FDA.reportPublic FDA data

Meclizine HCL

Product NDC
54738-025
11-digit product format
547380025
Labeler code
54738
Product ID
54738-025_5cc4c45d-5b77-0912-e053-2991aa0a10a5
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl 25mg Chewable Tablets
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Richmond Pharmaceuticals, Inc.
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-05-01
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 HCL
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
98e3fe5a-73c6-4dcc-b397-cc6013beee43Available 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
54738-025-01Meclizine HCL100 in 1 BOTTLETABLET, CHEWABLE1003
54738-025-03Meclizine HCL1000 in 1 BOTTLETABLET, CHEWABLE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-025-01EA - Each54738-025e50d07ed-44a7-4675-b13c-cba61d32d66d12019-08-06
54738-025-03EA - Each54738-0252649f479-e975-427d-9743-9c119120abba12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-025MECLIZINE HCL (MECLIZINE HCL 25MG CHEWABLE TABLETS) TABLET, CHEWABLE [RICHMOND PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20171030_98e3fe5a-73c6-4dcc-b397-cc6013beee43.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HCLMECLIZINE HCL 25MG CHEWABLE TABLETSRichmond Pharmaceuticals, Inc.98e3fe5a-73c6-4dcc-b397-cc6013beee432017-10-30WarningsExact identifier
ndc (product): 54738-025

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSN98e3fe5a-73c6-4dcc-b397-cc6013beee433
995632meclizine hydrochloride 25 MG Chewable TabletSCD98e3fe5a-73c6-4dcc-b397-cc6013beee433
995632meclizine HCl 25 MG Chewable TabletPSN02d1af4d-d97d-4019-a5bf-3ec3912386762
995632meclizine hydrochloride 25 MG Chewable TabletSCD02d1af4d-d97d-4019-a5bf-3ec3912386762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54738-025-0154738002501100 TABLET, CHEWABLE in 1 BOTTLE (54738-025-01) 2015-05-010000-00-00NoNoCurrent
54738-025-03547380025031000 TABLET, CHEWABLE in 1 BOTTLE (54738-025-03) 2015-05-010000-00-00NoNoCurrent