FDA.reportPublic FDA data

Motion Sickness Relief

Product NDC
51013-322
11-digit product format
510130322
Labeler code
51013
Product ID
51013-322_116d1b6a-03af-4b3c-a81a-e1a598bf4f6b
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
PuraCap Pharmaceutical LLC
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-11-28
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Motion Sickness ReliefMECLIZINE HCLPuraCap Pharmaceutical LLC8d772ff0-1476-48ca-a7e4-9473ce3db83a2017-11-28WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use for children under 12 years of age unless directed by a doctor Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Motion Sickness Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995632

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-322-54Motion Sickness Relief15 in 1 CARTONTABLET, CHEWABLE151
51013-322-54Motion Sickness Relief2 in 1 POUCHTABLET, CHEWABLE21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-322MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET, CHEWABLE [PURACAP PHARMACEUTICAL LLC]1Current NDC, Legacy NDC, 2 package rows20171129_8d772ff0-1476-48ca-a7e4-9473ce3db83a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSN8d772ff0-1476-48ca-a7e4-9473ce3db83a1
995632meclizine hydrochloride 25 MG Chewable TabletSCD8d772ff0-1476-48ca-a7e4-9473ce3db83a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51013-322-545101303225415 POUCH in 1 CARTON (51013-322-54) / 2 TABLET, CHEWABLE in 1 POUCH15 pouch2017-11-280000-00-00NoNoCurrent