FDA.reportPublic FDA data

childrens allergy relief

Product NDC
0363-1236
11-digit product format
003631236
Labeler code
0363
Product ID
0363-1236_d34dfdef-2d5f-46b5-84f6-b402d058375c
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Walgreen Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-29
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
childrens allergy relief
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
0363-1236-26childrens allergy relief118 mL in 1 BOTTLESOLUTION1182
0363-1236-26childrens allergy relief1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1236CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [WALGREEN COMPANY]2Current NDC, 2 package rows20240504_7848bb09-2af8-47f6-b32d-96635a750a55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN7848bb09-2af8-47f6-b32d-96635a750a552
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD7848bb09-2af8-47f6-b32d-96635a750a552
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY7848bb09-2af8-47f6-b32d-96635a750a552
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY7848bb09-2af8-47f6-b32d-96635a750a552
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY7848bb09-2af8-47f6-b32d-96635a750a552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-1236-26003631236261 BOTTLE in 1 CARTON (0363-1236-26) / 118 mL in 1 BOTTLE1 bottle2024-04-29NoNoCurrent