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 50 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Softlips Peach PassionDIMETHICONEThe Mentholatum Company4a133e73-e51b-4f04-91de-dc8c4d4dba302024-12-17WarningsExact identifier
application number: M016
Sweet Cheeks DiaperZINC OXIDETubby Todd4ed0afe1-c893-453e-b4d5-f32561360ec12024-12-17WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMGeri-Care Pharmaceuticals, Corpf40a29c2-65ea-91f9-e053-2a95a90ac4392024-12-17WarningsExact identifier
application number: M016
Vitamin A and DPETROLATUMGeri-care Pharmaceutials Corpfd76c101-a287-f92c-e053-6294a90a44682024-12-17WarningsExact identifier
application number: M016
Foster and Thrive Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC298171e1-2826-d33b-e063-6394a90a875a2024-12-17WarningsExact identifier
application number: M016
Secura Dimethicone ProtectantDIMETHICONESmith & Nephew Medical Ltd83f92ac9-4114-4192-926d-be2854a841062024-12-16WarningsExact identifier
application number: M016
CVS Maximum Strength Anti-Itch CreamHYDROCORTISONE 1%CVS Healthc2876cba-d7e7-de5c-e053-2a95a90a63552024-12-16WarningsExact identifier
application number: M016
Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip)DIMETHICONE, OCTINOXATE, OCTISALATE, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc4121d671-521c-4f36-b2db-652c13f730c62024-12-16WarningsExact identifier
application number: M016
Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Mint Lip Balm)DIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc24e1d2fc-3f9d-4e86-a397-61bfbfc4d58c2024-12-16WarningsExact identifier
application number: M016
Balmex Diaper RashZINC OXIDE 11.3%Randob Labs, LTDf7f7a89d-d4e0-9faa-e053-6294a90aaf7b2024-12-15WarningsExact identifier
application number: M016
QC ScarALLANTOIN 0.5%CDMAf7e3d751-a47a-2bca-e053-6394a90a65412024-12-15WarningsExact identifier
application number: M016
Dr. Butler Soothing IncontinencePETROLATUM 36%Beyond Health P.A.d17a0c28-a5b7-4df0-e053-2995a90a8edd2024-12-15WarningsExact identifier
application number: M016
Copperlife FootDIMETHICONE 1%Tommie Copper, Inc.cb825d2c-6333-3c1f-e053-2995a90a78f32024-12-15WarningsExact identifier
application number: M016
Tommie Copper FootDIMETHICONE 1%Tommie Copper, Inc.ca3d3374-a3d4-69e5-e053-2995a90a3ece2024-12-15WarningsExact identifier
application number: M016
Evereden Healing Eczema TreatmentCOLLOIDAL OATMEALEden Brands, Inc.d43f0eaa-aab0-eaff-e053-2995a90ac5c82024-12-13WarningsExact identifier
application number: M016
Babo Fragrance Free Diaper CreamZINC OXIDEBabo Botanicals, Inc.adcd4fc7-c400-fc8e-e053-2a95a90a7e1f2024-12-12WarningsExact identifier
application number: M016
DomeboroALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATEAdvantice Health, LLC.28c39200-2f7c-954b-3ce7-7349b27388122024-12-12WarningsExact identifier
application number: M016
Atopis Eczema Therapy CreamCOLLOIDAL OATMEALBionona Limited8d4b4a14-b631-f2fa-e053-2a95a90a932f2024-12-12WarningsExact identifier
application number: M016
Desitin Daily Defense Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLCb6e0d1a3-e469-4102-916b-d5cc8ca12e732024-12-11WarningsExact identifier
application number: M016
Little Me Multipurpose Baby BalmWHITE PETROLATUMShalom International Corpe09518f1-3691-4d85-a8e1-a5c4520570662024-12-11WarningsExact 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