Diphenhydramine HCl

Product NDC
37835-519
11-digit product format
378350519
Labeler code
37835
Product ID
37835-519_359019a0-506d-34d2-e063-6294a90aee7c
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
BI-MART
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
Substance
DIPHENHYDRAMINE HCL
Active strength
50 mg/30mL
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 HCL50 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1248354

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37835-519-12Diphenhydramine HCl355 mL in 1 BOTTLELIQUID3551

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN2914504a-ed42-4168-9e5c-f49407ed5a301
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD2914504a-ed42-4168-9e5c-f49407ed5a301
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY2914504a-ed42-4168-9e5c-f49407ed5a301
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY2914504a-ed42-4168-9e5c-f49407ed5a301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37835-519-1237835051912355 mL in 1 BOTTLE (37835-519-12) 355 ml2025-05-01NoNoHistorical