FDA.reportPublic FDA data

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 9 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPRADERMWHITE PETROLATUM, LANOLINOlen Skin Care Corporation4e7199bd-52c6-48e9-9c78-c84e45412faf2026-06-10WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP509ee758-9d53-220c-e063-6394a90a4bd52026-06-09WarningsExact identifier
application number: M016
BABY BUM DIAPERZINC OXIDECreative Consumer Products, Inc. DBA (Doing Business As) Dionis Goat Milk Skincare53d8a654-aaec-6f91-e063-6394a90a73512026-06-09WarningsExact identifier
application number: M016
CELISTAR MICRONEEDLING INFUSIONHYALURONATE SODIUMGuangdong Outeli Biotechnology Co., Ltd.53de46a7-3947-70a7-e063-6294a90ab8292026-06-09WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP3c448cf7-8ca5-c7f7-e063-6294a90a75ff2026-06-08WarningsExact identifier
application number: M016
WOODSLEEP Wild Yam CreamGLYCERINShantou Woodsleep Biotechnology Co., Ltd.53b992fd-5759-57bb-e063-6394a90a16002026-06-08WarningsExact identifier
application number: M016
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
application number: M016
GNP Calamine Topical SuspensionCALAMINE 8% AND ZINC OXIDE 8%Amerisource Bergen777b0e66-1bce-4483-9dad-c46796fd6f232026-06-04WarningsExact identifier
application number: M016
GNP CaldyphenCALAMINE AND PRAMOXINE HYDROCHLORIDEAmerisource Bergen515c58d7-0dc4-45e7-9155-e5270a16290e2026-06-04WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company535a0e8e-6bb4-6652-e063-6394a90aa7ff2026-06-03WarningsExact identifier
application number: M016
Quad WashDIMETHICONEDynarex Corporation535dc862-6a18-26c9-e063-6294a90a3d4a2026-06-03WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.535e42a1-8b14-324d-e063-6394a90a3f652026-06-03WarningsExact identifier
application number: M016
Petroleum Jelly Skin ProtectantWHITE PETROLATUMAcme United Corporation535e94bb-21e8-90be-e063-6394a90a37bb2026-06-03WarningsExact identifier
application number: M016
ADVANCED HEALINGPETROLATUMRejoice International Corp.532c7e5a-4d05-3bd0-e063-6294a90aee002026-06-01WarningsExact identifier
application number: M016
PUTRIZEN 40 UREAGLYCERINShantou Ximonth Biotechnology Co., Ltd.533dadbc-6f20-d880-e063-6394a90a753f2026-06-01WarningsExact identifier
application number: M016
ADVANCED HEALING BALMPETROLATUMRejoice International Corp.53285d82-3755-ca78-e063-6394a90a50192026-05-31WarningsExact identifier
application number: M016
KIEHLS SINCE 1851 Ultra Facial Meltdown RecoveryCOLLOIDAL OATMEALLOreal USA Products Inc22e088b9-b3b1-4c34-be12-a5a31200ec252026-05-29WarningsExact identifier
application number: M016
Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.53008b89-89ab-7650-e063-6294a90ac16c2026-05-29WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED52efd466-49bd-bbdf-e063-6394a90aa1082026-05-28WarningsExact identifier
application number: M016
TheraCare Vitamin A and D plus EPETROLATUMVeridian Healthcare52e0e248-6c04-feb9-e063-6394a90add462026-05-28WarningsExact 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