FDA.reportPublic FDA data

Meclizine HCl

Product NDC
71335-9751
Requested package NDC
71335-9751-0
11-digit product format
713359751
Labeler code
71335
Product ID
71335-9751_b5813836-d2ea-4aea-b894-fe428dd7e91d
Type
HUMAN OTC DRUG
Nonproprietary name
MECLIZINE HYDROCHLORIDE CHEWABLE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M009.50
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-18
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 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
12446adb-0ff6-4f92-8bb2-b64b11d47e76Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9751-0Meclizine HCl120 in 1 BOTTLETABLET, CHEWABLE120102
71335-9751-1Meclizine HCl30 in 1 BOTTLETABLET, CHEWABLE30102
71335-9751-2Meclizine HCl20 in 1 BOTTLETABLET, CHEWABLE20102
71335-9751-3Meclizine HCl25 in 1 BOTTLETABLET, CHEWABLE25102
71335-9751-4Meclizine HCl40 in 1 BOTTLETABLET, CHEWABLE40102
71335-9751-5Meclizine HCl60 in 1 BOTTLETABLET, CHEWABLE60102
71335-9751-6Meclizine HCl90 in 1 BOTTLETABLET, CHEWABLE90102
71335-9751-7Meclizine HCl8 in 1 BOTTLETABLET, CHEWABLE8102
71335-9751-8Meclizine HCl14 in 1 BOTTLETABLET, CHEWABLE14102
71335-9751-9Meclizine HCl10 in 1 BOTTLETABLET, CHEWABLE10102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9751MECLIZINE HCL (MECLIZINE HYDROCHLORIDE CHEWABLE) TABLET, CHEWABLE [BRYANT RANCH PREPACK]102Current NDC, 10 package rows20241226_12446adb-0ff6-4f92-8bb2-b64b11d47e76.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 HYDROCHLORIDE CHEWABLEBryant Ranch Prepack12446adb-0ff6-4f92-8bb2-b64b11d47e762024-12-12WarningsExact identifier
ndc (package): 71335-9751-0
ndc (product): 71335-9751
ndc11 (package): 71335975100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSN12446adb-0ff6-4f92-8bb2-b64b11d47e76102
995632meclizine hydrochloride 25 MG Chewable TabletSCD12446adb-0ff6-4f92-8bb2-b64b11d47e76102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9751-071335975100120 TABLET, CHEWABLE in 1 BOTTLE (71335-9751-0) 2024-12-12NoNoCurrent