FDA.reportPublic FDA data

Meclizine HCL 25 mg

Product NDC
70934-197
Requested package NDC
70934-197-30
11-digit product format
709340197
Labeler code
70934
Product ID
70934-197_b9306c09-205a-59fe-e053-2995a90a91c3
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-12-05
Marketing end
0000-00-00
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70934-19770934-197-30DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-197-302021-01-31C16284748780-1ba0f9c33-4362-a910-e053-dadaa90a0b85Meclizine HCL 25 mg
70934-197-302021-01-29C16284748780-1ba0f9c33-4362-a910-e053-dadaa90a0b85Meclizine HCL 25 mg

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-197-307093401973030 TABLET in 1 BOTTLE, PLASTIC (70934-197-30) 30 tablet2018-12-050000-00-00NoNoCurrent