allergy

Product NDC
42507-379
11-digit product format
425070379
Labeler code
42507
Product ID
42507-379_fb9454f6-8b77-4736-86d6-ab0e423b0077
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
HyVee Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1992-11-11
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
allergy
Listing expiration
2027-12-31

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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-379-00allergy118 mL in 1 BOTTLESOLUTION1185
42507-379-26allergy1 in 1 CARTONSOLUTION15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]2
SORBITOLINACTIVE INGREDIENT506T60A25RALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]2
WATERINACTIVE INGREDIENT059QF0KO0RALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN75b19163-db1c-42fc-8bbb-364be16b9b2f5
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD75b19163-db1c-42fc-8bbb-364be16b9b2f5
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY75b19163-db1c-42fc-8bbb-364be16b9b2f5
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY75b19163-db1c-42fc-8bbb-364be16b9b2f5
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY75b19163-db1c-42fc-8bbb-364be16b9b2f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-379-0042507037900118 mL in 1 BOTTLE118 mlHistorical
42507-379-26425070379261 BOTTLE in 1 CARTON (42507-379-26) / 118 mL in 1 BOTTLE (42507-379-00) 1 bottle1992-11-11NoNoHistorical