FDA.reportPublic FDA data

CVS Itch Relief

Product NDC
69842-400
11-digit product format
698420400
Labeler code
69842
Product ID
69842-400_0cf95509-d4ee-83fb-e063-6394a90a4e08
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine Hydrochloride and Zinc Acetate
Dosage form
LOTION
Route
TOPICAL
Labeler
CVS Pharmacy
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
Substance
PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active strength
10; 1 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CVS Itch Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL
ZINC ACETATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5, FM5526K07A
Rxcui1234546

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-400-96CVS Itch Relief177 mL in 1 BOTTLE, PLASTICLOTION1777

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-400-96ML - Milliliter69842-400177b05ee-038b-426c-bc39-35fb63793cd712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-400CVS ITCH RELIEF (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [CVS PHARMACY]7Current NDC, Legacy NDC, 1 package rows20231221_c60cfbf2-6788-43dc-b23a-e3433b7f3265.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSNc60cfbf2-6788-43dc-b23a-e3433b7f32657
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCDc60cfbf2-6788-43dc-b23a-e3433b7f32657
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSYc60cfbf2-6788-43dc-b23a-e3433b7f32657

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-400-9669842040096177 mL in 1 BOTTLE, PLASTIC (69842-400-96) 177 ml2008-01-010000-00-00NoNoCurrent