FDA.reportPublic FDA data

CVS Health Childrens Allergy Relief

Product NDC
59779-793
11-digit product format
597790793
Labeler code
59779
Product ID
59779-793_1ccf7ffb-3b53-48a4-acc6-e52f249fcc05
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
CVS Pharmacy,Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-09-07
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
CVS Health 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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-793-10CVS Health Childrens Allergy Relief10 in 1 CARTONLIQUID102
59779-793-10CVS Health Childrens Allergy Relief5 mL in 1 VIAL, SINGLE-DOSELIQUID52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-793CVS HEALTH CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY,INC.]2Current NDC, Legacy NDC, 2 package rows20171231_dbd8c221-8409-4851-a6b4-c9f5e8e346e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNdbd8c221-8409-4851-a6b4-c9f5e8e346e72
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDdbd8c221-8409-4851-a6b4-c9f5e8e346e72
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYdbd8c221-8409-4851-a6b4-c9f5e8e346e72
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYdbd8c221-8409-4851-a6b4-c9f5e8e346e72
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYdbd8c221-8409-4851-a6b4-c9f5e8e346e72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59779-793-105977907931010 VIAL, SINGLE-DOSE in 1 CARTON (59779-793-10) / 5 mL in 1 VIAL, SINGLE-DOSE2015-09-070000-00-00NoNoCurrent