FDA.reportPublic FDA data

Clear Anti-Itch

Product NDC
83324-245
11-digit product format
833240245
Labeler code
83324
Product ID
83324-245_4bcf5319-eec6-6925-e063-6394a90a29f0
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine HCl, Zinc acetate
Dosage form
LOTION
Route
TOPICAL
Labeler
Chain Drug Marketing Association
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-26
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
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
Clear Anti-Itch
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup
FM5526K07AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234546Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ff6bd85-3658-47ea-b6ca-0eb5d8dbb693Available on FDA.report

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
83324-245-06Clear Anti-Itch177 mL in 1 BOTTLE, PLASTICLOTION1773

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-245-06ML - Milliliter83324-245f73ce693-76c0-48bd-9b07-8b850f3ca79212025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-245CLEAR ANTI-ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [CDMA]2Current NDC, 1 package rows20250228_1ff6bd85-3658-47ea-b6ca-0eb5d8dbb693.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 8 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USA8cbe9b1f-fec0-9579-e053-2995a90ac4612026-06-22WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMWalmart Inc.e294a871-ae73-4a4f-89a3-9ebf0b4fd03a2026-06-19Warnings, Adverse reactionsExact identifier
application number: M016
Diaper Rash CreamZINC OXIDEFoshan Desha Biotechnology Co., Ltd.5487ad62-3d73-042e-e063-6394a90afe8c2026-06-18WarningsExact identifier
application number: M016
Baby HealingOintmentPETROLATUMFoshan Desha Biotechnology Co., Ltd.5488b81a-e5fe-1452-e063-6394a90a2ae42026-06-18WarningsExact identifier
application number: M016
Baby Eczema Moisturizing CreamCOLLOIDAL OATMEALFoshan Desha Biotechnology Co., Ltd.548a0c34-6aac-14f7-e063-6394a90ae6522026-06-18WarningsExact identifier
application number: M016
Jell with Vitamin A DLANOLIN, PETROLATUMJell Pharmaceuticals Pvt Ltd.d976e5f0-1be5-d9c4-e053-2a95a90a44a42026-06-17WarningsExact identifier
application number: M016
DoveANTIBACTERIAL CARE BEAUTY BARConopco d/b/a Unilever547472cf-4902-584e-e063-6294a90a28ac2026-06-17WarningsExact identifier
application number: M016
Dr Sosnowskis Chafing Hero Severe Chafing BalmLANOLINHerstat (USA) Inc.389041a8-7316-b38e-e063-6294a90a3e8e2026-06-17WarningsExact identifier
application number: M016
Drs. Pharmacy Creamy Cocoa Butter Petroleum JellyWHITE PETROLATUMOL PHARMA TECH, LLC Drs PHARMACY546749e3-70c5-10e8-e063-6294a90ad8c42026-06-16WarningsExact identifier
application number: M016
Drs. Pharmacy Creamy Petroleum JellyWHITE PETROLATUMOL PHARMA TECH, LLC Drs PHARMACY54698388-f9e8-c470-e063-6394a90a783b2026-06-16WarningsExact identifier
application number: M016
MedlineZINC OXIDEMedline Industries, LP3c319953-04fc-87a8-e063-6294a90a50582026-06-15WarningsExact identifier
application number: M016
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
application number: M016
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
application number: M016
HEALMUSZ HEALTHY FEETUREA 40% SALICYLIC ACID 2% GREEN TEA LEAFL 1% COCONUT OIL 1% HEALTHY FEETJiangxi Yudexi Pharmaceutical Co., LTD4a34b6de-03ec-3be4-e063-6294a90afb522026-06-14WarningsExact identifier
application number: M016
PUVIDA SNOW BLEACHNIACINAMIDE 15% SNOW BLEACHJiangxi Yudexi Pharmaceutical Co., LTD4a48ebbd-7c80-1bce-e063-6294a90ab4ae2026-06-14WarningsExact identifier
application number: M016
XIMONTH Foot Shoe DeodorizerGLYCERINShantou Ximonth Biotechnology Co., Ltd.541d9ce9-62ad-847e-e063-6394a90a55e02026-06-13WarningsExact identifier
application number: M016
Skin Protectant with 33% Petrolatum Advance Moisturizing CreamPETROLATUMAldermed Inc.87413149-d39f-4f8a-b1c9-6de5eb37ff7e2026-06-12WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDE, WHITE PETROLATUMAldermed Inc.54154a72-27ad-7bfa-e063-6394a90a4eca2026-06-12WarningsExact identifier
application number: M016
Circletong Tag Wart Remover PatchesGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.541b0fe9-f900-8191-e063-6394a90af3212026-06-12WarningsExact identifier
application number: M016
Baby ButzZINC OXIDEOlen Skin Care Corporatione6be6b62-13a4-410d-b8ac-457b58fd23da2026-06-10WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSN1ff6bd85-3658-47ea-b6ca-0eb5d8dbb6933
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCD1ff6bd85-3658-47ea-b6ca-0eb5d8dbb6933
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSY1ff6bd85-3658-47ea-b6ca-0eb5d8dbb6933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-245-0683324024506177 mL in 1 BOTTLE, PLASTIC (83324-245-06) 177 ml2025-02-26NoNoCurrent