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 1 of 20 · 382 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pepto Nausea Motion SicknessMECLIZINE HCLTHE PROCTER & GAMBLE MANUFACTURING COMPANY29a1bd1e-d0e0-478f-e063-6394a90ab0aa2026-09-10WarningsExact identifier
rxcui: 995666
unii: HDP7W44CIO
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEA-S Medication Solutions2518b0b6-35ab-49f4-936c-1eafea04b4662026-09-09WarningsExact identifier
rxcui: 995632
unii: HDP7W44CIO
Dramamine Less DrowsyMECLIZINE HYDROCHLORIDEMedtech Products Inc.fa6a0969-7427-4b87-bc04-a2792665c2182026-09-04WarningsExact identifier
rxcui: 995666
unii: HDP7W44CIO
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEREMEDYREPACK INC.21d4a6ee-0a66-45d7-bab9-c5eef399713d2026-09-01Warnings, Adverse reactionsExact identifier
application number: NDA010721
rxcui: 995666
unii: HDP7W44CIO
Less Drowsy Motion Sickness ReliefMECLIZINE HCLWal-Mart Stores Inc277a6266-e641-4621-bbb9-64195d51b66a2026-08-28WarningsExact identifier
rxcui: 995666
unii: HDP7W44CIO
Nausea ReliefMECLIZINE HCLWALMART INC.8010741e-61b2-4c1f-9f0e-21612878fa0e2026-08-28WarningsExact identifier
rxcui: 995666
unii: HDP7W44CIO
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDECoupler LLC598eb392-1dfe-c08c-e063-6394a90a4c7d2026-08-21Warnings, Adverse reactionsExact identifier
application number: NDA010721
rxcui: 995666
unii: HDP7W44CIO
Motion SicknessMECLIZINE HCLH E B9837e9af-c542-4c0f-be33-94927d67c6a72026-08-21WarningsExact identifier
rxcui: 995666
unii: HDP7W44CIO
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepackcd82fca9-a8dc-4545-8e64-b67d644832e72026-08-20WarningsExact identifier
rxcui: 995632
unii: HDP7W44CIO
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
Motion SicknessMECLIZINE HCLStrategic Sourcing Services LLC76fb6471-09b0-4c51-bacc-b3533b6aa9712026-08-07WarningsExact identifier
rxcui: 995666
unii: HDP7W44CIO
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Less Drowsy Formula Motion Sickness ReliefMECLIZINE HCLSalado Sales, Inc.273235b0-dacc-4a95-91be-91e13a2c6d102026-08-05WarningsExact identifier
rxcui: 995666
unii: HDP7W44CIO
SurviveX Travel Med MODCONVENIENCE KITIntent Brands LLC522da86b-cfd7-dd20-e063-6394a90a51c62026-08-04WarningsExact identifier
rxcui: 995666
MECLIZINE HYDROCHLORIDEMECLIZINEPreferred Pharmaceuticals Inc.f755f8f3-7645-433c-b502-c1f15b7002992026-08-03Warnings, Adverse reactionsExact identifier
rxcui: 995666
unii: HDP7W44CIO
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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