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

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
8d3d1ff5-4868-495d-807c-e45aa2176f63Available 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
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

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 1 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Drs. pharmacy Scar CreamALLANTOINOL PHARMA TECH, LLC Drs PHARMACYd0381034-8cf7-5e8d-e053-2995a90a9faa2026-09-09WarningsExact identifier
application number: M016
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
application number: M016
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
application number: M016
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
application number: M016
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact identifier
application number: M016

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