FDA.reportPublic FDA data

Driminate

Product NDC
0904-2051
11-digit product format
009042051
Labeler code
0904
Product ID
0904-2051_4735c97b-20db-4dfe-81b2-dcb08859a544
Type
HUMAN OTC DRUG
Nonproprietary name
Dimenhydrinate
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1992-12-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Driminate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMENHYDRINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJB937PER5C

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-2051-12Driminate6 in 1 BLISTER PACKTABLET626
0904-2051-12Driminate2 in 1 CARTONTABLET226
0904-2051-59Driminate100 in 1 BOTTLE, PLASTICTABLET10026
0904-2051-59Driminate1 in 1 CARTONTABLET126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-2051-12EA - Each0904-20514989e796-050f-448b-b3e0-1c0a4596af0512012-07-24
0904-2051-59EA - Each0904-2051d4a56ff5-028d-4d12-a116-d74cf39917c512013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMENHYDRINATEACTIVE INGREDIENTJB937PER5CDRIMINATE (DIMENHYDRINATE) TABLET [MAJOR PHARMACEUTICALS]8
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDRIMINATE (DIMENHYDRINATE) TABLET [MAJOR PHARMACEUTICALS]8
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JDRIMINATE (DIMENHYDRINATE) TABLET [MAJOR PHARMACEUTICALS]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDRIMINATE (DIMENHYDRINATE) TABLET [MAJOR PHARMACEUTICALS]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DRIMINATE (DIMENHYDRINATE) TABLET [MAJOR PHARMACEUTICALS]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DRIMINATE (DIMENHYDRINATE) TABLET [MAJOR PHARMACEUTICALS]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDRIMINATE (DIMENHYDRINATE) TABLET [MAJOR PHARMACEUTICALS]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-2051DRIMINATE (DIMENHYDRINATE) TABLET [MAJOR PHARMACEUTICALS]22Current NDC, Legacy NDC, 4 package rows20250206_d2967f78-41ee-4c30-8b47-0757df9f3d91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198603dimenhyDRINATE 50 MG Oral TabletPSNd2967f78-41ee-4c30-8b47-0757df9f3d9126
211482Driminate 50 MG Oral TabletPSNd2967f78-41ee-4c30-8b47-0757df9f3d9126
211482dimenhydrinate 50 MG Oral Tablet [Driminate]SBDd2967f78-41ee-4c30-8b47-0757df9f3d9126
198603dimenhydrinate 50 MG Oral TabletSCDd2967f78-41ee-4c30-8b47-0757df9f3d9126
211482Driminate 50 MG Oral TabletSYd2967f78-41ee-4c30-8b47-0757df9f3d9126
198603dimenhyDRINATE 50 MG Oral TabletPSNe2737ab2-b6d6-4da1-a8e1-3d2b261ec1b51
211482Driminate 50 MG Oral TabletPSNe2737ab2-b6d6-4da1-a8e1-3d2b261ec1b51
211482dimenhydrinate 50 MG Oral Tablet [Driminate]SBDe2737ab2-b6d6-4da1-a8e1-3d2b261ec1b51
198603dimenhydrinate 50 MG Oral TabletSCDe2737ab2-b6d6-4da1-a8e1-3d2b261ec1b51
211482Driminate 50 MG Oral TabletSYe2737ab2-b6d6-4da1-a8e1-3d2b261ec1b51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-2051-12009042051122 BLISTER PACK in 1 CARTON (0904-2051-12) / 6 TABLET in 1 BLISTER PACK2 blister pack1992-12-01NoNoHistorical
0904-2051-59009042051591 BOTTLE, PLASTIC in 1 CARTON (0904-2051-59) / 100 TABLET in 1 BOTTLE, PLASTIC1992-12-010000-00-00NoNoCurrent