FDA.reportPublic FDA data

NDC 71309-110-05 - Sleep-EZ Nighttime Sleep Aid

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
71309-110
Requested NDC
71309-110-05
Package NDCs from labels
71309-110-25, 71309-110-50, 71309-110-02, 71309-110-30, 71309-110-05, 71309-110-01, 71309-110-10
Manufacturer
Safrel Pharmaceuticals, LLC.
Effective date
2021-05-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sleep-EZ Nighttime Sleep AidSafrel Pharmaceuticals, LLC.2021-05-31HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
71309-110-02Sleep-EZ Nighttime Sleep Aid
71309-110-10Sleep-EZ Nighttime Sleep Aid
71309-110-25Sleep-EZ Nighttime Sleep Aid
71309-110-50Sleep-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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 182 · 3,631 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief ChildrensDIPHENHYDRAMINE HCLL.N.K. International, Inc.6ec5445b-a1f2-47ba-99f7-5a4a6d0c29e32026-08-10WarningsExact identifier
unii: TC2D6JAD40
Sleep AidDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)651b03a3-b85e-4028-a9f2-472bec16c8f42026-08-10WarningsExact identifier
unii: TC2D6JAD40
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
Severe Cold and Cough NighttimeACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEWinCo Foods, LLCdc56197c-c108-4b35-b791-dde5c3384ddd2026-08-07WarningsExact identifier
unii: TC2D6JAD40
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLC6fb6cfde-30a6-419c-973d-8abdc72611ed2026-08-07WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC887cabe5-46d0-4f4e-8f5a-2cfdbc157b582026-08-07WarningsExact identifier
rxcui: 1049630
unii: TC2D6JAD40
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLSalado Sales, Inc.aef30709-f33d-48ff-b2d4-0639ffbd1ffd2026-08-07WarningsExact identifier
unii: TC2D6JAD40
Winco Foods Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLCa1367804-37c9-4906-858f-8feeb748d8d32026-08-07WarningsExact identifier
unii: TC2D6JAD40
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECardinal Health, 110 dba Leader3ed7b8a1-012f-459d-878c-813b93d4673c2026-08-06Warnings, Adverse reactionsExact identifier
unii: TC2D6JAD40
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Sleep AidDIPHENHYDRAMINE HCLDOLGENCORP, LLC2bb3016a-2e03-43fe-a655-45d4ec872c792026-08-05WarningsExact identifier
rxcui: 1049630
unii: TC2D6JAD40
pain relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHARRIS TEETER0afb6181-d0b1-4845-8230-faabf1b997dc2026-08-05WarningsExact identifier
unii: TC2D6JAD40
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter8a3e3439-90ae-4fc9-8ff2-44b8363fa3382026-08-05WarningsExact identifier
unii: TC2D6JAD40
Nighttime Sleep Aid Alcohol FreeDIPHENHYDRAMINE HCLWal-Mart Stores Inc6e398d21-6cfa-4f9b-9219-0cd949e882662026-08-05WarningsExact identifier
unii: TC2D6JAD40
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
ValuRx Dye Free Allergy ReliefDIPHENHYDRAMINE HCL 25 MGShield Pharmaceuticals Corpca60a413-b02e-48ce-985d-4d415780c6792026-08-04WarningsExact identifier
unii: TC2D6JAD40
SurviveX Travel Med MODCONVENIENCE KITIntent Brands LLC522da86b-cfd7-dd20-e063-6394a90a51c62026-08-04WarningsExact identifier
rxcui: 1049630
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc150b68ba-3ed4-4533-9118-74e76eaf6e482026-08-04WarningsExact identifier
rxcui: 1049630
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.