Sleep Aid

Product NDC
36800-236
11-digit product format
368000236
Labeler code
36800
Product ID
36800-236_f257db1d-5399-4d71-82d7-3d8b19ed2c40
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-02-01
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 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 productproduct36800-236DDiscontinued by firm2026-10-15
excluded packagepackage36800-23636800-236-03DDiscontinued by firm2026-10-15
excluded packagepackage36800-23636800-236-64DDiscontinued 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 · 36 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 packagepackage36800-236-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage36800-236-64d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36800-236-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36800-236-64f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36800-236-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36800-236-642ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36800-236-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36800-236-64a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36800-236-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36800-236-64cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36800-236-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36800-236-64cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36800-236-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36800-236-64302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36800-236-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36800-236-64ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage36800-236-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage36800-236-640efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage36800-236-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage36800-236-64ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage36800-236-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage36800-236-64367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage36800-236-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage36800-236-64557ba5c1ecfa…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 INGREDIENTTC2D6JAD40SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MSLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]1
GELATININACTIVE INGREDIENT2G86QN327LSLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPSLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUSLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]1
SORBITOLINACTIVE INGREDIENT506T60A25RSLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]1
WATERINACTIVE INGREDIENT059QF0KO0RSLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-236-03368000236031 BOTTLE, PLASTIC in 1 BOX (36800-236-03) > 32 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2014-02-010000-00-00NoNoCurrent
36800-236-64368000236641 BOTTLE, PLASTIC in 1 BOX (36800-236-64) > 64 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2014-02-010000-00-00NoNoCurrent