AuroZzil NIGHTTIME SLEEP-AID

Product NDC
58602-024
Requested package NDC
58602-024-31
11-digit product format
586020024
Labeler code
58602
Product ID
58602-024_cbc30b87-696f-4fd5-bd75-3271a1c15b47
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Aurohealth LLC
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-05-15
Marketing end
2022-05-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/30mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58602-02458602-024-31DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-024-31586020024312 BOTTLE in 1 CARTON (58602-024-31) > 354 mL in 1 BOTTLE (58602-024-16) 2 bottle2015-05-152022-05-01NoNoCurrent