FDA.reportPublic FDA data

Childrens Dye Free Allergy Relief

Product NDC
11822-0918
11-digit product format
118220918
Labeler code
11822
Product ID
11822-0918_b91a2cbf-85a9-4010-af8e-ded66acc7be3
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
2023-05-01
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 Dye Free Allergy Relief
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40

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
11822-0918-1Childrens Dye Free Allergy Relief118 mL in 1 BOTTLE, PLASTICSOLUTION1184
11822-0918-1Childrens Dye Free Allergy Relief1 in 1 CARTONSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0918CHILDRENS DYE FREE ALLERGY RELIEF (DIPHENHYDRAMINE HCL) SOLUTION [RITE AID CORPORATION]4Current NDC, 2 package rows20250512_74ff4f0d-7952-4b74-b1b2-5a2beab91f7c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
11822-0918-1118220918011 BOTTLE, PLASTIC in 1 CARTON (11822-0918-1) / 118 mL in 1 BOTTLE, PLASTIC2023-05-01NoNoHistorical