FDA.reportPublic FDA data

Equaline Night Time Sleep Aid

Product NDC
41163-119
11-digit product format
411630119
Labeler code
41163
Product ID
41163-119_b2950c50-077d-4375-86f9-7e7b0c369296
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Supervalu Inc
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-03-07
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct41163-119DDiscontinued by firm2026-10-15
excluded packagepackage41163-11941163-119-53DDiscontinued by firm2026-10-15
excluded packagepackage41163-11941163-119-62DDiscontinued 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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41163-119-53d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41163-119-62d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41163-119-53f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41163-119-62f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41163-119-622ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41163-119-62a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41163-119-62cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41163-119-62cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41163-119-62302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41163-119-62ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41163-119-620efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41163-119-62ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41163-119-62367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41163-119-62557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-119-53EA - Each41163-11939da1b32-ddfc-4971-964f-094d2d84788212023-01-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40EQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [SUPERVALU INC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MEQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [SUPERVALU INC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [SUPERVALU INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [SUPERVALU INC]2
GELATININACTIVE INGREDIENT2G86QN327LEQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [SUPERVALU INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [SUPERVALU INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [SUPERVALU INC]2
WATERINACTIVE INGREDIENT059QF0KO0REQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [SUPERVALU INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-119EQUALINE NIGHT TIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [UNITED NATURAL FOODS, INC. DBA UNFI]7Legacy NDC20241106_0ba32f9b-6a84-4797-b082-86684b0899c8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-119-53411630119536 BLISTER PACK in 1 CARTON (41163-119-53) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK6 blister pack2014-03-070000-00-00NoNoCurrent
41163-119-624116301196212 BLISTER PACK in 1 CARTON (41163-119-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK12 blister pack2014-03-070000-00-00NoNoCurrent