Quality Choice Anti-Itch Clear

Product NDC
63868-097
11-digit product format
638680097
Labeler code
63868
Product ID
63868-097_0d9a5cf8-de3a-bacf-e063-6394a90a761a
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Acetate and Pramoxine Hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Chain Drug Market Association
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-03-25
Substance
ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength
80; 10 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Quality Choice Anti-Itch Clear
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e3c0c46d-3d85-411d-a543-009064cdd19eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
63868-097-06Quality Choice Anti-Itch Clear177 mL in 1 BOTTLE, PLASTICLOTION1776

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-097-06ML - Milliliter63868-09780bb38a0-d99a-4ccd-bc54-01da5a09bd2612022-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5QUALITY CHOICE ANTI-ITCH CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKET ASSOCIATION]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZQUALITY CHOICE ANTI-ITCH CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKET ASSOCIATION]1
PRAMOXINEACTIVE MOIETY068X84E056QUALITY CHOICE ANTI-ITCH CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKET ASSOCIATION]1
ZINC CATIONACTIVE MOIETY13S1S8SF37QUALITY CHOICE ANTI-ITCH CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKET ASSOCIATION]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MQUALITY CHOICE ANTI-ITCH CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKET ASSOCIATION]1
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941QUALITY CHOICE ANTI-ITCH CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKET ASSOCIATION]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4QUALITY CHOICE ANTI-ITCH CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKET ASSOCIATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXQUALITY CHOICE ANTI-ITCH CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKET ASSOCIATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TQUALITY CHOICE ANTI-ITCH CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKET ASSOCIATION]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HQUALITY CHOICE ANTI-ITCH CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKET ASSOCIATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3QUALITY CHOICE ANTI-ITCH CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKET ASSOCIATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHQUALITY CHOICE ANTI-ITCH CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKET ASSOCIATION]1
WATERINACTIVE INGREDIENT059QF0KO0RQUALITY CHOICE ANTI-ITCH CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKET ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-097QUALITY CHOICE ANTI-ITCH CLEAR (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKET ASSOCIATION]6Current NDC, Legacy NDC, 1 package rows20231229_e3c0c46d-3d85-411d-a543-009064cdd19e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fresh Scent PROTECTIVE BABYZINC OXIDECVS Pharmacy, Inc.3f33c62c-43ec-4576-a24d-bd5de07e74d22026-07-23WarningsExact identifier
application number: M016
DERMFREE Vein Target Microneedle PatchALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57449e29-ec46-9c30-e063-6394a90a7b4a2026-07-23WarningsExact identifier
application number: M016
Baby Vitamin A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a125ea-6f9f-310c-e063-6394a90acef22026-07-22WarningsExact identifier
application number: M016
First Aid A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a319d0-d39a-5ff0-e063-6394a90a671d2026-07-22WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
application number: M016
DermasporinLANOLINMarie's Original Formulas LLC562f40aa-eeec-2b7c-e063-6294a90ad68d2026-07-22WarningsExact identifier
application number: M016
CAREALL Vitamin A and DPETROLATUMNew World Imports, Incef89a68a-74c1-4c42-8078-b7a208ace0de2026-07-22WarningsExact identifier
application number: M016
DermactLANOLINMarie's Original Formulas LLC57121dbe-e886-a562-e063-6294a90a367f2026-07-22WarningsExact identifier
application number: M016
Universal WITCH HAZELWITCH HAZELUniversal Distribution Center LLC7e0b56ef-fa41-4862-b387-5b58d81d67d42026-07-22WarningsExact identifier
application number: M016
Aveeno Soothing Bath TreatmentOATMEALKenvue Brands LLC0c410b8e-025f-477c-afac-6e2e9ac88f7d2026-07-21WarningsExact identifier
application number: M016
DERMFREE SCAR SHEETSSILICONE GEL 1% SCAR SHEETSJiangxi Yudexi Pharmaceutical Co., LTD4a4ce316-4b92-7e81-e063-6294a90af6db2026-07-21WarningsExact identifier
application number: M016
DERMFREE VARICOSE VEINSDIMETHICONE 3% VARICOSE VEINSJiangxi Yudexi Pharmaceutical Co., LTD4a5a2d1d-9e84-18eb-e063-6394a90a97ee2026-07-21WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
application number: M016
Mederma Stretch Marks TherapyDIMETHICONEPMI Branded Pharmaceuticals, Inc.0f2918e3-9615-40e3-ab7e-6bfbe022e03c2026-07-16WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
application number: M016
DoveMEN CARE ANTIBACTERIAL CARE MOISTURIZING CREAM BARConopco d/b/a Unilever56bd6fcb-c762-4e5a-e063-6394a90a34382026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINPMI Branded Pharmaceuticals, Inc.25bc1eae-3502-4c63-bd8a-43be2dfb0d6d2026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINL. Perrigo Company9c3d9e08-9428-4b28-82a2-0cb24c3c92a32026-07-16WarningsExact identifier
application number: M016
aftershaveCERAMIDE NPShengnan (Guangzhou) Cosmetics Co., LTD56a17ac9-803b-932c-e063-6394a90aae902026-07-15WarningsExact identifier
application number: M016
Clear Root Labs Wound CareCRL WOUND CARE OINTMENTAidance Scientific Inc. DBA Aidance Skincare & Topicals56a6dbc7-5001-c095-e063-6294a90a1aa02026-07-15WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-097-0663868009706177 mL in 1 BOTTLE, PLASTIC (63868-097-06) 177 ml2017-12-120000-00-00NoNoCurrent