FDA.reportPublic FDA data

Meclizine HCL

Product NDC
17714-115
11-digit product format
177140115
Labeler code
17714
Product ID
17714-115_5cc96295-eaf6-1c2a-e053-2a91aa0a18b3
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl 25mg Chewable Tablets
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Advance Pharmaceutical Inc.
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-07-01
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
ef43c413-90a0-4d33-90a7-a29db3cdfa92Available 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
17714-115-01Meclizine HCL100 in 1 BOTTLETABLET, CHEWABLE1002
17714-115-10Meclizine HCL1000 in 1 BOTTLETABLET, CHEWABLE10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17714-115MECLIZINE HCL (MECLIZINE HCL 25MG CHEWABLE TABLETS) TABLET, CHEWABLE [ADVANCE PHARMACEUTICAL INC.]2Current NDC, Legacy NDC, 2 package rows20171031_ef43c413-90a0-4d33-90a7-a29db3cdfa92.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 TABLETSAdvance Pharmaceutical Inc.ef43c413-90a0-4d33-90a7-a29db3cdfa922017-10-30WarningsExact identifier
ndc (product): 17714-115

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSNef43c413-90a0-4d33-90a7-a29db3cdfa922
995632meclizine hydrochloride 25 MG Chewable TabletSCDef43c413-90a0-4d33-90a7-a29db3cdfa922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17714-115-0117714011501100 TABLET, CHEWABLE in 1 BOTTLE (17714-115-01) 2013-07-010000-00-00NoNoCurrent
17714-115-10177140115101000 TABLET, CHEWABLE in 1 BOTTLE (17714-115-10) 2013-07-010000-00-00NoNoCurrent