FDA.reportPublic FDA data

Less Drowsy Formula Motion Sickness Relief

Product NDC
57243-403
11-digit product format
572430403
Labeler code
57243
Product ID
57243-403_f6acc0de-27cf-43a1-9bb3-c193f36f04d6
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Salado Sales, Inc.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-06-24
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
Less Drowsy Formula Motion Sickness Relief
Listing expiration
2027-12-31

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 · 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
273235b0-dacc-4a95-91be-91e13a2c6d10Available 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
57243-403-02Less Drowsy Formula Motion Sickness Relief1 in 1 PACKAGETABLET115
57243-403-02Less Drowsy Formula Motion Sickness Relief12 in 1 BOTTLE, PLASTICTABLET1215

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOLESS DROWSY FORMULA MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [SALADO SALES, INC.]3
MECLIZINEACTIVE MOIETY3L5TQ84570LESS DROWSY FORMULA MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [SALADO SALES, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLESS DROWSY FORMULA MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [SALADO SALES, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LESS DROWSY FORMULA MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [SALADO SALES, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLESS DROWSY FORMULA MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [SALADO SALES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57243-403LESS DROWSY FORMULA MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [SALADO SALES, INC.]14Current NDC, Legacy NDC, 2 package rows20240825_273235b0-dacc-4a95-91be-91e13a2c6d10.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 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d941705f-12a1-4757-e053-2995a90ad3fa2024-05-13WarningsExact identifier
application number: M009
Kids Gravol Chewables Motion Sickness DimenhydrinateDIMENHYDRINATEChurch & Dwight Co., Inc.cf6de950-a157-4be2-a302-0dc19511d2f22024-03-01WarningsExact identifier
application number: M009
Gravol Chewables Motion Sickness DimenhydrinateDIMENHYDRINATEChurch & Dwight Co., Inc.de5249f7-79fc-4f3c-965a-1e8ec978a0b72024-03-01WarningsExact identifier
application number: M009
Meclizine HClMECLIZINE HYDROCHLORIDE CHEWABLEBluePoint Laboratoriesd9cc2705-9dcc-0a73-e053-2995a90aafe62024-02-21WarningsExact identifier
application number: M009
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEDeMoulas Market Basketfd04fb94-f581-4ca2-b7ac-20359093863e2023-12-29WarningsExact identifier
application number: M009
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 TabletPSN273235b0-dacc-4a95-91be-91e13a2c6d1015
995666meclizine hydrochloride 25 MG Oral TabletSCD273235b0-dacc-4a95-91be-91e13a2c6d1015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57243-403-02572430403021 BOTTLE, PLASTIC in 1 PACKAGE (57243-403-02) / 12 TABLET in 1 BOTTLE, PLASTIC2002-06-240000-00-00NoNoCurrent