FDA.reportPublic FDA data

Sleep Aid

Product NDC
46122-651
11-digit product format
461220651
Labeler code
46122
Product ID
46122-651_2d8a61fe-d753-42a5-bb9b-91d53244e551
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amerisource Bergen
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-29
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-651-62Sleep Aid12 in 1 BLISTER PACKTABLET, FILM COATED128
46122-651-62Sleep Aid2 in 1 CARTONTABLET, FILM COATED28
46122-651-78Sleep Aid1 in 1 CARTONTABLET, FILM COATED18
46122-651-78Sleep Aid100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-651-62EA - Each46122-651e4deb95c-d554-4463-b2bc-7a6d850c1d4b12021-07-15
46122-651-78EA - Each46122-65150fb5ecc-9149-4e02-8549-59871985a6a512023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-651SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [AMERISOURCE BERGEN]7Current NDC, Legacy NDC, 4 package rows20240711_147adc14-ca7c-45f5-9925-ea569edbfe96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN147adc14-ca7c-45f5-9925-ea569edbfe968
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD147adc14-ca7c-45f5-9925-ea569edbfe968

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-651-62461220651622 BLISTER PACK in 1 CARTON (46122-651-62) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2020-07-290000-00-00NoNoCurrent
46122-651-78461220651781 BOTTLE, PLASTIC in 1 CARTON (46122-651-78) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2020-07-290000-00-00NoNoCurrent