FDA.reportPublic FDA data

Diphenhydramine HCl Oral Solution

Product NDC
57237-318
11-digit product format
572370318
Labeler code
57237
Product ID
57237-318_deb36161-32a5-4e95-9837-fd12ca2c3778
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl Oral
Dosage form
SOLUTION
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
M009.50
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-15
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/10mL
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 Oral Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049906

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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
57237-318-01Diphenhydramine HCl Oral Solution10 mL in 1 CUP, UNIT-DOSESOLUTION103
57237-318-11Diphenhydramine HCl Oral Solution100 in 1 BOX, UNIT-DOSESOLUTION1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-318DIPHENHYDRAMINE HCL ORAL SOLUTION (DIPHENHYDRAMINE HCL ORAL) SOLUTION [RISING PHARMA HOLDINGS, INC.]2Current NDC, 2 package rows20241019_8f0ba9e5-a31d-4d77-8155-c16c7e74edef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN8f0ba9e5-a31d-4d77-8155-c16c7e74edef3
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD8f0ba9e5-a31d-4d77-8155-c16c7e74edef3
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY8f0ba9e5-a31d-4d77-8155-c16c7e74edef3
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY8f0ba9e5-a31d-4d77-8155-c16c7e74edef3
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY8f0ba9e5-a31d-4d77-8155-c16c7e74edef3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-318-015723703180110 mL in 1 CUP, UNIT-DOSE10 mlHistorical
57237-318-1157237031811100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-318-11) / 10 mL in 1 CUP, UNIT-DOSE (57237-318-01) 2023-12-15NoNoCurrent