Meclizine HCl

Product NDC
0536-3990
11-digit product format
005363990
Labeler code
0536
Product ID
0536-3990_c500c05e-d501-4e0a-b01d-c0223ae05191
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Rugby Laboratories Inc.
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2008-07-22
Marketing end
0000-00-00
Substance
MECLIZINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0536-3990DDiscontinued by firm2026-08-10
excluded packagepackage0536-39900536-3990-01DDiscontinued by firm2026-08-10
excluded packagepackage0536-39900536-3990-10DDiscontinued by firm2026-08-10

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-3990-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-3990-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-3990-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-3990-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-3990-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-3990-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-3990-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-3990-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-3990-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-3990-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-3990-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-3990-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-3990-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-3990-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-3990-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-3990-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-3990-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-3990-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-3990-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-3990-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-3990-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-3990-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-3990-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-3990-01557ba5c1ecfa…9c80585c8c6e…

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-3990-01EA - Each0536-399019e21193-3400-4ae7-bfeb-be4e3be3b03e12013-02-13
0536-3990-10EA - Each0536-3990037f1ac0-8bb3-4253-9b4f-210bfa1a8b6312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HCL TABLET [BRYANT RANCH PREPACK]1000
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HCL TABLET [BRYANT RANCH PREPACK]1000
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MECLIZINE HCL TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HCL TABLET [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MECLIZINE HCL TABLET [BRYANT RANCH PREPACK]1000
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2MECLIZINE HCL TABLET [BRYANT RANCH PREPACK]1000
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMECLIZINE HCL TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HCL TABLET [BRYANT RANCH PREPACK]1000
RASPBERRYINACTIVE INGREDIENT4N14V5R27WMECLIZINE HCL TABLET [BRYANT RANCH PREPACK]1000
SUCROSEINACTIVE INGREDIENTC151H8M554MECLIZINE HCL TABLET [BRYANT RANCH PREPACK]1000
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]3
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2MECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]3
RASPBERRYINACTIVE INGREDIENT4N14V5R27WMECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]3
SUCROSEINACTIVE INGREDIENTC151H8M554MECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]3
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HCL TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MECLIZINE HYDROCHLORIDEACTIVE INGREDIENTHDP7W44CIOMECLIZINE HCL TABLET [RUGBY LABORATORIES INC.]2
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HCL TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MECLIZINEACTIVE MOIETY3L5TQ84570MECLIZINE HCL TABLET [RUGBY LABORATORIES INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MECLIZINE HCL TABLET [PREFERRED PHARMACEUTICALS, INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MECLIZINE HCL TABLET [RUGBY LABORATORIES INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HCL TABLET [RUGBY LABORATORIES INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMECLIZINE HCL TABLET [PREFERRED PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MECLIZINE HCL TABLET [RUGBY LABORATORIES INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MECLIZINE HCL TABLET [PREFERRED PHARMACEUTICALS, INC.]2
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2MECLIZINE HCL TABLET [RUGBY LABORATORIES INC.]2
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2MECLIZINE HCL TABLET [PREFERRED PHARMACEUTICALS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMECLIZINE HCL TABLET [RUGBY LABORATORIES INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMECLIZINE HCL TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HCL TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MECLIZINE HCL TABLET [RUGBY LABORATORIES INC.]2
RASPBERRYINACTIVE INGREDIENT4N14V5R27WMECLIZINE HCL TABLET [RUGBY LABORATORIES INC.]2
RASPBERRYINACTIVE INGREDIENT4N14V5R27WMECLIZINE HCL TABLET [PREFERRED PHARMACEUTICALS, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554MECLIZINE HCL TABLET [RUGBY LABORATORIES INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554MECLIZINE HCL TABLET [PREFERRED PHARMACEUTICALS, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995632meclizine HCl 25 MG Chewable TabletPSNcf1332f0-8662-45ed-a76f-3e620f60f05b3
995632meclizine hydrochloride 25 MG Chewable TabletSCDcf1332f0-8662-45ed-a76f-3e620f60f05b3