FDA.reportPublic FDA data

Itch Relief

Product NDC
55910-295
11-digit product format
559100295
Labeler code
55910
Product ID
55910-295_4c0f56dd-647f-bdfa-e063-6394a90aebb8
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl, Zinc Acetate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Old East Main Co.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-07-14
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
20; 1 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], 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
Itch Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE20 mg/mL
ZINC ACETATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40, FM5526K07A
Rxcui1053138

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-295-20Itch Relief59 mL in 1 BOTTLE, SPRAYSPRAY5917

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [DOLGENCORP, LLC]3
ZINC ACETATEACTIVE INGREDIENTFM5526K07AITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [DOLGENCORP, LLC]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [DOLGENCORP, LLC]3
ZINC CATIONACTIVE MOIETY13S1S8SF37ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [DOLGENCORP, LLC]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [DOLGENCORP, LLC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [DOLGENCORP, LLC]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [DOLGENCORP, LLC]3
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [DOLGENCORP, LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [DOLGENCORP, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-295ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [OLD EAST MAIN CO]15Current NDC, Legacy NDC, 1 package rows20240915_6d87547f-bf4c-4dda-bd9d-32b576afd805.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053138diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SprayPSN6d87547f-bf4c-4dda-bd9d-32b576afd80517
1053138diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SpraySCD6d87547f-bf4c-4dda-bd9d-32b576afd80517
1053138diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SpraySY6d87547f-bf4c-4dda-bd9d-32b576afd80517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-295-205591002952059 mL in 1 BOTTLE, SPRAY (55910-295-20) 59 ml2010-07-140000-00-00NoNoCurrent