FDA.reportPublic FDA data

Dramamine

Product NDC
67751-170
Requested package NDC
67751-170-02
11-digit product format
677510170
Labeler code
67751
Product ID
67751-170_9689d382-9ab8-b2ee-e053-2a95a90a9d3e
Type
HUMAN OTC DRUG
Nonproprietary name
DIMENHYDRINATE
Dosage form
TABLET
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-09-23
Marketing end
0000-00-00
Substance
DIMENHYDRINATE
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage67751-17067751-170-02IInactivated by FDA2026-10-12

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
67751-170-012025-01-30Dramamine
67751-170-022025-01-30Dramamine
67751-170-012023-03-15Dramamine
67751-170-022023-03-15Dramamine
67751-170-012023-01-30Dramamine
67751-170-022023-01-30Dramamine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-170-01Dramamine1 in 1 CARTONTABLET13
67751-170-01Dramamine2 in 1 POUCHTABLET23
67751-170-02Dramamine1 in 1 CARTONTABLET13
67751-170-02Dramamine4 in 1 POUCHTABLET43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-170DRAMAMINE (DIMENHYDRINATE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]3Legacy NDC, 4 package rows20230316_4139b5bf-2e49-40c3-9f4a-d8e15c044ead.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198603dimenhyDRINATE 50 MG Oral TabletPSN4139b5bf-2e49-40c3-9f4a-d8e15c044ead3
201716Dramamine 50 MG Oral TabletPSN4139b5bf-2e49-40c3-9f4a-d8e15c044ead3
201716dimenhydrinate 50 MG Oral Tablet [Dramamine]SBD4139b5bf-2e49-40c3-9f4a-d8e15c044ead3
198603dimenhydrinate 50 MG Oral TabletSCD4139b5bf-2e49-40c3-9f4a-d8e15c044ead3
201716Dramamine 50 MG Oral TabletSY4139b5bf-2e49-40c3-9f4a-d8e15c044ead3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-170-02677510170021 POUCH in 1 CARTON (67751-170-02) > 4 TABLET in 1 POUCH1 pouch2016-09-230000-00-00NoNoCurrent