NDC 0591-0493-01 - Mexiletine HCl

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: 0591-0493
Requested NDC: 0591-0493-01
Package NDCs from labels: 0591-0493-01, 0591-0493-05
Manufacturer: Watson Laboratories, Inc.
Effective date: 2008-04-29
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Mexiletine Hydrochloride Capsules USP Rx only	Watson Laboratories, Inc.	2008-04-29	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-0493-01	Mexiletine HCl	100 in 1 BOTTLE	CAPSULE	100		2
0591-0493-05	Mexiletine HCl	500 in 1 BOTTLE	CAPSULE	500		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-0493	MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2	2 package rows	20080521_AB73778B-6794-441C-B127-610A6D0733EA.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Mexiletine hydrochloride	ACTIVE INGREDIENT	606D60IS38	MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
Mexiletine	ACTIVE MOIETY	1U511HHV4Z	MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
black iron oxide	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
colloidal silicon dioxide	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
corn starch	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
D & C Red No. 28	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
D & C Yellow No. 10	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
FD & C Blue No. 1	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
FD & C Green No. 3	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
FD & C Red No. 40	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
gelatin	INACTIVE INGREDIENT	2G86QN327L	MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
pregelatinized starch	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
red iron oxide	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2
yellow iron oxide	INACTIVE INGREDIENT		MEXILETINE HCL (MEXILETINE HYDROCHLORIDE) CAPSULE [WATSON LABORATORIES, INC.]	2

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 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	1c6024e9-760b-40a4-9ef1-b75b269c582a	2026-08-11	Warnings, Adverse reactions	Exact identifier rxcui: 1362706
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Amerisyn LLC	58b7a7f5-5ae0-2f60-e063-6394a90a37dd	2026-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1362706 rxcui: 1362712 rxcui: 1362720
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	a61a07f6-0b48-4dcd-ad42-5d90f6e69ab1	2026-05-14	Warnings, Adverse reactions	Exact identifier rxcui: 1362706 rxcui: 1362712 rxcui: 1362720
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	c09f68fa-759e-4772-9f6b-11005d8f83d5	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1362706
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	9c2e1055-2fa1-462c-90f3-6d77e89ea38a	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1362706
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	b1cb1e35-9586-41c4-b43f-c517f2d42f31	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1362712
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	8b192b46-e69f-4031-b843-8b28fa85f07b	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1362720
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	a0bd3f2c-44e5-4ad0-9b76-c2028f0cae11	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1362712
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	e2c0430d-35ee-460c-b0d5-f117d43430c5	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1362720
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	AvKARE	c528aae3-ff51-b9e4-a401-4ef5910e4b43	2026-01-15	Boxed warning, Adverse reactions	Exact identifier rxcui: 1362706 rxcui: 1362712 rxcui: 1362720
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Chartwell RX, LLC	4e03e02f-c516-479e-9126-86b0df7f8b1c	2025-12-17	Boxed warning, Adverse reactions	Exact identifier rxcui: 1362720
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	bfe2b847-e18d-cef2-e053-2995a90a42af	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1362706 rxcui: 1362712 rxcui: 1362720
Mexiletine hydrochloride	MEXILETINE HYDROCHLORIDE	American Health Packaging	9d0b5d78-63dc-4208-b590-0789d3ed5785	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1362706
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	1b3a807f-368a-42dc-8266-ddf8347a8826	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1362706 rxcui: 1362712 rxcui: 1362720
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	3aec79aa-9dfb-495f-9280-2b830dc7eae9	2025-11-06	Warnings, Adverse reactions	Exact identifier rxcui: 1362706
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	68987377-c7c2-493b-be42-30379ec432bc	2025-11-06	Warnings, Adverse reactions	Exact identifier rxcui: 1362712
Mexiletine Hydrochloride	MEXILETINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	17c65cba-f56f-4cad-a9e2-d31f62e95849	2025-02-05	Warnings, Adverse reactions	Exact identifier rxcui: 1362706 rxcui: 1362712 rxcui: 1362720
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	0ff45dbf-b555-4f55-a286-98bfaea9ea29	2024-10-18	Warnings, Adverse reactions	Exact identifier rxcui: 1362720
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	6cd564bd-24e3-481b-b998-f69f65d67fbe	2024-08-08	Warnings, Adverse reactions	Exact identifier rxcui: 1362706
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	Bryant Ranch Prepack	2f4239ef-a28a-40d3-9617-2029d492829d	2024-05-31	Warnings, Adverse reactions	Exact identifier rxcui: 1362712

Reported adverse events (FAERS/openFDA)#

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