FDA.reportPublic FDA data

Wal-Sleep Z

Product NDC
0363-0020
11-digit product format
003630020
Labeler code
0363
Product ID
0363-0020_4ae14104-5645-44ab-9e77-64bf3132c65c
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Walgreen Company
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-09-12
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/30mL
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0363-0020DDiscontinued by firm2026-08-11
excluded packagepackage0363-00200363-0020-02DDiscontinued by firm2026-08-11
excluded packagepackage0363-00200363-0020-45DDiscontinued by firm2026-08-11
excluded packagepackage0363-00200363-0020-96DDiscontinued by firm2026-08-11

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 · 4 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage0363-0020-02
excluded packagepackage0363-0020-96
excluded packagepackage0363-0020-45

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0020WAL-SLEEP Z NIGHTTIME (DIPHENHYDRAMINE HCL) SOLUTION [WALGREEN COMPANY]15Legacy NDC20240329_831b4d56-a6d9-44e9-b51a-709fe1b8eaaa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0020-0200363002002355 mL in 1 BOTTLE, PLASTIC (0363-0020-02) 355 ml2016-09-120000-00-00NoNoCurrent
0363-0020-4500363002045177 mL in 1 BOTTLE, PLASTIC (0363-0020-45) 177 ml2016-09-120000-00-00NoNoCurrent
0363-0020-96003630020962 BOTTLE, PLASTIC in 1 PACKAGE (0363-0020-96) > 355 mL in 1 BOTTLE, PLASTIC (0363-0020-02) 2016-09-120000-00-00NoNoCurrent