FDA.reportPublic FDA data

ZenTrip Motion Sickness

Product NDC
49873-805
11-digit product format
498730805
Labeler code
49873
Product ID
49873-805_0949e5cb-b9e4-cee1-e063-6394a90a5377
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sato Pharmaceutical Co., LTD
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-01
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

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
ZenTrip Motion Sickness
Listing expiration
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1663815Internal RxNorm lookup
2540687Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bd86c4c7-b6f0-e3e8-e053-2995a90a4454Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49873-805-012023-04-14C16284748780-1f386c64a-3393-0266-e053-dadaa90a7c1aZenTrip Motion Sickness (12 Tablets - 25mg each)
49873-805-012023-01-30C16284748780-1f386c64a-3393-0266-e053-dadaa90a7c1aZenTrip Motion Sickness (12 Tablets - 25mg each)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-805-01ZenTrip Motion Sickness2 in 1 BOXTABLET23
49873-805-01ZenTrip Motion Sickness6 in 1 BLISTER PACKTABLET63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-805ZENTRIP MOTION SICKNESS (MECLIZINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD]3Current NDC, Legacy NDC, 2 package rows20231104_bd86c4c7-b6f0-e3e8-e053-2995a90a4454.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
ndc (product): 49873-805
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
1663815meclizine HCl 25 MG Disintegrating Oral TabletPSNbd86c4c7-b6f0-e3e8-e053-2995a90a44543
2540687ZenTrip 25 MG Disintegrating Oral TabletPSNbd86c4c7-b6f0-e3e8-e053-2995a90a44543
2540687meclizine hydrochloride 25 MG Disintegrating Oral Tablet [Zentrip]SBDbd86c4c7-b6f0-e3e8-e053-2995a90a44543
1663815meclizine hydrochloride 25 MG Disintegrating Oral TabletSCDbd86c4c7-b6f0-e3e8-e053-2995a90a44543
1663815meclizine HCl 25 MG Disintegrating Oral TabletSYbd86c4c7-b6f0-e3e8-e053-2995a90a44543
2540687Zentrip 25 MG Disintegrating Oral TabletSYbd86c4c7-b6f0-e3e8-e053-2995a90a44543

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-805-01498730805012 BLISTER PACK in 1 BOX (49873-805-01) / 6 TABLET in 1 BLISTER PACK2 blister pack2021-05-010000-00-00NoNoCurrent