FDA.reportPublic FDA data

allergy relief

Product NDC
41163-585
11-digit product format
411630585
Labeler code
41163
Product ID
41163-585_63f7d288-decf-44cd-8e08-9af3ced4eaa3
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-03-20
Marketing end
2027-04-30
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
allergy relief
Brand name suffix
Childrens

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
41163-585-44allergy reliefChildrens6 in 1 BLISTER PACKTABLET, CHEWABLE616
41163-585-44allergy reliefChildrens3 in 1 CARTONTABLET, CHEWABLE316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-585-44EA - Each41163-585ca10f597-7781-4fb3-964c-1c0075e02a1412023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [SUPERVALU INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [SUPERVALU INC.]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [SUPERVALU INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [SUPERVALU INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [SUPERVALU INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [SUPERVALU INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-585ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [UNITED NATURAL FOODS, INC. DBA UNFI]15Current NDC, Legacy NDC, 2 package rows20240927_e34d8bf5-e12e-453c-93ea-9c7988c4f13d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049900diphenhydrAMINE HCl 12.5 MG Chewable TabletPSNe34d8bf5-e12e-453c-93ea-9c7988c4f13d16
1049900diphenhydramine hydrochloride 12.5 MG Chewable TabletSCDe34d8bf5-e12e-453c-93ea-9c7988c4f13d16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-585-44411630585443 BLISTER PACK in 1 CARTON (41163-585-44) / 6 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2009-03-202027-04-30NoNoCurrent