FDA.reportPublic FDA data

NIGHTTIME SLEEP AID

Product NDC
36800-654
Requested package NDC
36800-654-96
11-digit product format
368000654
Labeler code
36800
Product ID
36800-654_ee2806c0-83e0-02c5-e053-2a95a90a742f
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TopCo Associates LLC
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-10-10
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage36800-65436800-654-96IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-654-96NIGHTTIME SLEEP AID96 in 1 BOTTLECAPSULE, LIQUID FILLED966

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-654NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]6Legacy NDC, 1 package rows20241222_d9d0f660-c039-4657-9bea-af247cbfb648.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNd9d0f660-c039-4657-9bea-af247cbfb6486
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDd9d0f660-c039-4657-9bea-af247cbfb6486
1020477diphenhydramine HCl 50 MG Oral CapsuleSYd9d0f660-c039-4657-9bea-af247cbfb6486

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-654-963680006549696 CAPSULE, LIQUID FILLED in 1 BOTTLE (36800-654-96) 2019-10-100000-00-00NoNoCurrent