FDA.reportPublic FDA data

Dramamine Less Drowsy

Product NDC
63029-903
11-digit product format
630290903
Labeler code
63029
Product ID
63029-903_5aaed2b3-5738-2eaa-e063-6394a90a8f8b
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Medtech Products Inc.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-09-01
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63029-90363029-903-10DDiscontinued by firm2026-10-12

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 Less Drowsy
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
995666Internal RxNorm lookup
995726Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fa6a0969-7427-4b87-bc04-a2792665c218Available 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
63029-903-01Dramamine Less Drowsy8 in 1 BOTTLETABLET86
63029-903-01Dramamine Less Drowsy1 in 1 BLISTER PACKTABLET16
63029-903-04Dramamine Less Drowsy2 in 1 POUCHTABLET26
63029-903-04Dramamine Less Drowsy2 in 1 CARTONTABLET26
63029-903-10Dramamine Less Drowsy2 in 1 CARTONTABLET26
63029-903-10Dramamine Less Drowsy5 in 1 BLISTER PACKTABLET56

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIODRAMAMINE LESS DROWSY (MECLIZINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]2
MECLIZINEACTIVE MOIETY3L5TQ84570DRAMAMINE LESS DROWSY (MECLIZINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DRAMAMINE LESS DROWSY (MECLIZINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDRAMAMINE LESS DROWSY (MECLIZINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDRAMAMINE LESS DROWSY (MECLIZINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DRAMAMINE LESS DROWSY (MECLIZINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDRAMAMINE LESS DROWSY (MECLIZINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DRAMAMINE LESS DROWSY (MECLIZINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDRAMAMINE LESS DROWSY (MECLIZINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-903DRAMAMINE LESS DROWSY (MECLIZINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]5Current NDC, Legacy NDC, 6 package rows20240105_fa6a0969-7427-4b87-bc04-a2792665c218.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 3 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.d0d8b376-8fe9-8776-e053-2a95a90ae6512026-01-27WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4f806804-48c7-414e-a177-5d3daf5b22e32026-01-20WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLUnited Natural Foods, Inc. dba UNFI108bb943-529f-4510-b770-b54eca493ae02026-01-12WarningsExact identifier
application number: M009
Less Drowsy Motion Sickness ReliefMECLIZINE HCLRite Aid Corporation2f9ebe6b-ffde-41de-9eaa-b03d87d330052026-01-09WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATERite Aid Corporation4f532984-aeee-4dde-972c-742bdf12868f2026-01-07WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLFamily Dollar Services Ince34126e3-52ef-4999-bf61-cba9b18182592026-01-05WarningsExact identifier
application number: M009
CVS Motion Sickness Fast MeltingMECLIZINE HYDROCHLORIDECVS Pharmacy, Inc.2a723bce-a581-4558-b028-22f1f9125dd52025-12-30WarningsExact identifier
application number: M009
Wal-Dram 2 Quick-DissolvingMECLIZINE HYDROCHLORIDEWalgreen Co.f3116203-1b8f-438a-b779-7bdd90eaf79e2025-12-30WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5 MGPharbest Pharmaceuticals, Inc.8b3c9283-b618-4d57-9f15-7cf73e8737f52025-12-24WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 25MGPharbest Pharmaceuticals, Inc.4bac2765-045c-405e-8006-8c5cfdfa89bc2025-12-24WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.fdcbcc4e-9370-4975-8905-1f12c73fdc8c2025-12-23WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.3a960d43-62aa-464e-92b9-d83042ba02bf2025-12-23WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.6efd3473-ee14-4ee0-8a58-d15a64a9224a2025-12-18WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLRite Aid Corporatione599dc64-ac10-4f4e-9318-e9fab05264882025-11-15WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLKroger Company64e0496c-5e09-46e9-94b9-624163d71b602025-11-05WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLWalgreen Company27bd9c74-c85e-4eeb-9e43-4120f90011872025-11-05WarningsExact identifier
application number: M009
Dramamine Original FormulaDIMENHYDRINATEMedtech Products Inc.f9302a5a-295a-4501-9332-e3f5eb3873622025-10-23WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDECVS Pharmacy, Incb57fc6c2-fbfc-24c3-e053-2995a90a33892025-10-16WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLAmerisource Bergen503f62e7-8ec8-4409-9697-4efef4ff7b152025-10-08WarningsExact identifier
application number: M009
Meclizine HCL 25 mgMECLIZINE HCLProficient Rx LPd08fa6f5-4293-4468-814e-7dccbd2812092025-10-01WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995726Dramamine Less Drowsy 25 MG Oral TabletPSNfa6a0969-7427-4b87-bc04-a2792665c2186
995666meclizine HCl 25 MG Oral TabletPSNfa6a0969-7427-4b87-bc04-a2792665c2186
995726meclizine hydrochloride 25 MG Oral Tablet [Dramamine Less Drowsy]SBDfa6a0969-7427-4b87-bc04-a2792665c2186
995666meclizine hydrochloride 25 MG Oral TabletSCDfa6a0969-7427-4b87-bc04-a2792665c2186
995726Dramamine II 25 MG Oral TabletSYfa6a0969-7427-4b87-bc04-a2792665c2186
995726Dramamine Less Drowsy 25 MG Oral TabletSYfa6a0969-7427-4b87-bc04-a2792665c2186
995726Dramamine Less Drowsy 25 MG Oral TabletPSN113b2504-a0e9-4fa8-bdcf-31792fbd359c1
995726Dramamine Less Drowsy 25 MG Oral TabletPSN4b203479-ba8d-7237-e063-6294a90ae6cb1
995666meclizine HCl 25 MG Oral TabletPSN113b2504-a0e9-4fa8-bdcf-31792fbd359c1
995666meclizine HCl 25 MG Oral TabletPSN4b203479-ba8d-7237-e063-6294a90ae6cb1
995726meclizine hydrochloride 25 MG Oral Tablet [Dramamine Less Drowsy]SBD113b2504-a0e9-4fa8-bdcf-31792fbd359c1
995726meclizine hydrochloride 25 MG Oral Tablet [Dramamine Less Drowsy]SBD4b203479-ba8d-7237-e063-6294a90ae6cb1
995666meclizine hydrochloride 25 MG Oral TabletSCD4b203479-ba8d-7237-e063-6294a90ae6cb1
995666meclizine hydrochloride 25 MG Oral TabletSCD113b2504-a0e9-4fa8-bdcf-31792fbd359c1
995726Dramamine II 25 MG Oral TabletSY4b203479-ba8d-7237-e063-6294a90ae6cb1
995726Dramamine II 25 MG Oral TabletSY113b2504-a0e9-4fa8-bdcf-31792fbd359c1
995726Dramamine Less Drowsy 25 MG Oral TabletSY4b203479-ba8d-7237-e063-6294a90ae6cb1
995726Dramamine Less Drowsy 25 MG Oral TabletSY113b2504-a0e9-4fa8-bdcf-31792fbd359c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-903-01630290903011 BOTTLE in 1 BLISTER PACK (63029-903-01) / 8 TABLET in 1 BOTTLE1 bottle2011-09-010000-00-00NoNoCurrent
63029-903-04630290903042 POUCH in 1 CARTON (63029-903-04) / 2 TABLET in 1 POUCH2 pouch2026-01-05NoNoCurrent
63029-903-10630290903102 BLISTER PACK in 1 CARTON (63029-903-10) > 5 TABLET in 1 BLISTER PACK2 blister pack2011-09-010000-00-00NoNoCurrent
63029-903-16630290903162 BLISTER PACK in 1 CARTON (63029-903-16) / 8 TABLET in 1 BLISTER PACK2 blister pack2023-12-13NoNoCurrent