FDA.reportPublic FDA data

Childrens Allergy Relief

Product NDC
11822-0379
11-digit product format
118220379
Labeler code
11822
Product ID
11822-0379_5713d7dd-1e5c-49ef-a91b-9131f9aa5510
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Rite Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-05
Marketing end
2027-01-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Allergy Relief

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
11822-0379-0Childrens Allergy Relief118 mL in 1 BOTTLESOLUTION1183
11822-0379-0Childrens Allergy Relief1 in 1 CARTONSOLUTION13
11822-0379-1Childrens Allergy Relief1 in 1 CARTONSOLUTION13
11822-0379-1Childrens Allergy Relief237 mL in 1 BOTTLESOLUTION2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0379CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) SOLUTION [RITE AID CORPORATION]2Current NDC, 4 package rows20240426_d9f26677-ddef-4098-b564-9aa5734e088b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNd9f26677-ddef-4098-b564-9aa5734e088b3
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDd9f26677-ddef-4098-b564-9aa5734e088b3
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYd9f26677-ddef-4098-b564-9aa5734e088b3
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYd9f26677-ddef-4098-b564-9aa5734e088b3
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYd9f26677-ddef-4098-b564-9aa5734e088b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0379-0118220379001 BOTTLE in 1 CARTON (11822-0379-0) / 118 mL in 1 BOTTLE1 bottle2023-04-052027-01-31NoNoHistorical
11822-0379-1118220379011 in 1 CARTONHistorical