Dicopanol

Product NDC
43093-104
11-digit product format
430930104
Labeler code
43093
Product ID
43093-104_24eae96d-b218-3c03-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
KIT
Route
ORAL
Labeler
Fusion Pharmaceuticals LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2010-02-08
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43093-104-012020-01-31C16284748780-19d75b9d1-038d-f424-e053-dadaa90a57ceDICOPANOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43093-104-01Dicopanol1 in 1 KITKIT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43093-104-01ML - Milliliter43093-10405fb80af-d2d8-4875-a16b-6971995a432612014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40DICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]4
DiphenhydramineACTIVE MOIETY8GTS82S83MDICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]4
GlycerinINACTIVE INGREDIENTPDC6A3C0OXDICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]4
GLYCYRRHIZIN, AMMONIATEDINACTIVE INGREDIENT3VRD35U26CDICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]4
MelatoninINACTIVE INGREDIENTJL5DK93RCLDICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]4
OrangeINACTIVE INGREDIENT5EVU04N5QUDICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]4
PineappleINACTIVE INGREDIENT2A88ZO081ODICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]4
Potassium SorbateINACTIVE INGREDIENT1VPU26JZZ4DICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]4
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUDICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]4
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRDICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]4
Stevia LeafINACTIVE INGREDIENT6TC6NN0876DICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]4
WaterINACTIVE INGREDIENT059QF0KO0RDICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]4
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEDICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]4
XylitolINACTIVE INGREDIENTVCQ006KQ1EDICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43093-104DICOPANOL (DIPHENHYDRAMINE HYDROCHLORIDE) KIT [FUSION PHARMACEUTICALS LLC]5Legacy NDC, 1 package rows20151204_76c12e0d-735b-44d1-aa82-73e3f3a09d1b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43093-104-01430930104011 in 1 KITHistorical