FDA.reportPublic FDA data

doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet [Diclegis]

RxCUI
1375954
RxNorm name
doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet [Diclegis]
Display name
doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet [Diclegis]
Full name
doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet [Diclegis]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICLEGISDOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDEDuchesnay USA, Inc.8bde08f6-e8bd-4e90-baa7-82e01876a86a2025-12-03Warnings, Adverse reactionsExact identifier
rxcui: 1375954

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
8bde08f6-e8bd-4e90-baa7-82e01876a86aDiclegis 10 MG / 10 MG Delayed Release Oral Tablet [PSN] · doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet [Diclegis] [SBD] · Diclegis (doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG) Delayed Release Oral Tablet [SY] · doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral Tablet [Diclegis] [SY] · doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral Tablet [Diclegis] [SY]515These highlights do not include all the information needed to use DICLEGIS safely and effectively. See full prescribing information for DICLEGIS. DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets, for oral use. Initial U.S. Approval: 197620251203