NightTime Sleep Aid

Product NDC
53187-236
11-digit product format
531870236
Labeler code
53187
Product ID
53187-236_7c8a719a-2182-425f-8211-a7f91eb7b923
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
LIVE BETTER (The Great Atlantic & Pacific Tea Company)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-02-01
Marketing end
2021-01-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 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 productproduct53187-236DDiscontinued by firm2026-10-15
excluded packagepackage53187-23653187-236-32DDiscontinued 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 packagepackage53187-236-32d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53187-236-32f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53187-236-322ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53187-236-32a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53187-236-32cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53187-236-32cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53187-236-32302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53187-236-32ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53187-236-320efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53187-236-32ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53187-236-32367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53187-236-32557ba5c1ecfa…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 AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [LIVE BETTER (THE GREAT ATLANTIC & PACIFIC TEA COMPANY)]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MNIGHTTIME SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [LIVE BETTER (THE GREAT ATLANTIC & PACIFIC TEA COMPANY)]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHTTIME SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [LIVE BETTER (THE GREAT ATLANTIC & PACIFIC TEA COMPANY)]1
GELATININACTIVE INGREDIENT2G86QN327LNIGHTTIME SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [LIVE BETTER (THE GREAT ATLANTIC & PACIFIC TEA COMPANY)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIGHTTIME SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [LIVE BETTER (THE GREAT ATLANTIC & PACIFIC TEA COMPANY)]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPNIGHTTIME SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [LIVE BETTER (THE GREAT ATLANTIC & PACIFIC TEA COMPANY)]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIGHTTIME SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [LIVE BETTER (THE GREAT ATLANTIC & PACIFIC TEA COMPANY)]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUNIGHTTIME SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [LIVE BETTER (THE GREAT ATLANTIC & PACIFIC TEA COMPANY)]1
SORBITOLINACTIVE INGREDIENT506T60A25RNIGHTTIME SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [LIVE BETTER (THE GREAT ATLANTIC & PACIFIC TEA COMPANY)]1
WATERINACTIVE INGREDIENT059QF0KO0RNIGHTTIME SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [LIVE BETTER (THE GREAT ATLANTIC & PACIFIC TEA COMPANY)]1