Meclizine Hydrochloride

Product NDC
0536-1299
11-digit product format
005361299
Labeler code
0536
Product ID
0536-1299_0eafa87d-ba74-5faa-e063-6294a90a79c1
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Rugby Laboratories
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

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

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
b57f14a7-3852-03db-e053-2a95a90a80d6Available 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
0536-1299-01Meclizine Hydrochloride100 in 1 BOTTLETABLET, CHEWABLE1003
0536-1299-10Meclizine Hydrochloride1000 in 1 BOTTLETABLET, CHEWABLE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1299-10EA - Each0536-12994be88e27-d239-44c2-93e3-eb1867badd8212021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1299MECLIZINE HYDROCHLORIDE TABLET, CHEWABLE [RUGBY LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20240112_b57f14a7-3852-03db-e053-2a95a90a80d6.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 · 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
ndc (product): 0536-1299
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 TabletPSNcd82fca9-a8dc-4545-8e64-b67d644832e7103
995632meclizine hydrochloride 25 MG Chewable TabletSCDcd82fca9-a8dc-4545-8e64-b67d644832e7103
995632meclizine HCl 25 MG Chewable TabletPSNf2390098-efb7-4cfb-879b-fe4524daf8869
995632meclizine hydrochloride 25 MG Chewable TabletSCDf2390098-efb7-4cfb-879b-fe4524daf8869
995632meclizine HCl 25 MG Chewable TabletPSNd0d8b376-8fe9-8776-e053-2a95a90ae6516
995632meclizine HCl 25 MG Chewable TabletPSN2518b0b6-35ab-49f4-936c-1eafea04b4666
995632meclizine HCl 25 MG Chewable TabletPSNa9ad5d27-306d-48ca-a10d-0a0415d08f056
995632meclizine hydrochloride 25 MG Chewable TabletSCDa9ad5d27-306d-48ca-a10d-0a0415d08f056
995632meclizine hydrochloride 25 MG Chewable TabletSCDd0d8b376-8fe9-8776-e053-2a95a90ae6516
995632meclizine hydrochloride 25 MG Chewable TabletSCD2518b0b6-35ab-49f4-936c-1eafea04b4666
995632meclizine HCl 25 MG Chewable TabletPSN54731aaf-d413-4976-b040-40c8e3e7eafd5
995632meclizine hydrochloride 25 MG Chewable TabletSCD54731aaf-d413-4976-b040-40c8e3e7eafd5
995632meclizine HCl 25 MG Chewable TabletPSNb57f14a7-3852-03db-e053-2a95a90a80d63
995632meclizine hydrochloride 25 MG Chewable TabletSCDb57f14a7-3852-03db-e053-2a95a90a80d63
995632meclizine HCl 25 MG Chewable TabletPSN199ae195-4556-ee88-e063-6394a90a40d42
995632meclizine hydrochloride 25 MG Chewable TabletSCD199ae195-4556-ee88-e063-6394a90a40d42
995632meclizine HCl 25 MG Chewable TabletPSNf41ea190-d73d-b8de-e053-2a95a90a076f1
995632meclizine HCl 25 MG Chewable TabletPSN0a10016e-3fca-476d-b815-fd2abd6019181
995632meclizine hydrochloride 25 MG Chewable TabletSCDf41ea190-d73d-b8de-e053-2a95a90a076f1
995632meclizine hydrochloride 25 MG Chewable TabletSCD0a10016e-3fca-476d-b815-fd2abd6019181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1299-0100536129901100 TABLET, CHEWABLE in 1 BOTTLE (0536-1299-01) 2020-10-300000-00-00NoNoCurrent
0536-1299-10005361299101000 TABLET, CHEWABLE in 1 BOTTLE (0536-1299-10) 2020-11-090000-00-00NoNoCurrent