FDA.reportPublic FDA data

Meclizine HCL 12.5 mg

Product NDC
69618-027
11-digit product format
696180027
Labeler code
69618
Product ID
69618-027_2bc82d20-1473-46c7-e063-6394a90a0d44
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCL 12.5 mg
Dosage form
TABLET
Route
ORAL
Labeler
Reliable 1 Laboratories LLC
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-01
Substance
MECLIZINE HYDROCHLORIDE
Active strength
12.5 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 12.5 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995624

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-027-012023-03-29C16284748780-1f386c649-eb62-0266-e053-dadaa90a7c1aMeclizine HCL 12.5
69618-027-102023-03-29C16284748780-1f386c649-eb62-0266-e053-dadaa90a7c1aMeclizine HCL 12.5
69618-027-012023-01-30C16284748780-1f386c649-eb62-0266-e053-dadaa90a7c1aMeclizine HCL 12.5
69618-027-102023-01-30C16284748780-1f386c649-eb62-0266-e053-dadaa90a7c1aMeclizine HCL 12.5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-027-01Meclizine HCL 12.5 mg100 in 1 BOTTLE, PLASTICTABLET1006
69618-027-10Meclizine HCL 12.5 mg1000 in 1 BOTTLE, PLASTICTABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-027-01EA - Each69618-027e78a02a0-6dfa-432d-8cbc-ddf3e88d963712016-05-16
69618-027-10EA - Each69618-0277ce7769a-4a4f-4fab-a44b-6e35d580602312016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-027MECLIZINE HCL 12.5 MG TABLET [RELIABLE 1 LABORATORIES LLC]6Current NDC, Legacy NDC, 2 package rows20250117_32832b0f-0b38-27ce-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN32832b0f-0b38-27ce-e054-00144ff8d46c6
995624meclizine hydrochloride 12.5 MG Oral TabletSCD32832b0f-0b38-27ce-e054-00144ff8d46c6
995624meclizine HCl 12.5 MG Oral TabletPSN3ffa63f2-ea06-4be0-9f59-162c2a9604fc4
995624meclizine hydrochloride 12.5 MG Oral TabletSCD3ffa63f2-ea06-4be0-9f59-162c2a9604fc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69618-027-0169618002701100 TABLET in 1 BOTTLE, PLASTIC (69618-027-01) 100 tablet2015-11-010000-00-00NoNoCurrent
69618-027-10696180027101000 TABLET in 1 BOTTLE, PLASTIC (69618-027-10) 1000 tablet2015-11-010000-00-00NoNoCurrent