FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
50090-5952
11-digit product format
500905952
Labeler code
50090
Product ID
50090-5952_e381dd5a-27d4-4468-93a6-55226903b9d6
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
A-S Medication Solutions
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-30
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
Meclizine Hydrochloride
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
50090-5952-0Meclizine Hydrochloride30 in 1 BOTTLETABLET, CHEWABLE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5952-0EA - Each50090-5952a3d7e285-5a57-4e55-ad89-8d581e114db112024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5952MECLIZINE HYDROCHLORIDE TABLET, CHEWABLE [A-S MEDICATION SOLUTIONS]9Current NDC, 1 package rows20240731_f2390098-efb7-4cfb-879b-fe4524daf886.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 1 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dramamine OrangeDIMENHYDRINATEMedtech Products Inc.76166156-bce1-492f-833e-6bbd07859c3f2026-09-17WarningsExact identifier
application number: M009
Pepto Nausea Motion SicknessMECLIZINE HCLTHE PROCTER & GAMBLE MANUFACTURING COMPANY29a1bd1e-d0e0-478f-e063-6394a90ab0aa2026-09-10WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEA-S Medication Solutions2518b0b6-35ab-49f4-936c-1eafea04b4662026-09-09WarningsExact identifier
application number: M009
Dramamine Less DrowsyMECLIZINE HYDROCHLORIDEMedtech Products Inc.fa6a0969-7427-4b87-bc04-a2792665c2182026-09-04WarningsExact identifier
application number: M009
Less Drowsy Motion Sickness ReliefMECLIZINE HCLWal-Mart Stores Inc277a6266-e641-4621-bbb9-64195d51b66a2026-08-28WarningsExact identifier
application number: M009
Nausea ReliefMECLIZINE HCLWALMART INC.8010741e-61b2-4c1f-9f0e-21612878fa0e2026-08-28WarningsExact identifier
application number: M009
Motion SicknessMECLIZINE HCLH E B9837e9af-c542-4c0f-be33-94927d67c6a72026-08-21WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepackcd82fca9-a8dc-4545-8e64-b67d644832e72026-08-20WarningsExact identifier
application number: M009
Motion SicknessDIMENHYDRINATEStrategic Sourcing Services LLCbe8f91d4-6e4f-4d47-93e9-7fb91160b7df2026-08-17WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEWalgreen Companyace7eba4-e033-48f5-8533-c3ea9dfc32b02026-08-12WarningsExact identifier
application number: M009
Motion SicknessMECLIZINE HCLStrategic Sourcing Services LLC76fb6471-09b0-4c51-bacc-b3533b6aa9712026-08-07WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATECardinal Health 110, LLC. DBA Leaderce83a868-bdd8-4c77-9bc0-664133028f752026-08-06WarningsExact identifier
application number: M009
Less Drowsy Formula Motion Sickness ReliefMECLIZINE HCLSalado Sales, Inc.273235b0-dacc-4a95-91be-91e13a2c6d102026-08-05WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLL.N.K. International, Inc.8e1889de-fbef-44f1-bbfb-c68a78e6330c2026-07-30WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEChain Drug Marketing Association, Inc.00a327c6-6b86-4702-8c04-55c405c1404c2026-07-23WarningsExact identifier
application number: M009
Pepto Motion SicknessMECLIZINE HCLTHE PROCTER & GAMBLE MANUFACTURING COMPANY571e3eeb-ae9e-7054-e063-6394a90a26342026-07-21WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDERugby Laboratoriesb57f14a7-3852-03db-e053-2a95a90a80d62026-07-16WarningsExact identifier
application number: M009
Motion SicknessDIMENHYDRINATECVS Pharmacy0998947c-cfba-497e-bf7a-9c7f8fff17642026-07-16WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLTopco Associates, LLC307e3144-3b01-4bd0-9155-6b58fc4cab922026-07-09WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEL.N.K. International, Inc.95aae32f-6b3f-469d-86a5-c201a53f862a2026-06-29WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSNf2390098-efb7-4cfb-879b-fe4524daf8869
995632meclizine hydrochloride 25 MG Chewable TabletSCDf2390098-efb7-4cfb-879b-fe4524daf8869

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-5952-05009059520030 TABLET, CHEWABLE in 1 BOTTLE (50090-5952-0) 2022-04-04NoNoCurrent