Sleep Aid

Product NDC
50804-410
11-digit product format
508040410
Labeler code
50804
Product ID
50804-410_e298ad65-81f2-44b3-ab94-f0aba0855203
Type
HUMAN OTC DRUG
Nonproprietary name
Sleep Aid
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Good Sense
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-18
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
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 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
50804-410-38Sleep Aid1 in 1 CARTONCAPSULE, LIQUID FILLED11
50804-410-38Sleep Aid32 in 1 BOTTLECAPSULE, LIQUID FILLED321

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-410-38EA - Each50804-410b26ec46d-d1df-40d6-aa95-f64e8c482eed12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-410SLEEP AID CAPSULE, LIQUID FILLED [GOOD SENSE]1Current NDC, 2 package rows20240619_c1481fad-9b32-4f84-8f03-4b4fa5edc866.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNc1481fad-9b32-4f84-8f03-4b4fa5edc8661
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDc1481fad-9b32-4f84-8f03-4b4fa5edc8661
1020477diphenhydramine HCl 50 MG Oral CapsuleSYc1481fad-9b32-4f84-8f03-4b4fa5edc8661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50804-410-38508040410381 BOTTLE in 1 CARTON (50804-410-38) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-06-18NoNoCurrent