Nighttime Sleep-Aid

Product NDC
11788-026
11-digit product format
117880026
Labeler code
11788
Product ID
11788-026_5c8aefee-6c86-ba92-e053-2a91aa0a3a82
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
AiPing Pharmaceutical, Inc.
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-01-31
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/21
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11788-026DDiscontinued by firm2026-10-05
excluded productproduct11788-026DDiscontinued by firm2026-10-05
excluded packagepackage11788-02611788-026-12DDiscontinued by firm2026-10-05
excluded packagepackage11788-02611788-026-00DDiscontinued by firm2026-10-05

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 · 48 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11788-026-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11788-026-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11788-026-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11788-026-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11788-026-002ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11788-026-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11788-026-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11788-026-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11788-026-00cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11788-026-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11788-026-00cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11788-026-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11788-026-00302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11788-026-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11788-026-00ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11788-026-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11788-026-000efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11788-026-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11788-026-00ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11788-026-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11788-026-00367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11788-026-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11788-026-00557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11788-026-12557ba5c1ecfa…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-AID SOFTGEL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL INC.]1
DiphenhydramineACTIVE MOIETY8GTS82S83MNIGHTTIME SLEEP-AID SOFTGEL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL INC.]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDNIGHTTIME SLEEP-AID SOFTGEL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL INC.]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOANIGHTTIME SLEEP-AID SOFTGEL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LNIGHTTIME SLEEP-AID SOFTGEL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXNIGHTTIME SLEEP-AID SOFTGEL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNIGHTTIME SLEEP-AID SOFTGEL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHTTIME SLEEP-AID SOFTGEL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL INC.]1
sorbitolINACTIVE INGREDIENT506T60A25RNIGHTTIME SLEEP-AID SOFTGEL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL INC.]1
waterINACTIVE INGREDIENT059QF0KO0RNIGHTTIME SLEEP-AID SOFTGEL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11788-026-00117880026001 BAG in 1 BOX (11788-026-00) > 20000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2015-01-310000-00-00NoNoCurrent
11788-026-12117880026121 BLISTER PACK in 1 CARTON (11788-026-12) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2015-01-310000-00-00NoNoCurrent