EZ Nite Sleep

Product NDC
63868-014
11-digit product format
638680014
Labeler code
63868
Product ID
63868-014_ac8f2a89-b672-489c-8675-07fefd575d7a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-03-11
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-014-242020-01-31C16284748780-19d75b9d0-5734-f424-e053-dadaa90a57ceDRUG FACTS
63868-014-482020-01-31C16284748780-19d75b9d0-5734-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-014-24EZ Nite SleepNighttime Sleep-Aid12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED125
63868-014-24EZ Nite SleepNighttime Sleep-Aid2 in 1 CARTONCAPSULE, LIQUID FILLED25
63868-014-48EZ Nite SleepNighttime Sleep-Aid4 in 1 CARTONCAPSULE, LIQUID FILLED45
63868-014-48EZ Nite SleepNighttime Sleep-Aid12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED125

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40EZ NITE SLEEP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MEZ NITE SLEEP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEZ NITE SLEEP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEZ NITE SLEEP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5
GELATININACTIVE INGREDIENT2G86QN327LEZ NITE SLEEP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEZ NITE SLEEP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEZ NITE SLEEP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5
SORBITANINACTIVE INGREDIENT6O92ICV9RUEZ NITE SLEEP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5
SORBITOLINACTIVE INGREDIENT506T60A25REZ NITE SLEEP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEZ NITE SLEEP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5
WATERINACTIVE INGREDIENT059QF0KO0REZ NITE SLEEP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-014EZ NITE SLEEP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5Legacy NDC, 4 package rows20131015_f85f73a2-9300-4b9b-89ab-f0d389d79c3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNf85f73a2-9300-4b9b-89ab-f0d389d79c3c5
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDf85f73a2-9300-4b9b-89ab-f0d389d79c3c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63868-014-246386800142412 in 1 BLISTER PACKHistorical
63868-014-48638680014484 in 1 CARTONHistorical