FDA.reportPublic FDA data

NDC 80425-0494-01 - Meclizine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0494
Requested NDC
80425-0494-01
Package NDCs from labels
80425-0494-3, 80425-0494-1, 80425-0494-2, 80425-0494-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-02-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Meclizine Hydrochloride - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-02-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0494-1Meclizine Hydrochloride30 in 1 BOTTLETABLET301
80425-0494-2Meclizine Hydrochloride60 in 1 BOTTLETABLET601
80425-0494-3Meclizine Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0494MECLIZINE HYDROCHLORIDE TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20250204_2d31ae73-3f09-a77c-e063-6294a90ade9a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0494-1EA - Each80425-0494136b1cfe-6b9a-4575-ad52-3dc754d4b79e12025-03-04
80425-0494-2EA - Each80425-0494c7014f6b-dbea-4409-80b9-b08cfcb407ef12025-03-04
80425-0494-3EA - Each80425-0494105c9b1a-21dc-4e1e-b082-5b28915344c012025-03-04

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 3 of 19 · 373 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacyc6b3f4d8-5fcf-2278-e053-2a95a90ab1392026-06-21Warnings, Adverse reactionsExact identifier
application number: NDA010721
rxcui: 995666
unii: HDP7W44CIO
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Motion Sickness ReliefMECLIZINE HCLCardinal Health 110, LLC. DBA Leader69099658-a584-49a9-8a95-de258a697c4f2026-06-16WarningsExact identifier
rxcui: 995666
unii: HDP7W44CIO
Motion SicknessMECLIZINE HCLARMY AND AIR FORCE EXCHANGE SERVICE20229ad5-cb28-4667-ab70-97a1102873a22026-06-16WarningsExact identifier
rxcui: 995666
unii: HDP7W44CIO
Meclizine HCL 25 mgMECLIZINE HCLPreferred Pharmaceuticals Inc.e4201bdc-18b4-4229-a7c0-300c5d5ad8db2026-06-12WarningsExact identifier
rxcui: 995632
unii: HDP7W44CIO
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.d7d31433-8f39-4fe6-b542-1b4410122db72026-06-12Warnings, Adverse reactionsExact identifier
application number: NDA010721
rxcui: 995624
unii: HDP7W44CIO
Meclizine HClMECLIZINE HYDROCHLORIDE CHEWABLEPreferred Pharmaceuticals Inc.a7f3f32a-0651-4e55-ac51-c85a23352a242026-06-12WarningsExact identifier
rxcui: 995632
unii: HDP7W44CIO
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDERedpharm Drug53df5b1b-64da-e805-e063-6294a90a0a552026-06-10Warnings, Adverse reactionsExact identifier
rxcui: 995666
unii: HDP7W44CIO
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
MECLIZINE HYDROCHLORIDEMECLIZINEBryant Ranch Prepack1079db3f-d8ad-4c25-aa91-8ac8054ee4f22026-06-08Warnings, Adverse reactionsExact identifier
rxcui: 995624
unii: HDP7W44CIO
MECLIZINE HYDROCHLORIDEMECLIZINERedpharm Drug52ee9258-8311-e6bd-e063-6294a90a567f2026-05-29Warnings, Adverse reactionsExact identifier
rxcui: 995624
unii: HDP7W44CIO
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepack81e1762b-e012-4c6d-96e6-9a9f27a1880a2026-05-27Warnings, Adverse reactionsExact identifier
application number: NDA010721
rxcui: 995624
unii: HDP7W44CIO
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEMajor Pharmaceuticalsf99f13ab-33c0-4304-8dc5-3a75f39093772026-05-26Warnings, Adverse reactionsExact identifier
rxcui: 995624
rxcui: 995666
unii: HDP7W44CIO
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Motion Sickness ReliefMECLIZINE HCLWalgreen Company761b7f9d-eaa1-47f0-89d9-c2da0e364a8b2026-05-18WarningsExact identifier
rxcui: 995632
unii: HDP7W44CIO
Motion SicknessMECLIZINE HCLStrategic Sourcing Services LLC550b803c-a038-455c-908a-a6244c0952ba2026-05-12WarningsExact identifier
rxcui: 995632
unii: HDP7W44CIO
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEQPharma Inc2df6edde-4479-ed9d-e063-6394a90abdc12026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 995666
unii: HDP7W44CIO

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.