SLEEP AID

Product NDC
83059-0022
11-digit product format
830590022
Labeler code
83059
Product ID
83059-0022_4276ac9b-98c7-dfea-e063-6294a90adda9
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Shield Pharmaceuticals Corp
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-27
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
Rxcui1049909

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
83059-0022-1SLEEP AID1 in 1 CARTONCAPSULE, LIQUID FILLED14
83059-0022-1SLEEP AID12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83059-0022SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SHIELD PHARMACEUTICALS CORP]3Current NDC, 2 package rows20241228_625d10db-925e-443d-b362-65c83f471746.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN625d10db-925e-443d-b362-65c83f4717464
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD625d10db-925e-443d-b362-65c83f4717464

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83059-0022-1830590022011 BLISTER PACK in 1 CARTON (83059-0022-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2024-01-27NoNoCurrent