FDA.reportPublic FDA data

Childrens Allergy Relief

Product NDC
59779-585
11-digit product format
597790585
Labeler code
59779
Product ID
59779-585_482f45fe-63a5-42a8-bf92-1d7744878c73
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-03-20
Marketing end
2028-01-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/1
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049900

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-585-07Childrens Allergy Relief6 in 1 CARTONTABLET, CHEWABLE620
59779-585-07Childrens Allergy Relief6 in 1 BLISTER PACKTABLET, CHEWABLE620
59779-585-44Childrens Allergy Relief3 in 1 CARTONTABLET, CHEWABLE320
59779-585-44Childrens Allergy Relief6 in 1 BLISTER PACKTABLET, CHEWABLE620

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-585-07EA - Each59779-58558858d83-af0a-43c1-9762-eb3ac1b7383312021-09-07
59779-585-44EA - Each59779-585dc6ff8c7-cfef-419c-92d4-ccad937207ac12017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
DEXTRATESINACTIVE INGREDIENTG263MI44RUCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
GRAPEINACTIVE INGREDIENT6X543N684KCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
MANNITOLINACTIVE INGREDIENT3OWL53L36ACHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-585CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [CVS PHARMACY]20Current NDC, Legacy NDC, 4 package rows20250430_8296049c-72fc-4200-9d45-c8e377314cf2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049900diphenhydrAMINE HCl 12.5 MG Chewable TabletPSN8296049c-72fc-4200-9d45-c8e377314cf220
1049900diphenhydramine hydrochloride 12.5 MG Chewable TabletSCD8296049c-72fc-4200-9d45-c8e377314cf220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-585-07597790585076 BLISTER PACK in 1 CARTON (59779-585-07) / 6 TABLET, CHEWABLE in 1 BLISTER PACK6 blister pack2009-03-202028-01-31NoNoCurrent
59779-585-44597790585443 BLISTER PACK in 1 CARTON (59779-585-44) / 6 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2009-03-202028-01-31NoNoCurrent