FDA.reportPublic FDA data

Motion Sickness Relief

Product NDC
50844-403
Requested package NDC
50844-403-19
11-digit product format
508440403
Labeler code
50844
Product ID
50844-403_9efc1a97-585a-4c02-9ac9-b22ffe4eebfc
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-06-24
Marketing end
2026-10-31
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Motion Sickness Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HDP7W44CIOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995666Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8e1889de-fbef-44f1-bbfb-c68a78e6330cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50844-403-19Motion Sickness Relief8 in 1 BLISTER PACKTABLET815
50844-403-19Motion Sickness Relief1 in 1 CARTONTABLET115

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]2
MECLIZINEACTIVE MOIETY3L5TQ84570MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-403MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]14Current NDC, Legacy NDC, 2 package rows20240711_8e1889de-fbef-44f1-bbfb-c68a78e6330c.zip

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 6 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Airmit AceDIMENHYDRINATESato Pharmaceutical Co., Ltd.a98d252d-4cfa-496a-ab2c-627f45f0d7d92023-12-01WarningsExact identifier
application number: M009
Meclizine HClMECLIZINE HYDROCHLORIDEBluePoint Laboratoriesd9cae5a6-8d4b-bdaf-e053-2995a90a7d442023-11-17WarningsExact identifier
application number: M009
ZenTrip Motion SicknessMECLIZINE HYDROCHLORIDESato Pharmaceutical Co., LTDbd86c4c7-b6f0-e3e8-e053-2995a90a44542023-11-03WarningsExact identifier
application number: M009
Travel-EaseMECLIZINE HCLGeri-Care Pharmaceutical Corpe3c64eb9-4972-29d9-e053-2a95a90a2a8a2023-10-25WarningsExact identifier
application number: M009
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d95240bb-02f2-3226-e053-2995a90afacd2022-03-03WarningsExact identifier
application number: M009
Allergy DyeFreeALLERGY DYEFREEAllegiant Health15736bb8-5a5b-489d-83ad-4cf34ec629562021-04-26WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATE 50MGAllegiant Health7b0aa993-f08f-4dff-a82d-f35b3ebe3cc12019-12-12WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN8e1889de-fbef-44f1-bbfb-c68a78e6330c15
995666meclizine hydrochloride 25 MG Oral TabletSCD8e1889de-fbef-44f1-bbfb-c68a78e6330c15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-403-19508440403191 BLISTER PACK in 1 CARTON (50844-403-19) / 8 TABLET in 1 BLISTER PACK1 blister pack2002-06-242026-10-31NoNoCurrent