Clear Anti-Itch

Product NDC
11344-812
11-digit product format
113440812
Labeler code
11344
Product ID
11344-812_5b87a395-fb78-70b0-e063-6394a90a8839
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine HCl, Zinc acetate
Dosage form
LOTION
Route
TOPICAL
Labeler
Nice-Pak Products, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-29
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

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
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
11344-812-30Clear Anti-Itch177 mL in 1 BOTTLE, PLASTICLOTION1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-812CLEAR ANTI-ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [CONSUMER PRODUCT PARTNERS, LLC]1Current NDC, 1 package rows20240730_b5b810b8-97c0-4ed5-bd30-17dc01e08d61.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 18 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Skin Mercy Recovery CreamCOLLOIDAL OATMEALCultskin Apothecary, Inc.4bac19f3-13bb-8d18-e063-6394a90aa3932026-02-25WarningsExact identifier
application number: M016
Skin Mercy Intense Recovery CreamCOLLOIDAL OATMEALCultskin Apothecary, Inc.468f21c6-2d6f-1654-e063-6394a90ab2f52026-02-25WarningsExact identifier
application number: M016
Magnet Eye Sheet MaskEYE MASKGuangdong Bisutang Biotechnology Co., LTD4a0a84d4-4024-5ea7-e063-6394a90a2b6c2026-02-24WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMFamily Dollar Stores, Incac7da793-8a39-4b47-b075-a4c4820cadad2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDFamily Dollar Stores, Inc1a03331e-3676-451c-be22-9a547e8ae6e22026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMFamily Dollar Stores, Inc7e64a424-afdb-4eb9-b6af-7b8123f1e2072026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMH E Be6154e44-d7b2-429c-9bc7-5c064220d3fb2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEH E Bf0b31d52-2903-487a-aa70-0dbdf4c4d7e72026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMH E Bff79e42c-da3f-4aec-acf4-cc26e10a1d082026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONEH E Ba8ad595a-c811-4534-82e0-9a01085b4b1e2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALH E Bce9ffcc1-a4c3-4771-ae27-ba99c74bb1ba2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMH E B460802cc-c1b9-41cb-afe3-ca4078175efb2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMH E B2dd85211-0840-4d0d-8ba7-ea6184a509422026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMMeijer, Inc.12867b23-b203-4bd7-af6d-efddeead26be2026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALMeijer, Inc.c7a4b7f2-4de9-470c-9f5b-0142bd9351372026-02-24Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMBetter Living Brands, LLC75cb8f17-6ef2-403e-ab6e-d8e1e8168ec82026-02-23Warnings, Adverse reactionsExact identifier
application number: M016
WHITE PETROLATUMPETROLATUMSion Biotext Medical Ltd53ca3aeb-1d5d-4964-adb5-1cfa901642da2026-02-23WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEBetter Living Brands, LLC1d491635-9605-44fa-9860-ea23e4e8b21c2026-02-23Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMBetter Living Brands, LLCba50f2b2-aff8-42cd-8af0-369060a901fb2026-02-23Warnings, Adverse reactionsExact identifier
application number: M016
OatmealDIMETHICONEBetter Living Brands, LLCd28c5a60-0597-424f-bf7f-08dca39b22f52026-02-23Warnings, Adverse reactionsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSNb5b810b8-97c0-4ed5-bd30-17dc01e08d613
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCDb5b810b8-97c0-4ed5-bd30-17dc01e08d613
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSYb5b810b8-97c0-4ed5-bd30-17dc01e08d613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-812-3011344081230177 mL in 1 BOTTLE, PLASTIC (11344-812-30) 177 ml2024-07-29NoNoCurrent