FDA.reportPublic FDA data

Motion Sickness

Product NDC
36800-630
11-digit product format
368000630
Labeler code
36800
Product ID
36800-630_7c15e321-19d4-4e2d-ab08-2be620298c87
Type
HUMAN OTC DRUG
Nonproprietary name
Dimenhydrinate
Dosage form
TABLET
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-05-31
Marketing end
2020-05-31
Substance
DIMENHYDRINATE
Active strength
50 mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct36800-630DDiscontinued by firm2026-08-03
excluded packagepackage36800-63036800-630-12DDiscontinued by firm2026-08-03

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 · 24 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 packagepackage36800-630-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36800-630-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36800-630-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36800-630-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36800-630-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36800-630-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36800-630-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36800-630-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage36800-630-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage36800-630-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage36800-630-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage36800-630-12557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMENHYDRINATEACTIVE INGREDIENTJB937PER5CMOTION SICKNESS (DIMENHYDRINATE) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MMOTION SICKNESS (DIMENHYDRINATE) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JMOTION SICKNESS (DIMENHYDRINATE) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMOTION SICKNESS (DIMENHYDRINATE) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MOTION SICKNESS (DIMENHYDRINATE) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MOTION SICKNESS (DIMENHYDRINATE) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]2