FDA.reportPublic FDA data

Clear Anti Itch

Product NDC
36800-218
11-digit product format
368000218
Labeler code
36800
Product ID
36800-218_4ab81c23-56ef-2b5b-e063-6294a90abe9c
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine HCl, Zinc acetate
Dosage form
LOTION
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-03
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
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
36800-218-30Clear Anti Itch177 mL in 1 BOTTLE, PLASTICLOTION17721

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-218-30ML - Milliliter36800-218b6707b3a-e7a0-4720-a0ac-71dc1b8a7e1412024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07ACLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
PRAMOXINEACTIVE MOIETY068X84E056CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
ZINC CATIONACTIVE MOIETY13S1S8SF37CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
POLYSORBATE 40INACTIVE INGREDIENTSTI11B5A2XCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM393CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1
WATERINACTIVE INGREDIENT059QF0KO0RCLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-218CLEAR ANTI ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [TOPCO ASSOCIATES]19Current NDC, Legacy NDC, 1 package rows20240731_8d3d1ff5-4868-495d-807c-e45aa2176f63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSN8d3d1ff5-4868-495d-807c-e45aa2176f6321
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCD8d3d1ff5-4868-495d-807c-e45aa2176f6321
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSY8d3d1ff5-4868-495d-807c-e45aa2176f6321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-218-3036800021830177 mL in 1 BOTTLE, PLASTIC (36800-218-30) 177 ml2009-06-030000-00-00NoNoCurrent