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 134 of 206 · 4,117 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.dcfc08a0-ecd6-42d3-9ff2-e68d5317152f2025-02-27WarningsExact identifier
unii: 3K9958V90M
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: 3K9958V90M
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
COCONUT SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.fe347d07-496a-468a-bc38-d47b0f22c4332025-02-25WarningsExact identifier
unii: 3K9958V90M
CITRUS SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.64b2fef3-8d06-471d-b950-d4c355119dfa2025-02-25WarningsExact identifier
unii: 3K9958V90M
LAVENDER SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.0e5e21c3-9ee5-44be-988a-f82ac95230592025-02-25WarningsExact identifier
unii: 3K9958V90M
ALOE SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.aacde143-ecf1-47ce-ada3-8e74551d06592025-02-25WarningsExact identifier
unii: 3K9958V90M
EUCALYPTUS SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.068ed8c0-1fff-42dd-a217-684201c160232025-02-25WarningsExact identifier
unii: 3K9958V90M
SHEA BUTTER SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.669451fa-7557-4ef5-a668-fe4fea1f0c9b2025-02-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Crayola HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.def18e33-0a6b-40f8-a771-fcae1e6a1c822025-02-25WarningsExact identifier
unii: 3K9958V90M
Smart Care SPIDER-MAN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.db147cc8-6323-428b-b506-8ab7211cb3e62025-02-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Hot Wheels HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.046d534c-1bde-439c-9a90-8713aaada1a12025-02-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Barbie HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e9acb658-946d-405c-ad41-8b52542998bd2025-02-25WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLUniversal Synergetics, Inc0dd6884c-935f-4523-b19a-201b7a8666fc2025-02-24WarningsExact identifier
unii: 3K9958V90M
DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDEFresenius Kabi USA, LLCfc574e74-1fdc-4a61-a1ed-492ae43faed22025-02-21Warnings, Adverse reactionsExact identifier
unii: TC2D6JAD40
Genexa Acetaminophen PM Extra StrengthACETAMINOPHENGenexa Inc.d82cf6f3-a291-ca2b-e053-2a95a90a6de12025-02-20WarningsExact identifier
unii: TC2D6JAD40
Childrens AllergyDIPHENHYDRAMINE HCLGenexa Inc.e880b8d7-61c3-41cc-e053-2995a90aaaeb2025-02-20WarningsExact identifier
unii: TC2D6JAD40
FEELSHION Glycolic Acid Exfoliating Face PadsPROPYLENE GLYCOL,ARGININE,LACTIC ACID,SALICYLIC ACID,GLYCOLIC ACIDBeijing JUNGE Technology Co., Ltd.2e79678c-1ce4-25cf-e063-6394a90a133c2025-02-19WarningsExact identifier
unii: 6DC9Q167V3
meijer NIGHTTIME Sleep Aid SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bede4cd-bf55-8b84-e063-6394a90aa5c92025-02-19WarningsExact identifier
unii: TC2D6JAD40
Pain Reliever PMACETAMINOPHEN DIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)4897d1df-4fb3-46e2-bbf0-847e964dca0a2025-02-18WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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