FDA.reportPublic FDA data

Good Neighbor Pharmacy Sleep Aid

Product NDC
24385-431
11-digit product format
243850431
Labeler code
24385
Product ID
24385-431_42f797b6-6442-4f87-bd3c-bb49aad8f11a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amerisource Bergen
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2001-04-14
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 productproduct24385-431DDiscontinued by firm2026-10-15
excluded packagepackage24385-43124385-431-26DDiscontinued by firm2026-10-15
excluded packagepackage24385-43124385-431-78DDiscontinued 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 · 33 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 packagepackage24385-431-26d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage24385-431-78d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage24385-431-26f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage24385-431-78f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage24385-431-262ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage24385-431-782ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage24385-431-26a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage24385-431-78a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage24385-431-26cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage24385-431-78cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage24385-431-26cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage24385-431-78cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage24385-431-26302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage24385-431-78302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage24385-431-26ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage24385-431-78ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage24385-431-260efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage24385-431-780efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage24385-431-26ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage24385-431-78ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage24385-431-26367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage24385-431-78367a005e9d99…383a685ebd0f…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24385-431-262024-01-30C16284748780-11030e365-1036-111a-e063-dadaa90a10e2Amerisource Bergen Nighttime Sleep Aid Drug Facts
24385-431-782024-01-30C16284748780-11030e365-1036-111a-e063-dadaa90a10e2Amerisource Bergen Nighttime Sleep Aid Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24385-431-26EA - Each24385-431f9e5132e-d155-4945-928f-897b3756ef6012012-07-24
24385-431-78EA - Each24385-431b27d50c7-0693-4dca-9796-d76fc004445412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40GOOD NEIGHBOR PHARMACY SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERISOURCE BERGEN]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MGOOD NEIGHBOR PHARMACY SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERISOURCE BERGEN]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPGOOD NEIGHBOR PHARMACY SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERISOURCE BERGEN]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGOOD NEIGHBOR PHARMACY SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERISOURCE BERGEN]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD NEIGHBOR PHARMACY SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERISOURCE BERGEN]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGOOD NEIGHBOR PHARMACY SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERISOURCE BERGEN]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD NEIGHBOR PHARMACY SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERISOURCE BERGEN]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD NEIGHBOR PHARMACY SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERISOURCE BERGEN]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD NEIGHBOR PHARMACY SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERISOURCE BERGEN]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGOOD NEIGHBOR PHARMACY SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERISOURCE BERGEN]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGOOD NEIGHBOR PHARMACY SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERISOURCE BERGEN]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD NEIGHBOR PHARMACY SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [AMERISOURCE BERGEN]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24385-431-26243850431262 BLISTER PACK in 1 CARTON (24385-431-26) > 12 TABLET in 1 BLISTER PACK2 blister pack2001-04-140000-00-00NoNoCurrent
24385-431-78243850431781 BOTTLE in 1 CARTON (24385-431-78) > 100 TABLET in 1 BOTTLE1 bottle2007-08-210000-00-00NoNoCurrent