FDA.reportPublic FDA data

Wal-Dram

Product NDC
0363-0198
Requested package NDC
0363-0198-08
11-digit product format
003630198
Labeler code
0363
Product ID
0363-0198_0fc5ad4d-3bb4-4122-a7f8-9ec23683cba7
Type
HUMAN OTC DRUG
Nonproprietary name
Dimenhydrinate
Dosage form
TABLET
Route
ORAL
Labeler
Walgreen Company
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1992-12-01
Marketing end
2023-10-22
Substance
DIMENHYDRINATE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 packagepackage0363-01980363-0198-08DDiscontinued 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 · 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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-01980363-0198-08DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-01980363-0198-08DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0198-08EA - Each0363-019824356a10-dfea-403c-a641-6e79f9713dcd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMENHYDRINATEACTIVE INGREDIENTJB937PER5CWAL-DRAM (DIMENHYDRINATE) TABLET [WALGREEN CO.]18
CHLORTHEOPHYLLINEACTIVE MOIETYGE2UA340FMWAL-DRAM (DIMENHYDRINATE) TABLET [WALGREEN CO.]18
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JWAL-DRAM (DIMENHYDRINATE) TABLET [WALGREEN CO.]18
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UWAL-DRAM (DIMENHYDRINATE) TABLET [WALGREEN CO.]18
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48WAL-DRAM (DIMENHYDRINATE) TABLET [WALGREEN CO.]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30WAL-DRAM (DIMENHYDRINATE) TABLET [WALGREEN CO.]18
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APWAL-DRAM (DIMENHYDRINATE) TABLET [WALGREEN CO.]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0198WAL-DRAM (DIMENHYDRINATE) TABLET [WALGREEN COMPANY]28Legacy NDC20240704_a0af458b-86fe-424c-9067-d14b09491c5a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0198-08003630198084 BLISTER PACK in 1 CARTON (0363-0198-08) > 6 TABLET in 1 BLISTER PACK4 blister pack1992-12-012023-10-22NoNoCurrent