Diphenhydramine HCl

Product NDC
37835-852
11-digit product format
378350852
Labeler code
37835
Product ID
37835-852_371d6967-1b61-30cc-e063-6394a90a56cc
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Bi-Mart
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
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
Diphenhydramine HCl
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1085945

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
37835-852-50Diphenhydramine HClMaximum Strength50 in 1 BOTTLETABLET501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085945diphenhydrAMINE HCl 50 MG Oral TabletPSNb89c80aa-27ae-4fce-b574-8ee64bbae2751
1085945diphenhydramine hydrochloride 50 MG Oral TabletSCDb89c80aa-27ae-4fce-b574-8ee64bbae2751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37835-852-503783508525050 TABLET in 1 BOTTLE (37835-852-50) 50 tablet2025-05-01NoNoCurrent