FDA.reportPublic FDA data

Diphenhydramine HCl and Zinc Acetate

Product NDC
53943-030
Requested package NDC
53943-030-76
11-digit product format
539430030
Labeler code
53943
Product ID
53943-030_c790a6de-ec7f-67c6-e053-2995a90afb90
Type
HUMAN OTC DRUG
Nonproprietary name
Extra Strength Itch Relief
Dosage form
SPRAY
Route
TOPICAL
Labeler
Discount Drug Mart
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-03-25
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
2 g/76g; g/76g
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53943-03053943-030-76IInactivated by FDA2026-10-05

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
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
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
53943-030-76Diphenhydramine HCl and Zinc Acetate76 g in 1 CANSPRAY766

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-030DIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF) SPRAY [DISCOUNT DRUG MART]6Legacy NDC, 1 package rows20241208_d4ef917b-a9a8-4102-97d3-d7233393e622.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053138diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SprayPSNd4ef917b-a9a8-4102-97d3-d7233393e6226
1053138diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SpraySCDd4ef917b-a9a8-4102-97d3-d7233393e6226
1053138diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SpraySYd4ef917b-a9a8-4102-97d3-d7233393e6226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-030-765394300307676 g in 1 CAN (53943-030-76) 76 g2013-03-250000-00-00NoNoCurrent