FDA.reportPublic FDA data

MAXIMUM STRENGTH Nighttime Sleep Aid

Product NDC
69842-836
Requested package NDC
69842-836-02
11-digit product format
698420836
Labeler code
69842
Product ID
69842-836_edc577bc-6f8e-f1b7-e053-2995a90a5084
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS PHARMACY
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-08-25
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 packagepackage69842-83669842-836-02IInactivated by FDA2026-10-12

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
69842-836-02MAXIMUM STRENGTH Nighttime Sleep Aid200 in 1 BOTTLECAPSULE, LIQUID FILLED2006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-836MAXIMUM STRENGTH NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CVS PHARMACY]6Legacy NDC, 1 package rows20250101_911b3bf5-500a-4c22-b21d-5ef52a05bbbc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN911b3bf5-500a-4c22-b21d-5ef52a05bbbc6
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD911b3bf5-500a-4c22-b21d-5ef52a05bbbc6
1020477diphenhydramine HCl 50 MG Oral CapsuleSY911b3bf5-500a-4c22-b21d-5ef52a05bbbc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-836-0269842083602200 CAPSULE, LIQUID FILLED in 1 BOTTLE (69842-836-02) 2021-08-250000-00-00NoNoCurrent