Nighttime Sleep Easy

Product NDC
59726-400
11-digit product format
597260400
Labeler code
59726
Product ID
59726-400_93fc81b6-c17b-4716-825f-cf9be4346105
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HCL
Dosage form
TABLET
Route
ORAL
Labeler
P & L Development, LLC
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-12-04
Marketing end
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59726-400DDiscontinued by firm2026-10-15
excluded packagepackage59726-40059726-400-12DDiscontinued 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 · 24 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 packagepackage59726-400-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59726-400-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59726-400-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59726-400-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59726-400-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59726-400-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59726-400-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59726-400-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59726-400-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59726-400-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59726-400-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59726-400-12557ba5c1ecfa…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 INGREDIENTTC2D6JAD40NIGHTTIME SLEEP EASY (DIPHENHYDRAMINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MNIGHTTIME SLEEP EASY (DIPHENHYDRAMINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPNIGHTTIME SLEEP EASY (DIPHENHYDRAMINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNIGHTTIME SLEEP EASY (DIPHENHYDRAMINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNIGHTTIME SLEEP EASY (DIPHENHYDRAMINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NIGHTTIME SLEEP EASY (DIPHENHYDRAMINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHTTIME SLEEP EASY (DIPHENHYDRAMINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIGHTTIME SLEEP EASY (DIPHENHYDRAMINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIGHTTIME SLEEP EASY (DIPHENHYDRAMINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NIGHTTIME SLEEP EASY (DIPHENHYDRAMINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIGHTTIME SLEEP EASY (DIPHENHYDRAMINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNIGHTTIME SLEEP EASY (DIPHENHYDRAMINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIGHTTIME SLEEP EASY (DIPHENHYDRAMINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]2