FDA.reportPublic FDA data

Motion Sickness

Product NDC
55301-403
11-digit product format
553010403
Labeler code
55301
Product ID
55301-403_dea6188b-d8b6-4a05-8229-e902ec373791
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
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
Motion Sickness
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
20229ad5-cb28-4667-ab70-97a1102873a2Available 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
55301-403-21Motion Sickness8 in 1 BLISTER PACKTABLET816
55301-403-21Motion Sickness2 in 1 CARTONTABLET216

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMOTION SICKNESS II (MECLIZINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]2
MECLIZINEACTIVE MOIETY3L5TQ84570MOTION SICKNESS II (MECLIZINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMOTION SICKNESS II (MECLIZINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMOTION SICKNESS II (MECLIZINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MOTION SICKNESS II (MECLIZINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-403MOTION SICKNESS (MECLIZINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]15Current NDC, Legacy NDC, 2 package rows20240622_20229ad5-cb28-4667-ab70-97a1102873a2.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 5 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Motion Sickness ReliefDIMENHYDRINATE 50 MGTARGET CORPORATION28586e9b-01e3-0b88-e063-6394a90af7e02025-01-29WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5MGUlai Health LLCd304e205-85fa-494a-9a68-ae6855b139b12025-01-20WarningsExact identifier
application number: M009
Meclizine HCL 12.5 mgMECLIZINE HCL 12.5 MGReliable 1 Laboratories LLC32832b0f-0b38-27ce-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M009
Meclizine HCL 25 mgMECLIZINE HCLReliable 1 Laboratories LLC32bdd802-16b0-184d-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAPNAR PHARMA LPe4d785a7-a688-3acb-e053-2a95a90a6d2e2025-01-09Boxed warning, WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAPNAR PHARMA LPed43bf21-f3da-245c-e053-2995a90a504c2025-01-09Boxed warning, WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5 MGRUGBY LABORATORIES8a234ce3-eb6b-49dd-9d78-7fc7bdd49d352024-12-20WarningsExact identifier
application number: M009
MeclizineMECLIZINE HYDROCHLORIDEAdvanced Rx LLCb0a2a1f7-354e-48bd-9e98-9207bf9f53fd2024-11-27WarningsExact identifier
application number: M009
Dramamine, TRAVEL BASIXDIMENHYDRINATELil' Drug Store Products, Inc.960a642b-ee7c-4e92-9b5f-930425682dac2024-11-26WarningsExact identifier
application number: M009
Dramamine Less Drowsy, Lil Drug StoreMECLAZINE HYDROCHLORIDE TABLETLil' Drug Store Products, Inc.275b3377-9280-c12c-e063-6294a90a54212024-11-20WarningsExact identifier
application number: M009
PhysiciansCare Motion SicknessMECLIZINE HCLAcme United Corporationc4d3ea22-7c22-7311-e053-2a95a90a779c2024-11-12WarningsExact identifier
application number: M009
DRAMAMINE - NMECLIZINE HYDROCHLORIDEMedtech Products Inc.7fec7791-c242-4e43-8184-32820e657afb2024-10-25WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.f8cf751a-9f19-4744-a350-cd22303435ee2024-10-25WarningsExact identifier
application number: M009
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d955f612-1265-f1be-e053-2995a90a53452024-07-18WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC199ae195-4556-ee88-e063-6394a90a40d42024-06-10WarningsExact identifier
application number: M009
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSN20229ad5-cb28-4667-ab70-97a1102873a216
995666meclizine hydrochloride 25 MG Oral TabletSCD20229ad5-cb28-4667-ab70-97a1102873a216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-403-21553010403212 BLISTER PACK in 1 CARTON (55301-403-21) / 8 TABLET in 1 BLISTER PACK2 blister pack2002-06-240000-00-00NoNoCurrent