007 MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET, FILM COATED [SHIELD PHARMACEUTICALS CORP] 4 Current NDC, 2 package rows 20241228_9b5ad2ca-a47b-434a-97b5-8f729740d4ee.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 12 of 13 · 242 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83059-0007-1 83059000701 1 BOTTLE in 1 PACKAGE (83059-0007-1) / 15 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2023-12-06 No No Current