FDA.reportPublic FDA data

Anti-Itch

Product NDC
24385-210
Requested package NDC
24385-210-03
11-digit product format
243850210
Labeler code
24385
Product ID
24385-210_78575eb6-cbf4-4967-a519-2a9983495da1
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride and Zinc acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Amerisource Bergen
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2005-09-20
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
20 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage24385-21024385-210-03DDiscontinued by firm2026-10-12

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage24385-21024385-210-03IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…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
24385-210-032020-06-22C16284748780-19d75b9d0-bf56-f424-e053-dadaa90a57ceAnti-Itch Cream
24385-210-032020-01-31C16284748780-19d75b9d0-bf56-f424-e053-dadaa90a57ceAnti-Itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24385-210-03Anti-Itch1 in 1 CARTONCREAM14
24385-210-03Anti-Itch28.4 g in 1 TUBECREAM28.44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24385-210-03GM - Gram24385-2105b1ac1a3-18cd-4684-aa83-b0514a94698b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [AMERISOURCE BERGEN]1
Zinc acetateACTIVE INGREDIENTFM5526K07AANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [AMERISOURCE BERGEN]1
DiphenhydramineACTIVE MOIETY8GTS82S83MANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [AMERISOURCE BERGEN]1
Zinc CationACTIVE MOIETY13S1S8SF37ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [AMERISOURCE BERGEN]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [AMERISOURCE BERGEN]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [AMERISOURCE BERGEN]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [AMERISOURCE BERGEN]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [AMERISOURCE BERGEN]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [AMERISOURCE BERGEN]1
waterINACTIVE INGREDIENT059QF0KO0RANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [AMERISOURCE BERGEN]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24385-210ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [AMERISOURCE BERGEN]3Legacy NDC, 2 package rows20241105_4275c286-225d-4b03-bff0-8fca07959d7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN4275c286-225d-4b03-bff0-8fca07959d7c4
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD4275c286-225d-4b03-bff0-8fca07959d7c4
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY4275c286-225d-4b03-bff0-8fca07959d7c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24385-210-03243850210031 TUBE in 1 CARTON (24385-210-03) > 28.4 g in 1 TUBE1 tube2005-09-200000-00-00NoNoCurrent