FDA.reportPublic FDA data

Motion Sickness

Product NDC
51316-441
11-digit product format
513160441
Labeler code
51316
Product ID
51316-441_d6cd6122-3237-41b6-903a-ca8f8306d8f0
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-26
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE25 mg/1

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
51316-441-21Motion Sickness2 in 1 CARTONTABLET, CHEWABLE22
51316-441-21Motion Sickness8 in 1 BLISTER PACKTABLET, CHEWABLE82

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 3 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.d0d8b376-8fe9-8776-e053-2a95a90ae6512026-01-27WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4f806804-48c7-414e-a177-5d3daf5b22e32026-01-20WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLUnited Natural Foods, Inc. dba UNFI108bb943-529f-4510-b770-b54eca493ae02026-01-12WarningsExact identifier
application number: M009
Less Drowsy Motion Sickness ReliefMECLIZINE HCLRite Aid Corporation2f9ebe6b-ffde-41de-9eaa-b03d87d330052026-01-09WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATERite Aid Corporation4f532984-aeee-4dde-972c-742bdf12868f2026-01-07WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLFamily Dollar Services Ince34126e3-52ef-4999-bf61-cba9b18182592026-01-05WarningsExact identifier
application number: M009
CVS Motion Sickness Fast MeltingMECLIZINE HYDROCHLORIDECVS Pharmacy, Inc.2a723bce-a581-4558-b028-22f1f9125dd52025-12-30WarningsExact identifier
application number: M009
Wal-Dram 2 Quick-DissolvingMECLIZINE HYDROCHLORIDEWalgreen Co.f3116203-1b8f-438a-b779-7bdd90eaf79e2025-12-30WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5 MGPharbest Pharmaceuticals, Inc.8b3c9283-b618-4d57-9f15-7cf73e8737f52025-12-24WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 25MGPharbest Pharmaceuticals, Inc.4bac2765-045c-405e-8006-8c5cfdfa89bc2025-12-24WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.fdcbcc4e-9370-4975-8905-1f12c73fdc8c2025-12-23WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.3a960d43-62aa-464e-92b9-d83042ba02bf2025-12-23WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.6efd3473-ee14-4ee0-8a58-d15a64a9224a2025-12-18WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLRite Aid Corporatione599dc64-ac10-4f4e-9318-e9fab05264882025-11-15WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLKroger Company64e0496c-5e09-46e9-94b9-624163d71b602025-11-05WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLWalgreen Company27bd9c74-c85e-4eeb-9e43-4120f90011872025-11-05WarningsExact identifier
application number: M009
Dramamine Original FormulaDIMENHYDRINATEMedtech Products Inc.f9302a5a-295a-4501-9332-e3f5eb3873622025-10-23WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDECVS Pharmacy, Incb57fc6c2-fbfc-24c3-e053-2995a90a33892025-10-16WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLAmerisource Bergen503f62e7-8ec8-4409-9697-4efef4ff7b152025-10-08WarningsExact identifier
application number: M009
Meclizine HCL 25 mgMECLIZINE HCLProficient Rx LPd08fa6f5-4293-4468-814e-7dccbd2812092025-10-01WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSN740a82ec-000a-480e-82bf-1bfb8fd0ff902
995632meclizine hydrochloride 25 MG Chewable TabletSCD740a82ec-000a-480e-82bf-1bfb8fd0ff902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-441-21513160441212 BLISTER PACK in 1 CARTON (51316-441-21) / 8 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2025-09-26NoNoCurrent