CareOne Nighttime Sleep Aid

Product NDC
41520-052
Requested package NDC
41520-052-53
11-digit product format
415200052
Labeler code
41520
Product ID
41520-052_e45bc005-c56a-474f-a13b-366a7b2ab824
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
American Sales Company
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41520-05241520-052-53DDiscontinued 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 packagepackage41520-05241520-052-53DDiscontinued 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#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-052CAREONE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [AMERICAN SALES COMPANY]7Legacy NDC20241106_b3dd331c-6d0b-43c8-90e7-0525d95aa889.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-052-53415200052536 BLISTER PACK in 1 CARTON (41520-052-53) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK6 blister pack2014-01-280000-00-00NoNoCurrent