Home NDC 0536-1299-01 Meclizine Hydrochloride
Product NDC 0536-1299
Requested package NDC 0536-1299-01
11-digit product format 005361299
Labeler code 0536
Product ID 0536-1299_56c0ab35-4d8d-1e92-e063-6394a90aa2a7
Type HUMAN OTC DRUG
Nonproprietary name Meclizine Hydrochloride
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Rugby Laboratories
Application M009
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-10-30
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 Meclizine Hydrochloride
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 995632 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 0536-1299-01 Meclizine Hydrochloride 100 in 1 BOTTLE TABLET, CHEWABLE 100 3 0536-1299-10 Meclizine Hydrochloride 1000 in 1 BOTTLE TABLET, CHEWABLE 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-1299 MECLIZINE HYDROCHLORIDE TABLET, CHEWABLE [RUGBY LABORATORIES] 3 Current NDC, Legacy NDC, 2 package rows 20240112_b57f14a7-3852-03db-e053-2a95a90a80d6.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 Marketing start Marketing end Sample Exclude flag Status 0536-1299-01 00536129901 100 TABLET, CHEWABLE in 1 BOTTLE (0536-1299-01) 2020-10-30 0000-00-00 No No Current