Premier Value Nighttime Sleep Aid Softgels

Product NDC
68016-218
11-digit product format
680160218
Labeler code
68016
Product ID
68016-218_165a2e49-73d2-481f-b4ce-d6597c23e009
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Chain Drug Consortium
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-11-14
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/21
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
68016-218-252020-01-31C16284748780-19d75b9d0-160c-f424-e053-dadaa90a57cePREMIER VALUE SLEEP-AID SOFTGELS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-218-25Premier Value Nighttime Sleep Aid Softgels2 in 1 BLISTER PACKCAPSULE, GELATIN COATED22
68016-218-25Premier Value Nighttime Sleep Aid Softgels12 in 1 CARTONCAPSULE, GELATIN COATED122

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40PREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [CHAIN DRUG CONSORTIUM]1
DiphenhydramineACTIVE MOIETY8GTS82S83MPREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [CHAIN DRUG CONSORTIUM]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [CHAIN DRUG CONSORTIUM]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAPREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [CHAIN DRUG CONSORTIUM]1
gelatinINACTIVE INGREDIENT2G86QN327LPREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [CHAIN DRUG CONSORTIUM]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXPREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [CHAIN DRUG CONSORTIUM]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [CHAIN DRUG CONSORTIUM]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1APREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [CHAIN DRUG CONSORTIUM]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [CHAIN DRUG CONSORTIUM]1
sorbitolINACTIVE INGREDIENT506T60A25RPREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [CHAIN DRUG CONSORTIUM]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [CHAIN DRUG CONSORTIUM]1
waterINACTIVE INGREDIENT059QF0KO0RPREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [CHAIN DRUG CONSORTIUM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-218PREMIER VALUE NIGHTTIME SLEEP AID SOFTGELS (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [CHAIN DRUG CONSORTIUM]2Legacy NDC, 2 package rows20160615_a6e94bea-7348-4b09-9244-9ef7b31a16b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNa6e94bea-7348-4b09-9244-9ef7b31a16b42
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDa6e94bea-7348-4b09-9244-9ef7b31a16b42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68016-218-25680160218252 in 1 BLISTER PACKHistorical