FDA.reportPublic FDA data

NDC 58602-024-16 - AuroZzil 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
58602-024
Requested NDC
58602-024-16
Package NDCs from labels
58602-024-16, 58602-024-31, 58602-024-18
Manufacturer
Aurohealth LLC
Effective date
2020-11-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AuroZzil NIGHTTIME SLEEP-AID - Aurohealth LLCAurohealth LLC2020-11-13Human OTC Drug Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40AUROZZIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MAUROZZIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MAUROZZIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAUROZZIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
BERRYINACTIVE INGREDIENTFV3431923ZAUROZZIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAUROZZIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAUROZZIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SAUROZZIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IAUROZZIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AUROZZIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAUROZZIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAUROZZIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KAUROZZIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RAUROZZIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]1

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 140 of 206 · 4,117 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SANI-CLAWSANI-CLAWHomeland Industrial Supply2be875a1-0e9d-2e2a-e063-6394a90a15202025-01-17WarningsExact identifier
unii: 3K9958V90M
Percogesic Original StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLMedtech Products Inc.529974c2-0121-4892-8e47-c2c4475810912025-01-17WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HCL ORALEverpharm LLCd7aaf874-69ac-49cf-93be-6d4a38b9a5572025-01-16WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HCL 25 mgDIPHENHYDRAMINE HCLReliable 1 Laboratories LLC32f58cb3-941f-263b-e054-00144ff8d46c2025-01-15WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HCl 25 mgDIPHENHYDRAMINE HCLReliable 1 Laboratories LLC32fa40ad-fed5-586f-e054-00144ff88e882025-01-15WarningsExact identifier
unii: TC2D6JAD40
ROAME Moisturizing Hand Sanitizer Cloud 999ALCOHOL HAND SANITIZERRoame LLC2bb1003e-8e4c-8dd8-e063-6294a90ad37d2025-01-14WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLCMC Group Inc.dcca50e6-0935-401d-a23e-be4d1231dde92025-01-13WarningsExact identifier
unii: 3K9958V90M
Diphenhydramine HCLDIPHENHYDRAMINE HCLSDA Laboratories, Inc.437e6a13-a4ff-4f98-8973-042f224ee85e2025-01-13WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HCLDIPHENHYDRAMINE HCLSDA Laboratories, Inc.6a520986-1004-4ee6-9a47-1dfd90bb1b2c2025-01-13WarningsExact identifier
unii: TC2D6JAD40
Allergy Relief 25 mgDIPHENHYDRAMINE HCL 25MGUlai Health LLC751f13d4-c4d6-47a5-b40d-1563de08c0482025-01-12WarningsExact identifier
unii: TC2D6JAD40
SaniiSwabETHYL ALCOHOLPOLLEY MED LLC2ad08239-18ea-9ec9-e063-6394a90a3a542025-01-10WarningsExact identifier
unii: 3K9958V90M
AntibacterialALCOHOLHenry Schein Inc.87446203-1365-49b6-9346-62fb8ec783112025-01-10WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLHenry Schein, Inc.e80feb63-2c51-4164-806d-778e39e620e82025-01-10WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLHenry Schein, Inc.3b075cdc-509d-4259-99a2-0e219998949d2025-01-10WarningsExact identifier
unii: 3K9958V90M
Hand Guard Foaming Alcohol Instant Hand SanitizerALCOHOLWechem, Inc.2b60cd24-f0a9-5c54-e063-6394a90ab3502025-01-10WarningsExact identifier
unii: 3K9958V90M
ChemStation E3 Hand SanitizerETHANOLChemstation4a37ef06-b74b-1ed1-e054-00144ff8d46c2025-01-09WarningsExact identifier
unii: 3K9958V90M
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: XF417D3PSL
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Chain Drug Marketing Association Inc.2b48cb2f-e6bf-f9de-e063-6394a90a42d42025-01-09WarningsExact identifier
unii: TC2D6JAD40
SleepAid (Diphenhydramine HCL)DIPHENHYDRAMINE HCLAPNAR PHARMA LPfaaf5d51-d81d-3acc-e053-6294a90ae08f2025-01-09WarningsExact identifier
unii: TC2D6JAD40
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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