Home NDC 36800-943-19 Motion Sickness Relief
Product NDC 36800-943
Requested package NDC 36800-943-19
11-digit product format 368000943
Labeler code 36800
Product ID 36800-943_c56d3a54-9383-4b4f-9a55-c6041a3d7d1d
Type HUMAN OTC DRUG
Nonproprietary name Meclizine HCl
Dosage form TABLET
Route ORAL
Labeler Topco Associates, LLC
Application M009
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-05-30
Substance MECLIZINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 2027-12-31 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 36800-943-19 Motion Sickness Relief 8 in 1 BLISTER PACK TABLET 8 10 36800-943-19 Motion Sickness Relief 1 in 1 CARTON TABLET 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-943 MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [TOPCO ASSOCIATES, LLC] 9 Current NDC, Legacy NDC, 2 package rows 20240711_307e3144-3b01-4bd0-9155-6b58fc4cab92.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 1 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 36800-943-19 36800094319 1 BLISTER PACK in 1 CARTON (36800-943-19) / 8 TABLET in 1 BLISTER PACK 1 blister pack 2019-05-30 0000-00-00 No No Current