FDA.reportPublic FDA data

Meclizine HCl

Product NDC
68788-8529
Requested package NDC
68788-8529-3
11-digit product format
687888529
Labeler code
68788
Product ID
68788-8529_a2db9af5-9e32-4296-9688-b92e560e67cf
Type
HUMAN OTC DRUG
Nonproprietary name
MECLIZINE HYDROCHLORIDE CHEWABLE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
336
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-06
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 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 HCl
Listing expiration
2027-12-31

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
a7f3f32a-0651-4e55-ac51-c85a23352a24Available 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
68788-8529-1Meclizine HCl10 in 1 BOTTLETABLET, CHEWABLE103
68788-8529-3Meclizine HCl30 in 1 BOTTLETABLET, CHEWABLE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8529-1EA - Each68788-8529674def47-e92a-4646-92fe-c15cc388774612023-12-05
68788-8529-3EA - Each68788-8529b3740cbc-0707-45be-b3a4-aebeb454186712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8529MECLIZINE HCL (MECLIZINE HYDROCHLORIDE CHEWABLE) TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 2 package rows20240704_a7f3f32a-0651-4e55-ac51-c85a23352a24.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 CHEWABLEPreferred Pharmaceuticals Inc.a7f3f32a-0651-4e55-ac51-c85a23352a242026-06-12WarningsExact identifier
ndc (package): 68788-8529-3
ndc (product): 68788-8529
ndc11 (package): 68788852903

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSNa7f3f32a-0651-4e55-ac51-c85a23352a243
995632meclizine hydrochloride 25 MG Chewable TabletSCDa7f3f32a-0651-4e55-ac51-c85a23352a243

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8529-36878885290330 TABLET, CHEWABLE in 1 BOTTLE (68788-8529-3) 2023-10-06NoNoCurrent