Diphenhydramine HCl 25mg

Product NDC
69168-002
11-digit product format
691680002
Labeler code
69168
Product ID
69168-002_36c028e5-005a-42eb-958c-9fed406827b3
Type
HUMAN OTC DRUG
Nonproprietary name
Sleep Aid
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Allegiant Health
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-23
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
Diphenhydramine HCl 25mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049630

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
69168-002-93Diphenhydramine HCl 25mg24 in 1 CARTONTABLET, COATED244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-002DIPHENHYDRAMINE HCL 25MG (SLEEP AID) TABLET, COATED [ALLEGIANT HEALTH]4Current NDC, Legacy NDC, 1 package rows20231020_2890e4ba-d642-437d-8a86-24996a74e027.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2890e4ba-d642-437d-8a86-24996a74e0274
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2890e4ba-d642-437d-8a86-24996a74e0274

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69168-002-936916800029324 TABLET, COATED in 1 CARTON (69168-002-93) 2021-11-230000-00-00NoNoCurrent