FDA.reportPublic FDA data

Dermamine

Product NDC
67234-023
Requested package NDC
67234-023-01
11-digit product format
672340023
Labeler code
67234
Product ID
67234-023_8a8a28e4-f72c-41e2-b190-3ca26b7c89c4
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE and ZINC ACETATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Natureplex LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-03-01
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE; ZINC ACETATE
Active strength
0 mg/g; U/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage67234-02367234-023-01IInactivated 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
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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
67234-023-01Dermamine Extra Strength Itch Stopping1 in 1 BOXCREAM13
67234-023-01Dermamine Extra Strength Itch Stopping35 g in 1 TUBECREAM353

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINEACTIVE INGREDIENT8GTS82S83MDERMAMINE EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE AND ZINC ACETATE) CREAM [NATUREPLEX LLC]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07ADERMAMINE EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE AND ZINC ACETATE) CREAM [NATUREPLEX LLC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDERMAMINE EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE AND ZINC ACETATE) CREAM [NATUREPLEX LLC]1
ZINC CATIONACTIVE MOIETY13S1S8SF37DERMAMINE EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE AND ZINC ACETATE) CREAM [NATUREPLEX LLC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SDERMAMINE EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE AND ZINC ACETATE) CREAM [NATUREPLEX LLC]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWDERMAMINE EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE AND ZINC ACETATE) CREAM [NATUREPLEX LLC]1
GLYCERYL 1-STEARATEINACTIVE INGREDIENT258491E1RZDERMAMINE EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE AND ZINC ACETATE) CREAM [NATUREPLEX LLC]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSDERMAMINE EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE AND ZINC ACETATE) CREAM [NATUREPLEX LLC]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPDERMAMINE EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE AND ZINC ACETATE) CREAM [NATUREPLEX LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDERMAMINE EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE AND ZINC ACETATE) CREAM [NATUREPLEX LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MDERMAMINE EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE AND ZINC ACETATE) CREAM [NATUREPLEX LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDERMAMINE EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE AND ZINC ACETATE) CREAM [NATUREPLEX LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RDERMAMINE EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE AND ZINC ACETATE) CREAM [NATUREPLEX LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-023DERMAMINE EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE AND ZINC ACETATE) CREAM [NATUREPLEX LLC]3Legacy NDC, 2 package rows20250101_ede192d1-5a2d-472c-8bd2-3966b26cb8f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSNede192d1-5a2d-472c-8bd2-3966b26cb8f53
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCDede192d1-5a2d-472c-8bd2-3966b26cb8f53
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSYede192d1-5a2d-472c-8bd2-3966b26cb8f53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67234-023-01672340023011 TUBE in 1 BOX (67234-023-01) > 35 g in 1 TUBE1 tube2014-03-010000-00-00NoNoCurrent