FDA.reportPublic FDA data

Itch Relief Cream

Product NDC
68016-163
11-digit product format
680160163
Labeler code
68016
Product ID
68016-163_29b74830-5473-c90b-e063-6294a90a4e72
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Acetate 0.1%, Diphenhydramine hydrochloride 2%
Dosage form
CREAM
Route
TOPICAL
Labeler
Pharmacy Value Alliance LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-07-19
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
2; .1 g/100g; g/100g
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
Itch Relief Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE2 g/100g
ZINC ACETATE.1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40, FM5526K07A
Rxcui1087026

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
68016-163-012023-05-09C16284748780-1ba0f9c33-41c7-a910-e053-dadaa90a0b85Itch Relief Cream
68016-163-012023-01-30C16284748780-1ba0f9c33-41c7-a910-e053-dadaa90a0b85Itch Relief Cream
68016-163-012021-08-10C16284748780-1ba0f9c33-41c7-a910-e053-dadaa90a0b85Itch Relief Cream
68016-163-012021-01-29C16284748780-1ba0f9c33-41c7-a910-e053-dadaa90a0b85Itch Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-163-01Itch Relief Cream28 g in 1 TUBECREAM288
68016-163-01Itch Relief Cream1 in 1 BOXCREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-163ITCH RELIEF CREAM (ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%) CREAM [PHARMACY VALUE ALLIANCE LLC]8Current NDC, Legacy NDC, 2 package rows20241222_37fe6d82-adee-4f58-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN37fe6d82-adee-4f58-e054-00144ff88e888
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD37fe6d82-adee-4f58-e054-00144ff88e888
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY37fe6d82-adee-4f58-e054-00144ff88e888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-163-01680160163011 TUBE in 1 BOX (68016-163-01) / 28 g in 1 TUBE1 tube2016-09-010000-00-00NoNoCurrent