FDA.reportPublic FDA data

Quality Choice Dye Free Cherry Childrens Allergy Relief

Product NDC
83324-016
11-digit product format
833240016
Labeler code
83324
Product ID
83324-016_302ca7b5-f65c-4187-bbd6-f482be6e63c1
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Chain Drug Marketing Association Inc.
Application
part341
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-18
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
Quality Choice Dye Free Cherry 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-016-04Quality Choice Dye Free Cherry Childrens Allergy Relief1 in 1 CARTONLIQUID11
83324-016-04Quality Choice Dye Free Cherry Childrens Allergy Relief120 mL in 1 BOTTLELIQUID1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-016QUALITY CHOICE DYE FREE CHERRY CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [CHAIN DRUG MARKETING ASSOCIATION INC.]1Current NDC, 2 package rows20240320_302ca7b5-f65c-4187-bbd6-f482be6e63c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN302ca7b5-f65c-4187-bbd6-f482be6e63c11
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD302ca7b5-f65c-4187-bbd6-f482be6e63c11
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY302ca7b5-f65c-4187-bbd6-f482be6e63c11
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY302ca7b5-f65c-4187-bbd6-f482be6e63c11
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY302ca7b5-f65c-4187-bbd6-f482be6e63c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-016-04833240016041 BOTTLE in 1 CARTON (83324-016-04) / 120 mL in 1 BOTTLE1 bottle2024-03-18NoNoHistorical