EZ Nite Sleep

Product NDC
55319-225
Requested package NDC
55319-225-12
11-digit product format
553190225
Labeler code
55319
Product ID
55319-225_f18dbbe7-9534-4883-83d5-8e7e78afc2a4
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-10-30
Marketing end
2021-12-30
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
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 packagepackage55319-22555319-225-12DDiscontinued by firm2026-10-15

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 INGREDIENTTC2D6JAD40EZ NITE SLEEP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MEZ NITE SLEEP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEZ NITE SLEEP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEZ NITE SLEEP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
GELATININACTIVE INGREDIENT2G86QN327LEZ NITE SLEEP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEZ NITE SLEEP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEZ NITE SLEEP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUEZ NITE SLEEP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
SORBITOLINACTIVE INGREDIENT506T60A25REZ NITE SLEEP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEZ NITE SLEEP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
WATERINACTIVE INGREDIENT059QF0KO0REZ NITE SLEEP NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-225-12553190225121 BLISTER PACK in 1 CARTON (55319-225-12) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2013-10-302021-12-30NoNoCurrent