FDA.reportPublic FDA data

Clear Anti-Itch

Product NDC
72476-218
11-digit product format
724760218
Labeler code
72476
Product ID
72476-218_4a2b287c-4757-e1a2-e063-6394a90a80e1
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine HCl, Zinc acetate
Dosage form
LOTION
Route
TOPICAL
Labeler
Retail Business Services, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-22
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

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 Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5, FM5526K07A
Rxcui1234546

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
72476-218-30Clear Anti-Itch177 mL in 1 BOTTLE, PLASTICLOTION17717

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-218CLEAR ANTI-ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [RETAIL BUSINESS SERVICES, LLC]15Current NDC, Legacy NDC, 1 package rows20240906_a80b8fee-2dd9-4640-a4f8-4cf940df8563.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSNa80b8fee-2dd9-4640-a4f8-4cf940df856317
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCDa80b8fee-2dd9-4640-a4f8-4cf940df856317
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSYa80b8fee-2dd9-4640-a4f8-4cf940df856317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72476-218-3072476021830177 mL in 1 BOTTLE, PLASTIC (72476-218-30) 177 ml2016-03-220000-00-00NoNoCurrent