Sleep Aid

Product NDC
46122-754
11-digit product format
461220754
Labeler code
46122
Product ID
46122-754_4db2bd04-7556-4b3b-b76c-5f580b72e662
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Amerisource Bergen
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-14
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/30mL
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
Sleep Aid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1248354

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
46122-754-29Sleep Aid355 mL in 1 BOTTLE, PLASTICSOLUTION3556

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-754SLEEP AID (DIPHENHYDRAMINE HCL) SOLUTION [AMERISOURCE BERGEN]4Current NDC, 1 package rows20241109_8f1cb631-4633-4ef5-868e-48a46ab311a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN8f1cb631-4633-4ef5-868e-48a46ab311a46
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD8f1cb631-4633-4ef5-868e-48a46ab311a46
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY8f1cb631-4633-4ef5-868e-48a46ab311a46
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY8f1cb631-4633-4ef5-868e-48a46ab311a46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46122-754-2946122075429355 mL in 1 BOTTLE, PLASTIC (46122-754-29) 355 ml2023-09-14NoNoHistorical