FDA.reportPublic FDA data

DRAMAMINE

Product NDC
63029-914
11-digit product format
630290914
Labeler code
63029
Product ID
63029-914_46c83b4e-9f3a-4c67-a759-864e16c5506a
Type
HUMAN OTC DRUG
Nonproprietary name
MECLIZINE HYDROCHLORIDE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Medtech Products Inc.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-02
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
DRAMAMINE
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995632Internal RxNorm lookup
2176732Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fdcbcc4e-9370-4975-8905-1f12c73fdc8cAvailable 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
63029-914-12DRAMAMINE1 in 1 BOXTABLET, CHEWABLE11
63029-914-12DRAMAMINE12 in 1 BLISTER PACKTABLET, CHEWABLE121

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 2 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 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
Meclizine HCL 12.5 mgMECLIZINE HCL 12.5 MGProficient Rx LP3ffa63f2-ea06-4be0-9f59-162c2a9604fc2026-04-01WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLMeijer Distribution Inc1ac451c4-2467-46d6-bc0d-f6368699d1682026-03-23WarningsExact identifier
application number: M009
Travel easeMECLIZINE HCLChain Drug Marketing Association, Inc.c1345a46-51f4-4a6e-aa55-05d221e328372026-03-10WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLAmerisource Bergen71654e2b-a4db-4131-8c51-bedb3995784c2026-03-10WarningsExact identifier
application number: M009
Medique Medi-MeclizineMECLIZINE HCLSportpharm LLC95da2a1e-354c-4851-b147-cf6ee52e14e32026-03-03WarningsExact identifier
application number: M009
Motion SicknessDIMENHYDRINATETarget Corporation3fd4a96f-8f69-42bf-b777-6e3a2bfea2752026-03-03WarningsExact identifier
application number: M009
Motion Sickness Relief Less DrowsyMECLIZINE HCLBetter Living Brands, LLCeff22da8-63b2-47b7-8cfc-e8251029ee442026-02-27WarningsExact identifier
application number: M009
DimenhydrinateDIMENHYDRINATELEADER/ Cardinal Health 110, Inc.7c4adbdb-9bce-0c9c-e053-2a91aa0a81072026-02-20WarningsExact identifier
application number: M009
Dramamine Less DrowsyMECLIZINE HYDROCHLORIDENavajo Manufacturing Company Inc.4b203479-ba8d-7237-e063-6294a90ae6cb2026-02-18WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2176732Dramamine Less Drowsy 25 MG Chewable TabletPSNfdcbcc4e-9370-4975-8905-1f12c73fdc8c1
995632meclizine HCl 25 MG Chewable TabletPSNfdcbcc4e-9370-4975-8905-1f12c73fdc8c1
2176732meclizine hydrochloride 25 MG Chewable Tablet [Dramamine Less Drowsy]SBDfdcbcc4e-9370-4975-8905-1f12c73fdc8c1
995632meclizine hydrochloride 25 MG Chewable TabletSCDfdcbcc4e-9370-4975-8905-1f12c73fdc8c1
2176732Dramamine Less Drowsy 25 MG Chewable TabletSYfdcbcc4e-9370-4975-8905-1f12c73fdc8c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63029-914-12630290914121 BLISTER PACK in 1 BOX (63029-914-12) / 12 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2026-02-02NoNoCurrent