Nighttime Sleep Aid

Product NDC
83059-0109
11-digit product format
830590109
Labeler code
83059
Product ID
83059-0109_4355a7ad-83b9-7edc-e063-6294a90a92e5
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
2025-11-11
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
Nighttime 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
83059-0109-8Nighttime Sleep Aid8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED82
83059-0109-8Nighttime Sleep Aid1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN60d62a23-d5e4-425c-8604-af8aabfb6ad42
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD60d62a23-d5e4-425c-8604-af8aabfb6ad42
1020477diphenhydramine HCl 50 MG Oral CapsuleSY60d62a23-d5e4-425c-8604-af8aabfb6ad42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83059-0109-8830590109081 BLISTER PACK in 1 CARTON (83059-0109-8) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2025-11-11NoNoCurrent