FDA.reportPublic FDA data

Meclizine HCL 25 mg

Product NDC
71335-1607
Requested package NDC
71335-1607-8
11-digit product format
713351607
Labeler code
71335
Product ID
71335-1607_afe16058-294e-4e4f-9a1b-4af4e96eedea
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-01
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-160771335-1607-8IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-160771335-1607-8IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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 25 mg
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
d1c58a74-5455-4a07-bcb6-cc114032ed12Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71335-1607-02024-05-21Meclizine HCL 25 mg
71335-1607-12024-05-21Meclizine HCL 25 mg
71335-1607-22024-05-21Meclizine HCL 25 mg
71335-1607-32024-05-21Meclizine HCL 25 mg
71335-1607-42024-05-21Meclizine HCL 25 mg
71335-1607-52024-05-21Meclizine HCL 25 mg
71335-1607-62024-05-21Meclizine HCL 25 mg
71335-1607-72024-05-21Meclizine HCL 25 mg
71335-1607-82024-05-21Meclizine HCL 25 mg
71335-1607-92024-05-21Meclizine HCL 25 mg
71335-1607-02024-01-30Meclizine HCL 25 mg
71335-1607-12024-01-30Meclizine HCL 25 mg
71335-1607-22024-01-30Meclizine HCL 25 mg
71335-1607-32024-01-30Meclizine HCL 25 mg
71335-1607-42024-01-30Meclizine HCL 25 mg
71335-1607-52024-01-30Meclizine HCL 25 mg
71335-1607-62024-01-30Meclizine HCL 25 mg
71335-1607-72024-01-30Meclizine HCL 25 mg
71335-1607-82024-01-30Meclizine HCL 25 mg
71335-1607-92024-01-30Meclizine HCL 25 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1607-0Meclizine HCL 25 mg120 in 1 BOTTLETABLET1205
71335-1607-1Meclizine HCL 25 mg30 in 1 BOTTLETABLET305
71335-1607-2Meclizine HCL 25 mg20 in 1 BOTTLETABLET205
71335-1607-3Meclizine HCL 25 mg25 in 1 BOTTLETABLET255
71335-1607-4Meclizine HCL 25 mg40 in 1 BOTTLETABLET405
71335-1607-5Meclizine HCL 25 mg60 in 1 BOTTLETABLET605
71335-1607-6Meclizine HCL 25 mg90 in 1 BOTTLETABLET905
71335-1607-7Meclizine HCL 25 mg8 in 1 BOTTLETABLET85
71335-1607-8Meclizine HCL 25 mg14 in 1 BOTTLETABLET145
71335-1607-9Meclizine HCL 25 mg10 in 1 BOTTLETABLET105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1607MECLIZINE HCL 25 MG (MECLIZINE HCL) TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20250402_d1c58a74-5455-4a07-bcb6-cc114032ed12.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 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dramamine OrangeDIMENHYDRINATEMedtech Products Inc.76166156-bce1-492f-833e-6bbd07859c3f2026-09-17WarningsExact identifier
application number: M009
Pepto Nausea Motion SicknessMECLIZINE HCLTHE PROCTER & GAMBLE MANUFACTURING COMPANY29a1bd1e-d0e0-478f-e063-6394a90ab0aa2026-09-10WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEA-S Medication Solutions2518b0b6-35ab-49f4-936c-1eafea04b4662026-09-09WarningsExact identifier
application number: M009
Dramamine Less DrowsyMECLIZINE HYDROCHLORIDEMedtech Products Inc.fa6a0969-7427-4b87-bc04-a2792665c2182026-09-04WarningsExact identifier
application number: M009
Less Drowsy Motion Sickness ReliefMECLIZINE HCLWal-Mart Stores Inc277a6266-e641-4621-bbb9-64195d51b66a2026-08-28WarningsExact identifier
application number: M009
Nausea ReliefMECLIZINE HCLWALMART INC.8010741e-61b2-4c1f-9f0e-21612878fa0e2026-08-28WarningsExact identifier
application number: M009
Motion SicknessMECLIZINE HCLH E B9837e9af-c542-4c0f-be33-94927d67c6a72026-08-21WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEBryant Ranch Prepackcd82fca9-a8dc-4545-8e64-b67d644832e72026-08-20WarningsExact identifier
application number: M009
Motion SicknessDIMENHYDRINATEStrategic Sourcing Services LLCbe8f91d4-6e4f-4d47-93e9-7fb91160b7df2026-08-17WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEWalgreen Companyace7eba4-e033-48f5-8533-c3ea9dfc32b02026-08-12WarningsExact identifier
application number: M009
Motion SicknessMECLIZINE HCLStrategic Sourcing Services LLC76fb6471-09b0-4c51-bacc-b3533b6aa9712026-08-07WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATECardinal Health 110, LLC. DBA Leaderce83a868-bdd8-4c77-9bc0-664133028f752026-08-06WarningsExact identifier
application number: M009
Less Drowsy Formula Motion Sickness ReliefMECLIZINE HCLSalado Sales, Inc.273235b0-dacc-4a95-91be-91e13a2c6d102026-08-05WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLL.N.K. International, Inc.8e1889de-fbef-44f1-bbfb-c68a78e6330c2026-07-30WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEChain Drug Marketing Association, Inc.00a327c6-6b86-4702-8c04-55c405c1404c2026-07-23WarningsExact identifier
application number: M009
Pepto Motion SicknessMECLIZINE HCLTHE PROCTER & GAMBLE MANUFACTURING COMPANY571e3eeb-ae9e-7054-e063-6394a90a26342026-07-21WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDERugby Laboratoriesb57f14a7-3852-03db-e053-2a95a90a80d62026-07-16WarningsExact identifier
application number: M009
Motion SicknessDIMENHYDRINATECVS Pharmacy0998947c-cfba-497e-bf7a-9c7f8fff17642026-07-16WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLTopco Associates, LLC307e3144-3b01-4bd0-9155-6b58fc4cab922026-07-09WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEL.N.K. International, Inc.95aae32f-6b3f-469d-86a5-c201a53f862a2026-06-29WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSNd1c58a74-5455-4a07-bcb6-cc114032ed125
995632meclizine hydrochloride 25 MG Chewable TabletSCDd1c58a74-5455-4a07-bcb6-cc114032ed125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1607-87133516070814 TABLET in 1 BOTTLE (71335-1607-8) 14 tablet2022-02-140000-00-00NoNoCurrent