Night Time Sleep Aid

Product NDC
51013-129
11-digit product format
510130129
Labeler code
51013
Product ID
51013-129_75d266c7-980d-4844-86bf-3b4cba0a0f26
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
2016-05-05
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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
51013-129-022025-01-30C16284748780-12cef2736-8466-d83d-e063-dadaa90ab31fNight Time Sleep Aid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-129-02Night Time Sleep Aid12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122
51013-129-02Night Time Sleep Aid1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-129NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]2Legacy NDC, 2 package rows20191121_ac1ce01c-48e2-4734-9361-ff4d45b4b658.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNac1ce01c-48e2-4734-9361-ff4d45b4b6582
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDac1ce01c-48e2-4734-9361-ff4d45b4b6582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51013-129-02510130129021 BLISTER PACK in 1 CARTON (51013-129-02) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2016-05-050000-00-00NoNoCurrent