FDA.reportPublic FDA data

Meclizine Hydrochloride

Product NDC
24689-138
11-digit product format
246890138
Labeler code
24689
Product ID
24689-138_2b4a16c2-d9c9-61ab-e063-6394a90a863a
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
APNAR PHARMA LP
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-29
Substance
MECLIZINE HYDROCHLORIDE
Active strength
12.5 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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 Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE12.5 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995624Internal RxNorm lookup
995666Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e4d785a7-a688-3acb-e053-2a95a90a6d2eAvailable 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
24689-138-01Meclizine Hydrochloride100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24689-138-01EA - Each24689-138574573b9-a5c0-4464-83ef-c2c265984a0812022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24689-138MECLIZINE HYDROCHLORIDE TABLET [APNAR PHARMA LP]2Current NDC, Legacy NDC, 1 package rows20250112_e4d785a7-a688-3acb-e053-2a95a90a6d2e.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 6 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Airmit AceDIMENHYDRINATESato Pharmaceutical Co., Ltd.a98d252d-4cfa-496a-ab2c-627f45f0d7d92023-12-01WarningsExact identifier
application number: M009
Meclizine HClMECLIZINE HYDROCHLORIDEBluePoint Laboratoriesd9cae5a6-8d4b-bdaf-e053-2995a90a7d442023-11-17WarningsExact identifier
application number: M009
ZenTrip Motion SicknessMECLIZINE HYDROCHLORIDESato Pharmaceutical Co., LTDbd86c4c7-b6f0-e3e8-e053-2995a90a44542023-11-03WarningsExact identifier
application number: M009
Travel-EaseMECLIZINE HCLGeri-Care Pharmaceutical Corpe3c64eb9-4972-29d9-e053-2a95a90a2a8a2023-10-25WarningsExact identifier
application number: M009
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d95240bb-02f2-3226-e053-2995a90afacd2022-03-03WarningsExact identifier
application number: M009
Allergy DyeFreeALLERGY DYEFREEAllegiant Health15736bb8-5a5b-489d-83ad-4cf34ec629562021-04-26WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATE 50MGAllegiant Health7b0aa993-f08f-4dff-a82d-f35b3ebe3cc12019-12-12WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSNe4d785a7-a688-3acb-e053-2a95a90a6d2e2
995666meclizine HCl 25 MG Oral TabletPSNe4d785a7-a688-3acb-e053-2a95a90a6d2e2
995624meclizine hydrochloride 12.5 MG Oral TabletSCDe4d785a7-a688-3acb-e053-2a95a90a6d2e2
995666meclizine hydrochloride 25 MG Oral TabletSCDe4d785a7-a688-3acb-e053-2a95a90a6d2e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24689-138-0124689013801100 TABLET in 1 BOTTLE (24689-138-01) 100 tablet2022-07-290000-00-00NoNoCurrent