FDA.reportPublic FDA data

Extra Strength Itch Relief

Product NDC
83324-302
11-digit product format
833240302
Labeler code
83324
Product ID
83324-302_42f3fe19-b76d-2a12-e063-6394a90afd7f
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl and Zinc Acetate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Chain Drug Marketing Association Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-06
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
20; 1 mg/g; mg/g
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Extra Strength Itch Relief
Listing expiration
2026-12-31

Active Ingredients#

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

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
83324-302-27Extra Strength Itch Relief76 g in 1 CANSPRAY763

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-302EXTRA STRENGTH ITCH RELIEF (DIPHENHYDRAMINE HCL AND ZINC ACETATE) SPRAY [CHAIN DRUG MARKETING ASSOCIATION INC]2Current NDC, 1 package rows20241213_1a2997bc-7741-e658-e063-6394a90af6fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053138diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SprayPSN1a2997bc-7741-e658-e063-6394a90af6fd3
1053138diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SpraySCD1a2997bc-7741-e658-e063-6394a90af6fd3
1053138diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SpraySY1a2997bc-7741-e658-e063-6394a90af6fd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-302-278332403022776 g in 1 CAN (83324-302-27) 76 g2024-06-06NoNoHistorical