FDA.reportPublic FDA data

Aller-Ben

Product NDC
68196-829
Requested package NDC
68196-829-78
11-digit product format
681960829
Labeler code
68196
Product ID
68196-829_c2c77728-672d-4841-a6d2-687b4b91abbc
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sam's West Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-02-18
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 packagepackage68196-82968196-829-78DDiscontinued by firm2026-10-21

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
68196-829-78Aller-Ben600 in 1 BOTTLE, PLASTICTABLET, FILM COATED6008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68196-829-78EA - Each68196-829d005fb03-fe77-4007-a244-6e107bc803d012024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-829ALLER-BEN (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SAM'S WEST INC]7Legacy NDC, 1 package rows20240702_55d4f1c3-a97b-4b33-a392-7cab00b56de5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN55d4f1c3-a97b-4b33-a392-7cab00b56de58
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD55d4f1c3-a97b-4b33-a392-7cab00b56de58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68196-829-7868196082978600 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68196-829-78) 2020-02-180000-00-00NoNoCurrent