FDA.reportPublic FDA data

MECLIZINE

Product NDC
16103-387
11-digit product format
161030387
Labeler code
16103
Product ID
16103-387_f25eaba1-2538-4b14-bc67-aa45e07b3014
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl 25mg
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Pharbest Pharmaceuticals, Inc.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-01
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage16103-387-0886f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage16103-387-1186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage16103-387-08bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage16103-387-11bd6a592717d7…303034d00443…

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
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
4bac2765-045c-405e-8006-8c5cfdfa89bcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
16103-387-082022-04-08Drug Facts
16103-387-112022-04-08Drug Facts
16103-387-082022-01-28Drug Facts
16103-387-112022-01-28Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-387-08MECLIZINE100 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1004
16103-387-11MECLIZINE1000 in 1 BOTTLE, PLASTICTABLET, CHEWABLE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-387-08EA - Each16103-3873442d87d-ab37-4744-91ee-2186d8cf33ef12019-04-11
16103-387-11EA - Each16103-3875ff12391-bd24-4d54-bf8e-094ee2d6b49712021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-387MECLIZINE (MECLIZINE HCL 25MG) TABLET, CHEWABLE [PHARBEST PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20250101_4bac2765-045c-405e-8006-8c5cfdfa89bc.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 3 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.d0d8b376-8fe9-8776-e053-2a95a90ae6512026-01-27WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4f806804-48c7-414e-a177-5d3daf5b22e32026-01-20WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLUnited Natural Foods, Inc. dba UNFI108bb943-529f-4510-b770-b54eca493ae02026-01-12WarningsExact identifier
application number: M009
Less Drowsy Motion Sickness ReliefMECLIZINE HCLRite Aid Corporation2f9ebe6b-ffde-41de-9eaa-b03d87d330052026-01-09WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATERite Aid Corporation4f532984-aeee-4dde-972c-742bdf12868f2026-01-07WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLFamily Dollar Services Ince34126e3-52ef-4999-bf61-cba9b18182592026-01-05WarningsExact identifier
application number: M009
CVS Motion Sickness Fast MeltingMECLIZINE HYDROCHLORIDECVS Pharmacy, Inc.2a723bce-a581-4558-b028-22f1f9125dd52025-12-30WarningsExact identifier
application number: M009
Wal-Dram 2 Quick-DissolvingMECLIZINE HYDROCHLORIDEWalgreen Co.f3116203-1b8f-438a-b779-7bdd90eaf79e2025-12-30WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5 MGPharbest Pharmaceuticals, Inc.8b3c9283-b618-4d57-9f15-7cf73e8737f52025-12-24WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 25MGPharbest Pharmaceuticals, Inc.4bac2765-045c-405e-8006-8c5cfdfa89bc2025-12-24WarningsExact identifier
application number: M009
ndc (product): 16103-387
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.fdcbcc4e-9370-4975-8905-1f12c73fdc8c2025-12-23WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.3a960d43-62aa-464e-92b9-d83042ba02bf2025-12-23WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.6efd3473-ee14-4ee0-8a58-d15a64a9224a2025-12-18WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLRite Aid Corporatione599dc64-ac10-4f4e-9318-e9fab05264882025-11-15WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLKroger Company64e0496c-5e09-46e9-94b9-624163d71b602025-11-05WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLWalgreen Company27bd9c74-c85e-4eeb-9e43-4120f90011872025-11-05WarningsExact identifier
application number: M009
Dramamine Original FormulaDIMENHYDRINATEMedtech Products Inc.f9302a5a-295a-4501-9332-e3f5eb3873622025-10-23WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDECVS Pharmacy, Incb57fc6c2-fbfc-24c3-e053-2995a90a33892025-10-16WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLAmerisource Bergen503f62e7-8ec8-4409-9697-4efef4ff7b152025-10-08WarningsExact identifier
application number: M009
Meclizine HCL 25 mgMECLIZINE HCLProficient Rx LPd08fa6f5-4293-4468-814e-7dccbd2812092025-10-01WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSNcf79ac74-017e-4fb4-85d3-4ea944080e8914
995632meclizine hydrochloride 25 MG Chewable TabletSCDcf79ac74-017e-4fb4-85d3-4ea944080e8914
995632meclizine HCl 25 MG Chewable TabletPSN3a6b8c81-cfb8-4194-a9ad-ed0db19b72a94
995632meclizine HCl 25 MG Chewable TabletPSN4bac2765-045c-405e-8006-8c5cfdfa89bc4
995632meclizine hydrochloride 25 MG Chewable TabletSCD3a6b8c81-cfb8-4194-a9ad-ed0db19b72a94
995632meclizine hydrochloride 25 MG Chewable TabletSCD4bac2765-045c-405e-8006-8c5cfdfa89bc4
995632meclizine HCl 25 MG Chewable TabletPSN7575b02e-2659-4fc1-9fba-f2db53c09cd13
995632meclizine hydrochloride 25 MG Chewable TabletSCD7575b02e-2659-4fc1-9fba-f2db53c09cd13
995632meclizine HCl 25 MG Chewable TabletPSN1b2f80d7-cee3-1283-e063-6394a90abc4b2
995632meclizine hydrochloride 25 MG Chewable TabletSCD1b2f80d7-cee3-1283-e063-6394a90abc4b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16103-387-0816103038708100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16103-387-08) 2018-02-010000-00-00NoNoCurrent
16103-387-11161030387111000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16103-387-11) 2018-02-010000-00-00NoNoCurrent