Nighttime Sleep-Aid

Product NDC
46122-695
11-digit product format
461220695
Labeler code
46122
Product ID
46122-695_518f947e-eb37-5fad-e063-6294a90a9656
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
AMERISOURCE BERGEN
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nighttime Sleep-Aid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1020477

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
46122-695-72Nighttime Sleep-Aid1 in 1 CARTONCAPSULE, LIQUID FILLED14
46122-695-72Nighttime Sleep-Aid60 in 1 BOTTLECAPSULE, LIQUID FILLED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-695-72EA - Each46122-695c84d5d5f-4b8c-4d7d-b8ac-cdf3ad5ebfb512023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-695NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [AMERISOURCE BERGEN]3Current NDC, Legacy NDC, 2 package rows20231011_ca052b38-de38-7bf0-e053-2995a90a4e85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNca052b38-de38-7bf0-e053-2995a90a4e854
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDca052b38-de38-7bf0-e053-2995a90a4e854
1020477diphenhydramine HCl 50 MG Oral CapsuleSYca052b38-de38-7bf0-e053-2995a90a4e854

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-695-72461220695721 BOTTLE in 1 CARTON (46122-695-72) > 60 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-07-150000-00-00NoNoCurrent