FDA.reportPublic FDA data

Driminate

Product NDC
0904-2051
11-digit product format
009042051
Labeler code
0904
Product ID
0904-2051_a0972926-caa6-4d35-8a38-1483cd74a925
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

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-08-27 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.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JB937PER5CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198603Internal RxNorm lookup
211482Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d2967f78-41ee-4c30-8b47-0757df9f3d91Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dramamine for KidsDIMENHYDRINATEMedtech Products Inc.12bc3f17-ed62-4d0d-9b1e-3835579e711b2025-09-10WarningsExact identifier
application number: M009
Medique Medi-MeclizineMECLIZINE HCLUnifirst First Aid Corporationb3fec2df-c41d-0b56-e053-2995a90a35e82025-09-09WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HYDROCHLORIDETARGET CORPORATION36ba2950-4a09-e5de-e063-6394a90a17712025-09-04WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5 MGAdvanced Rx LLC032a89f2-17e7-45d2-94a1-cc7a601ebdee2025-09-01WarningsExact identifier
application number: M009
DimenhydrinateDIMENHYDRINATEMajor Pharmaceuticals78d22836-a442-7c0c-e053-2991aa0a62f32025-08-13WarningsExact identifier
application number: M009
MQ Motion PatchMOTION PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.3a70bc22-8e31-2d4c-e063-6394a90a3b242025-07-21WarningsExact identifier
application number: M009
Bangbrek Bee Venom Wart Corn Callus RemoverSALICYLIC ACID 17%Brilliance Trade LLC377946a0-0e8c-70f4-e063-6294a90a1d852025-06-20WarningsExact identifier
application number: M009
Dramamine for KidsDIMENHYDRINATEMedtech Products Inc.48e2e9ef-4c88-42ef-b825-d1b0074752752025-05-06WarningsExact identifier
application number: M009
BONINE MAXMECLIZINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation7326a47e-284e-4b6f-8eb0-7933dc1e3f0d2025-04-11WarningsExact identifier
application number: M009
Meclizine HCL 25 mgMECLIZINE HCLBryant Ranch Prepackd1c58a74-5455-4a07-bcb6-cc114032ed122025-03-31WarningsExact identifier
application number: M009
BONINEMECLIZINE HYDROCHLORIDEWellSpring Pharmaceutical Corporationad3d66ca-a52c-43ba-b9e2-6269b8a413a92025-03-21WarningsExact identifier
application number: M009
BONINEMECLIZINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation0b2ea6b8-b342-4940-8922-898758fbeb312025-03-21WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEWalgreen Companyecf8d05e-0e77-f3e8-e053-2a95a90a66042025-03-11WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 25MGPD-Rx Pharmaceuticals, Inc.cf79ac74-017e-4fb4-85d3-4ea944080e892025-03-06WarningsExact identifier
application number: M009
HIONFURT Motion SicknessMOTION SICKNESS NATURAL HERBAL PLANTPuning Huiyu E-Commerce Co., Ltd.2e2c9073-1dcf-a3e8-e063-6394a90a6ee32025-02-15WarningsExact identifier
application number: M009
HIONFURT Motion SicknessMOTION SICKNESS NATURAL HERBAL PLANT LEMONPuning Huiyu E-Commerce Co., Ltd.2e2b3729-f8b0-605f-e063-6294a90a90c82025-02-15WarningsExact identifier
application number: M009
HIONFURT Motion SicknessMOTION SICKNESS NATURAL HERBAL PLANT LAVENDERPuning Huiyu E-Commerce Co., Ltd.2e30b09d-838d-59fb-e063-6394a90aa9842025-02-15WarningsExact identifier
application number: M009
HIONFURT Motion SicknessMOTION SICKNESS PREVENT NAUSEA,DIZZINESS VOMITINGPuning Huiyu E-Commerce Co., Ltd.2e31419e-3ccd-d7b5-e063-6394a90ac7652025-02-15WarningsExact identifier
application number: M009
Dramamine for KidsDIMENHYDRINATEMedtech Products Inc.3ccd6eb4-ba7e-4a6a-abb9-a6ef3196240c2025-02-12WarningsExact identifier
application number: M009
Motion SicknessMOTION SICKNESS NATURAL HERBAL PLANTPuning Huiyu E-Commerce Co., Ltd.2db09ade-c94b-5f5f-e063-6394a90af9dc2025-02-09WarningsExact identifier
application number: M009

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 pack1992-12-01NoNoCurrent
0904-2051-59009042051591 BOTTLE, PLASTIC in 1 CARTON (0904-2051-59) / 100 TABLET in 1 BOTTLE, PLASTIC1992-12-010000-00-00NoNoCurrent