Sleep Aid

Product NDC
69168-431
11-digit product format
691680431
Labeler code
69168
Product ID
69168-431_8f729339-eda6-456a-bdc5-445eff09ff66
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Allegiant Health
Application
M011
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-21
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
69168-431-03Sleep Aid250 in 1 BOTTLECAPSULE, LIQUID FILLED2504
69168-431-86Sleep Aid12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124
69168-431-86Sleep Aid1 in 1 CARTONCAPSULE, LIQUID FILLED14
69168-431-96Sleep Aid96 in 1 BOTTLECAPSULE, LIQUID FILLED964

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-431SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH]4Current NDC, Legacy NDC, 4 package rows20250515_9746911a-36bc-45eb-adfd-e96439d7a865.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN9746911a-36bc-45eb-adfd-e96439d7a8654
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD9746911a-36bc-45eb-adfd-e96439d7a8654

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-431-0369168043103250 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-431-03) 2023-04-30NoNoCurrent
69168-431-86691680431861 BLISTER PACK in 1 CARTON (69168-431-86) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2021-09-210000-00-00NoNoCurrent
69168-431-966916804319696 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-431-96) 2021-09-210000-00-00NoNoCurrent