Quality Choice Anti-itch Medicated

Product NDC
63868-420
11-digit product format
638680420
Labeler code
63868
Product ID
63868-420_01f80cbb-3c3f-738f-e063-6394a90a5ed4
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine and Pramoxine Hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-03-25
Substance
PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength
10; 80 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
Quality Choice Anti-itch Medicated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL
ZINC OXIDE80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5, SOI2LOH54Z

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
63868-420-96Quality Choice Anti-itch Medicated177 mL in 1 BOTTLE, PLASTICLOTION1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-420QUALITY CHOICE ANTI-ITCH MEDICATED (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKETING ASSOCIATION INC]4Current NDC, Legacy NDC, 1 package rows20231221_5e07f26f-cfb6-57f9-e053-2991aa0a2008.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-420-9663868042096177 mL in 1 BOTTLE, PLASTIC (63868-420-96) 177 ml2017-11-130000-00-00NoNoCurrent