FDA.reportPublic FDA data

Mexiletine HCl

Manufacturer
AX Pharmaceutical Corp
Effective date
2025-05-12
Label type
BULK INGREDIENT - ANIMAL DRUG
Version
1
Source
full-release
Hydrated at
2026-06-01 02:51:37

Label at a glance#

ProductMexiletine HCl
Active ingredientMEXILETINE HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

Mexiletine HCl

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
497452b0-11f5-0347-7928-e7d06bb38077Product name420230426

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73377-323-01Mexiletine HCl500 g in 1 JARPOWDER5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73377-323MEXILETINE HCL POWDER [AX PHARMACEUTICAL CORP]11 package rows20250514_b635fe28-11a7-4ea4-85d5-54d8b3aa896f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73377-32373377-323-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEXILETINE HYDROCHLORIDE606D60IS38ACTIB

Source Document#

Source XML

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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEBryant Ranch Prepack1c6024e9-760b-40a4-9ef1-b75b269c582a2026-08-11Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEAmerisyn LLC58b7a7f5-5ae0-2f60-e063-6394a90a37dd2026-08-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEMacleods Pharmaceuticals Limiteda61a07f6-0b48-4dcd-ad42-5d90f6e69ab12026-05-14Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEBryant Ranch Prepackc09f68fa-759e-4772-9f6b-11005d8f83d52026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEBryant Ranch Prepack9c2e1055-2fa1-462c-90f3-6d77e89ea38a2026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEBryant Ranch Prepackb1cb1e35-9586-41c4-b43f-c517f2d42f312026-03-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEBryant Ranch Prepack8b192b46-e69f-4031-b843-8b28fa85f07b2026-03-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEBryant Ranch Prepacka0bd3f2c-44e5-4ad0-9b76-c2028f0cae112026-03-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEBryant Ranch Prepacke2c0430d-35ee-460c-b0d5-f117d43430c52026-03-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEAvKAREc528aae3-ff51-b9e4-a401-4ef5910e4b432026-01-15Boxed warning, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEChartwell RX, LLC4e03e02f-c516-479e-9126-86b0df7f8b1c2025-12-17Boxed warning, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEGolden State Medical Supply, Inc.bfe2b847-e18d-cef2-e053-2995a90a42af2025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
Mexiletine hydrochlorideMEXILETINE HYDROCHLORIDEAmerican Health Packaging9d0b5d78-63dc-4208-b590-0789d3ed57852025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDEANI Pharmaceuticals, Inc.1b3a807f-368a-42dc-8266-ddf8347a88262025-11-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEBryant Ranch Prepack3aec79aa-9dfb-495f-9280-2b830dc7eae92025-11-06Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEBryant Ranch Prepack68987377-c7c2-493b-be42-30379ec432bc2025-11-06Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
Mexiletine HydrochlorideMEXILETINE HYDROCHLORIDERising Pharma Holdings, Inc.17c65cba-f56f-4cad-a9e2-d31f62e958492025-02-05Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEBryant Ranch Prepack0ff45dbf-b555-4f55-a286-98bfaea9ea292024-10-18Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEBryant Ranch Prepack6cd564bd-24e3-481b-b998-f69f65d67fbe2024-08-08Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE
MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDEBryant Ranch Prepack2f4239ef-a28a-40d3-9617-2029d492829d2024-05-31Warnings, Adverse reactionsName fallback
generic name: MEXILETINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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