FDA.reportPublic FDA data

MECLIZINE

Product NDC
37835-202
11-digit product format
378350202
Labeler code
37835
Product ID
37835-202_48513500-7464-3c2f-e063-6294a90a8b3d
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl 25 mg
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bi-Mart
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-14
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

Additional Listing Data#

Finished product
Yes
Brand name base
MECLIZINE
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
995632Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2e2c8189-c026-48f8-bbc6-371498ccf444Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37835-202-01MECLIZINE100 in 1 BOTTLETABLET, CHEWABLE1001

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 · 117 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Motion Sickness ReliefDIMENHYDRINATECardinal Health 110, LLC. DBA Leaderce83a868-bdd8-4c77-9bc0-664133028f752026-08-06WarningsExact 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
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
DRAMAMINE CHEWABLE ORANGEMECLIZINE HYDROCHLORIDEMedtech Products Inc.30387e63-278d-412a-bcad-7965c7c0aea72026-06-23WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEWal-Mart Stores Incc25a7f2b-0f01-4ec0-8849-f08c23608d1d2026-06-22WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLCardinal Health 110, LLC. DBA Leader69099658-a584-49a9-8a95-de258a697c4f2026-06-16WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATETopco Associates, LLC503a70db-d564-4ea0-851e-8ff617e707282026-06-16WarningsExact identifier
application number: M009
Motion SicknessMECLIZINE HCLARMY AND AIR FORCE EXCHANGE SERVICE20229ad5-cb28-4667-ab70-97a1102873a22026-06-16WarningsExact identifier
application number: M009
Motion SicknessDIMENHYDRINATEGeiss, Destin & Dunn Inc.fdb683c5-ff7f-4b93-9892-670cf1f29f2a2026-06-15WarningsExact identifier
application number: M009
DimenhydrinateDIMENHYDRINATECVS Pharmacy, Inc.6dfc5cb4-af0c-56c9-e053-2a91aa0a5d562026-06-12WarningsExact identifier
application number: M009
DriminateDIMENHYDRINATEMajor Pharmaceuticalsd2967f78-41ee-4c30-8b47-0757df9f3d912026-06-10WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEAmerisource Bergenc4077301-db6c-473d-beb3-232d7134a13a2026-06-03WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLWalgreen Company761b7f9d-eaa1-47f0-89d9-c2da0e364a8b2026-05-18WarningsExact identifier
application number: M009
Motion SicknessMECLIZINE HCLStrategic Sourcing Services LLC550b803c-a038-455c-908a-a6244c0952ba2026-05-12WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEValu Merchandisers Company56c26102-8d39-458e-b076-3fe67456a4c02026-04-16WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLDOLGENCORP, LLC1616c540-dcd9-46f1-823f-27b67ef488d22026-04-16WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSN2e2c8189-c026-48f8-bbc6-371498ccf4441
995632meclizine hydrochloride 25 MG Chewable TabletSCD2e2c8189-c026-48f8-bbc6-371498ccf4441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
37835-202-0137835020201100 TABLET, CHEWABLE in 1 BOTTLE (37835-202-01) 2026-01-14NoNoCurrent