FDA.reportPublic FDA data

Westlake Itch Relief

Product NDC
82895-715
11-digit product format
828950715
Labeler code
82895
Product ID
82895-715_0c419012-62b2-e052-e063-6394a90ab7ad
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl, Zinc Acetate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Westlake HB Pharma LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-01
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
Westlake Itch Relief
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82895-715-60Westlake Itch Relief59 mL in 1 BOTTLE, SPRAYSPRAY591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82895-715WESTLAKE ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [WESTLAKE HB PHARMA LLC]1Current NDC, 1 package rows20231212_0c416ba6-b01f-0609-e063-6294a90ae2a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053138diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SprayPSN0c416ba6-b01f-0609-e063-6294a90ae2a11
1053138diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SpraySCD0c416ba6-b01f-0609-e063-6294a90ae2a11
1053138diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SpraySY0c416ba6-b01f-0609-e063-6294a90ae2a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82895-715-608289507156059 mL in 1 BOTTLE, SPRAY (82895-715-60) 59 ml2023-10-01NoNoHistorical