FDA.reportPublic FDA data

Dramamine

Product NDC
66715-9809
Requested package NDC
66715-9809-2
11-digit product format
667159809
Labeler code
66715
Product ID
66715-9809_27d73a65-c63e-1fd1-e063-6394a90a007e
Type
HUMAN OTC DRUG
Nonproprietary name
Dimenhydrinate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-05-10
Substance
DIMENHYDRINATE
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
Dramamine
Listing expiration
2026-12-31

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
309913Internal RxNorm lookup
602223Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
960a642b-ee7c-4e92-9b5f-930425682dacAvailable 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
66715-9809-1Dramamine2 in 1 POUCHTABLET, CHEWABLE27
66715-9809-1Dramamine1 in 1 CARTONTABLET, CHEWABLE17
66715-9809-2Dramamine2 in 1 CARTONTABLET, CHEWABLE27
66715-9809-2Dramamine2 in 1 POUCHTABLET, CHEWABLE27
66715-9809-7Dramamine25 in 1 BOX, UNIT-DOSETABLET, CHEWABLE257
66715-9809-7Dramamine2 in 1 POUCHTABLET, CHEWABLE27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9809DRAMAMINE (DIMENHYDRINATE) TABLET, CHEWABLE DRAMAMINE, TRAVEL BASIX (DIMENHYDRINATE) TABLET, CHEWABLE [LIL' DRUG STORE PRODUCTS, INC.]7Current NDC, Legacy NDC, 6 package rows20241127_960a642b-ee7c-4e92-9b5f-930425682dac.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 6 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Airmit AceDIMENHYDRINATESato Pharmaceutical Co., Ltd.a98d252d-4cfa-496a-ab2c-627f45f0d7d92023-12-01WarningsExact identifier
application number: M009
Meclizine HClMECLIZINE HYDROCHLORIDEBluePoint Laboratoriesd9cae5a6-8d4b-bdaf-e053-2995a90a7d442023-11-17WarningsExact identifier
application number: M009
ZenTrip Motion SicknessMECLIZINE HYDROCHLORIDESato Pharmaceutical Co., LTDbd86c4c7-b6f0-e3e8-e053-2995a90a44542023-11-03WarningsExact identifier
application number: M009
Travel-EaseMECLIZINE HCLGeri-Care Pharmaceutical Corpe3c64eb9-4972-29d9-e053-2a95a90a2a8a2023-10-25WarningsExact identifier
application number: M009
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d95240bb-02f2-3226-e053-2995a90afacd2022-03-03WarningsExact identifier
application number: M009
Allergy DyeFreeALLERGY DYEFREEAllegiant Health15736bb8-5a5b-489d-83ad-4cf34ec629562021-04-26WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATE 50MGAllegiant Health7b0aa993-f08f-4dff-a82d-f35b3ebe3cc12019-12-12WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309913dimenhyDRINATE 50 MG Chewable TabletPSN960a642b-ee7c-4e92-9b5f-930425682dac7
602223Dramamine 50 MG Chewable TabletPSN960a642b-ee7c-4e92-9b5f-930425682dac7
602223dimenhydrinate 50 MG Chewable Tablet [Dramamine]SBD960a642b-ee7c-4e92-9b5f-930425682dac7
309913dimenhydrinate 50 MG Chewable TabletSCD960a642b-ee7c-4e92-9b5f-930425682dac7
602223Dramamine 50 MG Chewable TabletSY960a642b-ee7c-4e92-9b5f-930425682dac7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66715-9809-2667159809022 POUCH in 1 CARTON (66715-9809-2) / 2 TABLET, CHEWABLE in 1 POUCH2 pouch2022-05-16NoNoCurrent