FDA.reportPublic FDA data

Medique Medi-Meclizine

Product NDC
47682-480
Requested package NDC
47682-480-15
11-digit product format
476820480
Labeler code
47682
Product ID
47682-480_da59e205-5e59-9957-e053-2a95a90a44be
Type
HUMAN OTC DRUG
Nonproprietary name
MECLIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Unifirst First Aid Corporation
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-09-01
Marketing end
2022-08-01
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage47682-48047682-480-15DDiscontinued by firm2026-10-16

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.

DailyMed Product Concepts#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMEDIQUE MEDI-MECLIZINE (MECLIZINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]1
MECLIZINEACTIVE MOIETY3L5TQ84570MEDIQUE MEDI-MECLIZINE (MECLIZINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMEDIQUE MEDI-MECLIZINE (MECLIZINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEDIQUE MEDI-MECLIZINE (MECLIZINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMEDIQUE MEDI-MECLIZINE (MECLIZINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDIQUE MEDI-MECLIZINE (MECLIZINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEDIQUE MEDI-MECLIZINE (MECLIZINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MEDIQUE MEDI-MECLIZINE (MECLIZINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDIQUE MEDI-MECLIZINE (MECLIZINE HYDROCHLORIDE) TABLET [UNIFIRST FIRST AID CORPORATION]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995666meclizine HCl 25 MG Oral TabletPSNd7419e82-55d7-4699-a2d5-c45c54f845c73
995666meclizine hydrochloride 25 MG Oral TabletSCDd7419e82-55d7-4699-a2d5-c45c54f845c73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-480-1547682048015500 PACKET in 1 BOX (47682-480-15) > 2 TABLET in 1 PACKET (47682-480-99) 500 packet2018-11-082022-08-01NoNoCurrent