FDA.reportPublic FDA data

Allergy Relief

Product NDC
41250-599
11-digit product format
412500599
Labeler code
41250
Product ID
41250-599_9cb3d0e1-84fe-4443-9861-f9f3e8af1066
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Meijer Distribution Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-04-25
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
13 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct41250-599DDiscontinued by firm2026-10-16
excluded packagepackage41250-59941250-599-44DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
41250-599-44Allergy ReliefChildrens6 in 1 BLISTER PACKTABLET, CHEWABLE615
41250-599-44Allergy ReliefChildrens3 in 1 CARTONTABLET, CHEWABLE315

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [MEIJER]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [MEIJER]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [MEIJER]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [MEIJER]2
DEXTRATESINACTIVE INGREDIENTG263MI44RUALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [MEIJER]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [MEIJER]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [MEIJER]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [MEIJER]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [MEIJER]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-599ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [MEIJER DISTRIBUTION INC]14Legacy NDC, 2 package rows20250512_5d6998f7-51ea-4422-9944-45b075343e57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049900diphenhydrAMINE HCl 12.5 MG Chewable TabletPSN5d6998f7-51ea-4422-9944-45b075343e5715
1049900diphenhydramine hydrochloride 12.5 MG Chewable TabletSCD5d6998f7-51ea-4422-9944-45b075343e5715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-599-44412500599443 BLISTER PACK in 1 CARTON (41250-599-44) > 6 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2011-04-250000-00-00NoNoCurrent