FDA.reportPublic FDA data

Select Brand Itch Relief

Product NDC
15127-054
11-digit product format
151270054
Labeler code
15127
Product ID
15127-054_0bc49507-4263-3f8d-e054-00144ff88e88
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride and Zinc Acetate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Select Brand
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-07-11
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
0 g/10mL; g/10mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
15127-054-022020-01-31C16284748780-19d75b9d0-ddb6-f424-e053-dadaa90a57ceSelect Brand Itch Relief Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15127-054-02Select Brand Itch Relief59 mL in 1 BOTTLE, SPRAYSPRAY593

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40SELECT BRAND ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SPRAY [SELECT BRAND]3
ZINC ACETATEACTIVE INGREDIENTFM5526K07ASELECT BRAND ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SPRAY [SELECT BRAND]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MSELECT BRAND ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SPRAY [SELECT BRAND]3
ZINC CATIONACTIVE MOIETY13S1S8SF37SELECT BRAND ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SPRAY [SELECT BRAND]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MSELECT BRAND ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SPRAY [SELECT BRAND]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSELECT BRAND ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SPRAY [SELECT BRAND]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ESELECT BRAND ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SPRAY [SELECT BRAND]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSELECT BRAND ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SPRAY [SELECT BRAND]3
WATERINACTIVE INGREDIENT059QF0KO0RSELECT BRAND ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SPRAY [SELECT BRAND]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15127-054SELECT BRAND ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SPRAY [SELECT BRAND]3Legacy NDC, 1 package rows20150110_0bc49507-4262-3f8d-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053138diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SprayPSN0bc49507-4262-3f8d-e054-00144ff88e883
1053138diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SpraySCD0bc49507-4262-3f8d-e054-00144ff88e883
1053138diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SpraySY0bc49507-4262-3f8d-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
15127-054-021512700540259 mL in 1 BOTTLE, SPRAY59 mlHistorical