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 7 of 19 · 378 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
CVS Motion Sickness Fast MeltingMECLIZINE HYDROCHLORIDECVS Pharmacy, Inc.2a723bce-a581-4558-b028-22f1f9125dd52025-12-30WarningsExact identifier
unii: HDP7W44CIO
Wal-Dram 2 Quick-DissolvingMECLIZINE HYDROCHLORIDEWalgreen Co.f3116203-1b8f-438a-b779-7bdd90eaf79e2025-12-30WarningsExact identifier
unii: HDP7W44CIO
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDERedpharm Drug37457bd5-2fdd-b829-e063-6294a90a04f02025-12-24Warnings, Adverse reactionsExact identifier
rxcui: 995666
unii: HDP7W44CIO
MECLIZINEMECLIZINE HCL 12.5 MGPharbest Pharmaceuticals, Inc.8b3c9283-b618-4d57-9f15-7cf73e8737f52025-12-24WarningsExact identifier
rxcui: 995624
unii: HDP7W44CIO
MECLIZINEMECLIZINE HCL 25MGPharbest Pharmaceuticals, Inc.4bac2765-045c-405e-8006-8c5cfdfa89bc2025-12-24WarningsExact identifier
rxcui: 995632
unii: HDP7W44CIO
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.fdcbcc4e-9370-4975-8905-1f12c73fdc8c2025-12-23WarningsExact identifier
rxcui: 995632
unii: HDP7W44CIO
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.3a960d43-62aa-464e-92b9-d83042ba02bf2025-12-23WarningsExact identifier
rxcui: 995632
unii: HDP7W44CIO
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.6efd3473-ee14-4ee0-8a58-d15a64a9224a2025-12-18WarningsExact identifier
unii: HDP7W44CIO
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Motion Sickness ReliefMECLIZINE HCLShield Pharmaceuticals Corp9b5ad2ca-a47b-434a-97b5-8f729740d4ee2025-12-09WarningsExact identifier
rxcui: 995666
unii: HDP7W44CIO
Meclizine HydroclorideMECLIZINE HYDROCLORIDEQPharma Incaa0fb895-a867-4482-9bc2-16eee8bfaaa02025-12-04Warnings, Adverse reactionsExact identifier
rxcui: 995666
unii: HDP7W44CIO
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEQPharma Inc18fe5e13-5583-45ee-ab6e-32e9af426bd82025-12-03Warnings, Adverse reactionsExact identifier
rxcui: 995666
unii: HDP7W44CIO
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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