FDA.reportPublic FDA data

Meclizine HCl

Product NDC
16571-824
11-digit product format
165710824
Labeler code
16571
Product ID
16571-824_38d4f79d-74ec-4e2b-b5d3-7c3eed2a4821
Type
HUMAN OTC DRUG
Nonproprietary name
MECLIZINE HYDROCHLORIDE CHEWABLE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
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

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
6ab6cf0e-a6c9-4b5a-95c1-37c279bf18dcAvailable 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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-824-01Meclizine HCl100 in 1 BOTTLETABLET, CHEWABLE1002
16571-824-10Meclizine HCl1000 in 1 BOTTLETABLET, CHEWABLE10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-824-01EA - Each16571-82422e61447-4473-4367-ad19-2356f9186e4112022-11-07
16571-824-10EA - Each16571-824c3998c46-db63-4938-a29e-2998bfb410ec12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-824MECLIZINE HCL (MECLIZINE HYDROCHLORIDE CHEWABLE) TABLET, CHEWABLE [RISING PHARMA HOLDINGS, INC.]2Current NDC, Legacy NDC, 2 package rows20241116_6ab6cf0e-a6c9-4b5a-95c1-37c279bf18dc.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 CHEWABLERising Pharma Holdings, Inc.6ab6cf0e-a6c9-4b5a-95c1-37c279bf18dc2024-11-08WarningsExact identifier
ndc (product): 16571-824

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
995632meclizine HCl 25 MG Chewable TabletPSNa7f3f32a-0651-4e55-ac51-c85a23352a243
995632meclizine hydrochloride 25 MG Chewable TabletSCDa7f3f32a-0651-4e55-ac51-c85a23352a243
995632meclizine HCl 25 MG Chewable TabletPSN6ab6cf0e-a6c9-4b5a-95c1-37c279bf18dc2
995632meclizine hydrochloride 25 MG Chewable TabletSCD6ab6cf0e-a6c9-4b5a-95c1-37c279bf18dc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16571-824-0116571082401100 TABLET, CHEWABLE in 1 BOTTLE (16571-824-01) 2022-08-180000-00-00NoNoCurrent
16571-824-10165710824101000 TABLET, CHEWABLE in 1 BOTTLE (16571-824-10) 2022-08-180000-00-00NoNoCurrent