FDA.reportPublic FDA data

GoodSense Anti-Itch

Product NDC
50804-064
11-digit product format
508040064
Labeler code
50804
Product ID
50804-064_2f38bdfc-6134-1b8a-e063-6294a90a6703
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl, Zinc Acetate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Geiss, Destin & Dunn, Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
2; .1 g/100mL; g/100mL
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
GoodSense Anti-Itch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE2 g/100mL
ZINC ACETATE.1 g/100mL

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
50804-064-02GoodSense Anti-Itch59 mL in 1 TUBESPRAY591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-064GOODSENSE ANTI-ITCH (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [GEISS, DESTIN & DUNN, INC]1Current NDC, 1 package rows20250501_2f38bdfc-6135-1b8a-e063-6294a90a6703.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053138diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SprayPSN2f38bdfc-6135-1b8a-e063-6294a90a67031
1053138diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SpraySCD2f38bdfc-6135-1b8a-e063-6294a90a67031
1053138diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SpraySY2f38bdfc-6135-1b8a-e063-6294a90a67031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50804-064-025080400640259 mL in 1 TUBE (50804-064-02) 59 ml2025-05-01NoNoHistorical