FDA.reportPublic FDA data

Diphenhydramine Oral Liquid

Product NDC
57237-305
11-digit product format
572370305
Labeler code
57237
Product ID
57237-305_952598aa-cb50-400d-85da-e8acab206e5a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
M009.50
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-19
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/5mL
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 Oral Liquid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049906

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
57237-305-12Diphenhydramine Oral Liquid118 mL in 1 BOTTLELIQUID1182
57237-305-16Diphenhydramine Oral Liquid473 mL in 1 BOTTLELIQUID4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-305-12ML - Milliliter57237-305aa05f7f2-8b91-47a3-95ec-9e97e34984c812023-02-06
57237-305-16ML - Milliliter57237-3059a997a67-be7c-4cef-a004-9a8394d8822812023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-305DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RISING PHARMA HOLDINGS, INC.]2Current NDC, Legacy NDC, 2 package rows20241020_d8462e6f-a9fb-4701-97e2-d81a47f3e196.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNd8462e6f-a9fb-4701-97e2-d81a47f3e1962
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDd8462e6f-a9fb-4701-97e2-d81a47f3e1962
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYd8462e6f-a9fb-4701-97e2-d81a47f3e1962
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYd8462e6f-a9fb-4701-97e2-d81a47f3e1962
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYd8462e6f-a9fb-4701-97e2-d81a47f3e1962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-305-1257237030512118 mL in 1 BOTTLE (57237-305-12) 118 ml2022-12-190000-00-00NoNoCurrent
57237-305-1657237030516473 mL in 1 BOTTLE (57237-305-16) 473 ml2022-12-190000-00-00NoNoCurrent