FDA.reportPublic FDA data

Dimenhydrinate

Product NDC
69842-206
11-digit product format
698420206
Labeler code
69842
Product ID
69842-206_5411da37-a962-2e46-e063-6294a90ac9a2
Type
HUMAN OTC DRUG
Nonproprietary name
Dimenhydrinate
Dosage form
TABLET
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-03
Substance
DIMENHYDRINATE
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
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 · 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
6dfc5cb4-af0c-56c9-e053-2a91aa0a5d56Available 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
69842-206-12Dimenhydrinate1 in 1 CARTONTABLET15
69842-206-12Dimenhydrinate12 in 1 BLISTER PACKTABLET125
69842-206-36Dimenhydrinate12 in 1 BLISTER PACKTABLET125
69842-206-36Dimenhydrinate3 in 1 CARTONTABLET35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-206DIMENHYDRINATE TABLET [CVS PHARMACY, INC.]5Current NDC, Legacy NDC, 4 package rows20241208_6dfc5cb4-af0c-56c9-e053-2a91aa0a5d56.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 TabletPSN6dfc5cb4-af0c-56c9-e053-2a91aa0a5d565
198603dimenhydrinate 50 MG Oral TabletSCD6dfc5cb4-af0c-56c9-e053-2a91aa0a5d565

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-206-12698420206121 BLISTER PACK in 1 CARTON (69842-206-12) / 12 TABLET in 1 BLISTER PACK1 blister pack2018-07-032029-02-28NoNoCurrent
69842-206-36698420206363 BLISTER PACK in 1 CARTON (69842-206-36) / 12 TABLET in 1 BLISTER PACK3 blister pack2018-07-032029-02-28NoNoCurrent