Diphenhydramine HCl

Product NDC
0536-1214
11-digit product format
005361214
Labeler code
0536
Product ID
0536-1214_c0b8fd3b-609b-4b55-a447-670d19f77821
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rugby Laboratories
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-28
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
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
0536-1214-29Diphenhydramine HCl100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1214-29EA - Each0536-12149c8f0956-e693-4bd8-a017-a4e54219b29912019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1214DIPHENHYDRAMINE HCL TABLET, FILM COATED [RUGBY LABORATORIES]10Current NDC, Legacy NDC, 1 package rows20241023_6c4f280d-9a98-40c3-a459-4220cf34c313.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN6c4f280d-9a98-40c3-a459-4220cf34c31311
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD6c4f280d-9a98-40c3-a459-4220cf34c31311
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNbc7fe079-403d-1000-e053-2995a90a235f1
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDbc7fe079-403d-1000-e053-2995a90a235f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1214-2900536121429100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0536-1214-29) 2019-03-280000-00-00NoNoCurrent