FDA.reportPublic FDA data

Sleep-Aid Chewables

Product NDC
69842-958
Requested package NDC
69842-958-44
11-digit product format
698420958
Labeler code
69842
Product ID
69842-958_9513ade0-1e0b-435b-8cdd-ad08449bc631
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
CVS PHARMACY
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-07-31
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 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 packagepackage69842-95869842-958-44DDiscontinued by firm2026-10-15

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-958-44Sleep-Aid ChewablesNighttime6 in 1 BLISTER PACKTABLET, CHEWABLE69
69842-958-44Sleep-Aid ChewablesNighttime3 in 1 CARTONTABLET, CHEWABLE39

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-958SLEEP-AID CHEWABLES NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [CVS PHARMACY]9Legacy NDC, 2 package rows20250512_d6579eed-6a53-4287-bf3e-431121dc0f83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2046528diphenhydrAMINE HCl 25 MG Chewable TabletPSNd6579eed-6a53-4287-bf3e-431121dc0f839
2046528diphenhydramine hydrochloride 25 MG Chewable TabletSCDd6579eed-6a53-4287-bf3e-431121dc0f839
2046528diphenhydramine HCl 25 MG Chewable TabletSYd6579eed-6a53-4287-bf3e-431121dc0f839

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-958-44698420958443 BLISTER PACK in 1 CARTON (69842-958-44) > 6 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2018-07-310000-00-00NoNoCurrent