FDA.reportPublic FDA data

MECLIZINE

Product NDC
71335-1215
Requested package NDC
71335-1215-9
11-digit product format
713351215
Labeler code
71335
Product ID
71335-1215_dc78e0fc-fccc-45a2-a33b-2a2eeb5caab9
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl 25mg
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
part336
Marketing category
OTC MONOGRAPH FINAL
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

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
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
623db9de-4224-47ce-84b7-6eaefe97290eAvailable 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
71335-1215-0MECLIZINE120 in 1 BOTTLETABLET, CHEWABLE1201
71335-1215-1MECLIZINE30 in 1 BOTTLETABLET, CHEWABLE301
71335-1215-2MECLIZINE20 in 1 BOTTLETABLET, CHEWABLE201
71335-1215-3MECLIZINE25 in 1 BOTTLETABLET, CHEWABLE251
71335-1215-4MECLIZINE40 in 1 BOTTLETABLET, CHEWABLE401
71335-1215-5MECLIZINE60 in 1 BOTTLETABLET, CHEWABLE601
71335-1215-6MECLIZINE90 in 1 BOTTLETABLET, CHEWABLE901
71335-1215-7MECLIZINE8 in 1 BOTTLETABLET, CHEWABLE81
71335-1215-8MECLIZINE14 in 1 BOTTLETABLET, CHEWABLE141
71335-1215-9MECLIZINE10 in 1 BOTTLETABLET, CHEWABLE101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1215-1EA - Each71335-1215e766e90b-04e4-4a08-9f77-c0c195f01e2512019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1215MECLIZINE (MECLIZINE HCL 25MG) TABLET, CHEWABLE [BRYANT RANCH PREPACK]1Current NDC, Legacy NDC, 10 package rows20190614_623db9de-4224-47ce-84b7-6eaefe97290e.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
MECLIZINEMECLIZINE HCL 25MGBryant Ranch Prepack623db9de-4224-47ce-84b7-6eaefe97290e2019-06-13WarningsExact identifier
ndc (package): 71335-1215-9
ndc (product): 71335-1215
ndc11 (package): 71335121509

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSN623db9de-4224-47ce-84b7-6eaefe97290e1
995632meclizine hydrochloride 25 MG Chewable TabletSCD623db9de-4224-47ce-84b7-6eaefe97290e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1215-97133512150910 TABLET, CHEWABLE in 1 BOTTLE (71335-1215-9) 2019-05-200000-00-00NoNoCurrent