Home NDC 57237-333 Meclizine HCl
Product NDC 57237-333
11-digit product format 572370333
Labeler code 57237
Product ID 57237-333_f603203c-84a4-4b41-a244-cff913e5c2e0
Type HUMAN OTC DRUG
Nonproprietary name MECLIZINE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application M009.50
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-22
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 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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57237-333-01 Meclizine HCl 100 in 1 BOTTLE TABLET 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57237-333 MECLIZINE HCL (MECLIZINE HYDROCHLORIDE) TABLET [RISING PHARMA HOLDINGS, INC.] 3 Current NDC, 1 package rows 20241116_acdf636c-66f1-4a1f-87a8-786f51d75708.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 1 · 1 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 57237-333-01 57237033301 100 TABLET in 1 BOTTLE (57237-333-01) 100 tablet 2024-07-22 No No Current