FDA.reportPublic FDA data

Diphenhydramine HCL 25 mg

Product NDC
69618-025
11-digit product format
696180025
Labeler code
69618
Product ID
69618-025_2bc8473d-acff-da1d-e063-6394a90ae0d4
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Reliable 1 Laboratories LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-01
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 25 mg
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-025-012023-03-29C16284748780-1f386c649-ba1c-0266-e053-dadaa90a7c1aDiphenhydramine HCL 25 mg Caplets
69618-025-012023-01-30C16284748780-1f386c649-ba1c-0266-e053-dadaa90a7c1aDiphenhydramine HCL 25 mg Caplets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-025-01Diphenhydramine HCL 25 mg100 in 1 BOTTLE, PLASTICTABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-025-01EA - Each69618-0255a05a5a2-1dba-42d7-b99f-8bd149fcc9c912016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-025DIPHENHYDRAMINE HCL 25 MG (DIPHENHYDRAMINE HCL) TABLET [RELIABLE 1 LABORATORIES LLC]7Current NDC, Legacy NDC, 1 package rows20250117_32f58cb3-941f-263b-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN32f58cb3-941f-263b-e054-00144ff8d46c7
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD32f58cb3-941f-263b-e054-00144ff8d46c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69618-025-0169618002501100 TABLET in 1 BOTTLE, PLASTIC (69618-025-01) 100 tablet2015-11-010000-00-00NoNoCurrent