FDA.reportPublic FDA data

Dimenhydrinate

Product NDC
70000-0404
11-digit product format
700000404
Labeler code
70000
Product ID
70000-0404_4b4343e5-4d4d-6a4a-e063-6394a90ad2bc
Type
HUMAN OTC DRUG
Nonproprietary name
Dimenhydrinate
Dosage form
TABLET
Route
ORAL
Labeler
LEADER/ Cardinal Health 110, Inc.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-04
Marketing end
2029-02-28
Substance
DIMENHYDRINATE
Active strength
50 mg/1
NDC exclude flag
No
Current FDA listing
Yes

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
Dimenhydrinate

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7c4adbdb-9bce-0c9c-e053-2a91aa0a8107Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0404-1Dimenhydrinate12 in 1 BLISTER PACKTABLET127
70000-0404-1Dimenhydrinate1 in 1 CARTONTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0404-1EA - Each70000-04046f2800c2-343e-46a1-8e47-6d7ca70df82d12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0404DIMENHYDRINATE TABLET [LEADER/ CARDINAL HEALTH 110, INC.]6Current NDC, Legacy NDC, 2 package rows20250212_7c4adbdb-9bce-0c9c-e053-2a91aa0a8107.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 TabletPSN7c4adbdb-9bce-0c9c-e053-2a91aa0a81077
198603dimenhydrinate 50 MG Oral TabletSCD7c4adbdb-9bce-0c9c-e053-2a91aa0a81077

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0404-1700000404011 BLISTER PACK in 1 CARTON (70000-0404-1) / 12 TABLET in 1 BLISTER PACK1 blister pack2019-01-042029-02-28NoNoCurrent