MAXIMUM STRENGTH Nighttime Sleep Aid

Product NDC
51013-179
11-digit product format
510130179
Labeler code
51013
Product ID
51013-179_518b94dd-2b8b-4c42-ba6b-3ed2ddd3d196
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
PuraCap Pharmaceutical LLC
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-07-12
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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
51013-179-162025-01-30C16284748780-12cef2736-a1fc-d83d-e063-dadaa90ab31fMAXIMUM STRENGTH Nighttime Sleep-Aid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-179-16MAXIMUM STRENGTH Nighttime Sleep Aid1 in 1 CARTONCAPSULE, LIQUID FILLED12
51013-179-16MAXIMUM STRENGTH Nighttime Sleep Aid32 in 1 BOTTLECAPSULE, LIQUID FILLED322

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-179MAXIMUM STRENGTH NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]2Legacy NDC, 2 package rows20200103_b13970a6-85ee-46a0-85de-08bb1fe0b3d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNb13970a6-85ee-46a0-85de-08bb1fe0b3d92
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDb13970a6-85ee-46a0-85de-08bb1fe0b3d92
1020477diphenhydramine HCl 50 MG Oral CapsuleSYb13970a6-85ee-46a0-85de-08bb1fe0b3d92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51013-179-16510130179161 BOTTLE in 1 CARTON (51013-179-16) > 32 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2016-07-120000-00-00NoNoCurrent