FDA.reportPublic FDA data

Topcare ZZZ Sleep

Product NDC
36800-507
Requested package NDC
36800-507-53
11-digit product format
368000507
Labeler code
36800
Product ID
36800-507_8b5a98f7-db89-4c16-a7a7-cd7405488cfc
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Topco Associates LLC
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-01-28
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-50736800-507-53DDiscontinued 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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage36800-50736800-507-53DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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 INGREDIENTTC2D6JAD40TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MTOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]4
GELATININACTIVE INGREDIENT2G86QN327LTOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-507TOPCARE ZZZ SLEEP (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]10Legacy NDC20241106_4304584b-df01-4a77-96e2-a2b96184da54.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-507-53368000507536 BLISTER PACK in 1 CARTON (36800-507-53) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK6 blister pack2014-01-280000-00-00NoNoCurrent