FDA.reportPublic FDA data

Sleep-EZ Nighttime Sleep Aid

Product NDC
71309-110
11-digit product format
713090110
Labeler code
71309
Product ID
71309-110_c3a6790e-f944-66f0-e053-2a95a90a9812
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl 25 mg
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Safrel Pharmaceuticals, LLC.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-06-01
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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
71309-110-022023-01-30C16284748780-1f386c64a-12b1-0266-e053-dadaa90a7c1aSleep-EZ Nighttime Sleep Aid
71309-110-102023-01-30C16284748780-1f386c64a-12b1-0266-e053-dadaa90a7c1aSleep-EZ Nighttime Sleep Aid
71309-110-252023-01-30C16284748780-1f386c64a-12b1-0266-e053-dadaa90a7c1aSleep-EZ Nighttime Sleep Aid
71309-110-502023-01-30C16284748780-1f386c64a-12b1-0266-e053-dadaa90a7c1aSleep-EZ Nighttime Sleep Aid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71309-110-01Sleep-EZ Nighttime Sleep Aid1000 in 1 BOTTLETABLET, COATED10003
71309-110-02Sleep-EZ Nighttime Sleep Aid2 in 1 POUCHTABLET, COATED23
71309-110-05Sleep-EZ Nighttime Sleep Aid500 in 1 BOTTLETABLET, COATED5003
71309-110-10Sleep-EZ Nighttime Sleep Aid100 in 1 BOTTLETABLET, COATED1003
71309-110-25Sleep-EZ Nighttime Sleep Aid25 in 1 BOXTABLET, COATED253
71309-110-25Sleep-EZ Nighttime Sleep Aid2 in 1 POUCHTABLET, COATED23
71309-110-30Sleep-EZ Nighttime Sleep Aid30 in 1 BOTTLETABLET, COATED303
71309-110-30Sleep-EZ Nighttime Sleep Aid1 in 1 CARTONTABLET, COATED13
71309-110-50Sleep-EZ Nighttime Sleep Aid50 in 1 BOXTABLET, COATED503
71309-110-50Sleep-EZ Nighttime Sleep Aid2 in 1 POUCHTABLET, COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71309-110SLEEP-EZ NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET, COATED [SAFREL PHARMACEUTICALS, LLC.]3Legacy NDC, 10 package rows20210613_87537ba2-f4d7-8ea3-e053-2a95a90acc38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN87537ba2-f4d7-8ea3-e053-2a95a90acc383
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD87537ba2-f4d7-8ea3-e053-2a95a90acc383

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71309-110-01713090110011000 BOTTLE in 1 BOTTLE (71309-110-01) > 500 BOTTLE in 1 BOTTLE (71309-110-05) > 30 CARTON in 1 BOTTLE (71309-110-30) > 1 TABLET, COATED in 1 CARTON1000 bottle2017-06-010000-00-00NoNoCurrent
71309-110-02713090110022 POUCH in 1 POUCH (71309-110-02) > 2 TABLET, COATED in 1 POUCH2 pouch2017-06-010000-00-00NoNoCurrent
71309-110-0571309011005500 in 1 BOTTLEHistorical
71309-110-1071309011010100 BOTTLE in 1 BOTTLE (71309-110-10) > 1000 BOTTLE in 1 BOTTLE (71309-110-01) > 500 BOTTLE in 1 BOTTLE (71309-110-05) > 30 CARTON in 1 BOTTLE (71309-110-30) > 1 TABLET, COATED in 1 CARTON100 bottle2017-06-010000-00-00NoNoCurrent
71309-110-257130901102525 POUCH in 1 BOX (71309-110-25) > 2 TABLET, COATED in 1 POUCH25 pouch2017-06-010000-00-00NoNoCurrent
71309-110-307130901103030 in 1 BOTTLEHistorical
71309-110-507130901105050 POUCH in 1 BOX (71309-110-50) > 2 TABLET, COATED in 1 POUCH50 pouch2017-06-010000-00-00NoNoCurrent