MECLIZINE

Product NDC
43063-804
11-digit product format
430630804
Labeler code
43063
Product ID
43063-804_2fb4b0a4-ecff-437f-e063-6394a90a2d5f
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl 25mg
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-01
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
Listing expiration
2026-12-31

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
cf79ac74-017e-4fb4-85d3-4ea944080e89Available 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
43063-804-01MECLIZINE100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE10014
43063-804-06MECLIZINE6 in 1 BOTTLE, PLASTICTABLET, CHEWABLE614
43063-804-12MECLIZINE12 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1214
43063-804-20MECLIZINE20 in 1 BOTTLE, PLASTICTABLET, CHEWABLE2014
43063-804-30MECLIZINE30 in 1 BOTTLE, PLASTICTABLET, CHEWABLE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-804-01EA - Each43063-804f0e47f6b-3f09-43d8-8ce2-771a1846c26812018-03-08
43063-804-12EA - Each43063-804939a1d6b-47bf-4263-a894-09879823b0a312018-01-12
43063-804-20EA - Each43063-8045504be70-097b-4721-ba3c-f1d227ff8cb612018-02-20
43063-804-30EA - Each43063-80416228db3-bdfd-44a7-886f-1f0caf69e7b712018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-804MECLIZINE (MECLIZINE HCL 25MG) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 5 package rows20250313_cf79ac74-017e-4fb4-85d3-4ea944080e89.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
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 TabletPSNcf79ac74-017e-4fb4-85d3-4ea944080e8914
995632meclizine hydrochloride 25 MG Chewable TabletSCDcf79ac74-017e-4fb4-85d3-4ea944080e8914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-804-0143063080401100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-01) 2018-02-182027-11-30NoNoCurrent
43063-804-06430630804066 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-06) 2018-07-232027-11-30NoNoCurrent
43063-804-124306308041212 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-12) 2018-02-012027-11-30NoNoCurrent
43063-804-204306308042020 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-20) 2018-02-012027-11-30NoNoCurrent
43063-804-304306308043030 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-30) 2018-02-012027-11-30NoNoCurrent