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 firm2026-10-15

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 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
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