FDA.reportPublic FDA data

Anti-Itch

Product NDC
52000-023
Requested package NDC
52000-023-37
11-digit product format
520000023
Labeler code
52000
Product ID
52000-023_d886cfd3-5e21-6470-e053-2a95a90ac246
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride and Zinc Acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-04-15
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
0 g/g; g/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
2023-12-31
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 packagepackage52000-02352000-023-37IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52000-023-372025-07-29C16284748780-19d75b9d0-197b-f424-e053-dadaa90a57ceAnti-Itch Cream
52000-023-372022-02-21C16284748780-19d75b9d0-197b-f424-e053-dadaa90a57ceAnti-Itch Cream
52000-023-372020-01-31C16284748780-19d75b9d0-197b-f424-e053-dadaa90a57ceAnti-Itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-023-37Anti-Itch1 in 1 BOXCREAM14
52000-023-39Anti-Itch28 g in 1 TUBECREAM284

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07AANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
ZINC CATIONACTIVE MOIETY13S1S8SF37ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
PEG-20 STEARATEINACTIVE INGREDIENTNBX892EA57ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-023ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]4Legacy NDC, 2 package rows20241212_79fd6b63-5fd4-4ab0-81df-e9d582984ace.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN79fd6b63-5fd4-4ab0-81df-e9d582984ace4
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD79fd6b63-5fd4-4ab0-81df-e9d582984ace4
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY79fd6b63-5fd4-4ab0-81df-e9d582984ace4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-023-37520000023371 TUBE in 1 BOX (52000-023-37) > 28 g in 1 TUBE (52000-023-39) 1 tube2022-02-140000-00-00NoNoCurrent