Betr sleep aid

Product NDC
80267-431
11-digit product format
802670431
Labeler code
80267
Product ID
80267-431_44342978-6b80-4300-b448-3b872a26bcdf
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Live Betr LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-25
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Betr sleep aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049630

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80267-431-672024-01-30C16284748780-11030e365-5d81-111a-e063-dadaa90a10e2Live Betr LLC Sleep Aid Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80267-431-67Betr sleep aid2 in 1 BLISTER PACKTABLET, FILM COATED24
80267-431-67Betr sleep aid24 in 1 CARTONTABLET, FILM COATED244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80267-431BETR SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIVE BETR LLC]4Current NDC, Legacy NDC, 2 package rows20240724_8c2d5514-62c1-4e98-8412-20534365b934.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN8c2d5514-62c1-4e98-8412-20534365b9344
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD8c2d5514-62c1-4e98-8412-20534365b9344

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80267-431-678026704316724 BLISTER PACK in 1 CARTON (80267-431-67) / 2 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2021-01-250000-00-00NoNoCurrent