FDA.reportPublic FDA data

Humco Calaclear

Product NDC
0395-0400
11-digit product format
003950400
Labeler code
0395
Product ID
0395-0400_0c929258-b193-bc2f-e063-6394a90a8e47
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine Hydrochloride and Zinc Acetate
Dosage form
LOTION
Route
TOPICAL
Labeler
Humco Holding Group, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-03-25
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Humco Calaclear
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5, FM5526K07A
Rxcui1234546, 1248193

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
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
0395-0400-96Humco Calaclear177 mL in 1 BOTTLE, PLASTICLOTION1777

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-0400-96ML - Milliliter0395-04005d47f9f0-f8d2-4b5e-a5bf-5e5ef8a7de7112014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZHUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]1
PRAMOXINEACTIVE MOIETY068X84E056HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MHUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]1
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-0400HUMCO CALACLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [HUMCO HOLDING GROUP, INC.]7Current NDC, Legacy NDC, 1 package rows20231216_5fca3a73-6d66-496b-bd33-6e044f9039bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248193CALACLEAR 1 % / 0.1 % Topical LotionPSN5fca3a73-6d66-496b-bd33-6e044f9039bc7
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionPSN5fca3a73-6d66-496b-bd33-6e044f9039bc7
1248193pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion [Calaclear]SBD5fca3a73-6d66-496b-bd33-6e044f9039bc7
1234546pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical LotionSCD5fca3a73-6d66-496b-bd33-6e044f9039bc7
1248193Calaclear (pramoxine hydrochloride 1 % / zinc acetate 0.1 % ) Topical LotionSY5fca3a73-6d66-496b-bd33-6e044f9039bc7
1234546pramoxine HCl 1 % / zinc acetate 0.1 % Topical LotionSY5fca3a73-6d66-496b-bd33-6e044f9039bc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-0400-9600395040096177 mL in 1 BOTTLE, PLASTIC (0395-0400-96) 177 ml1998-03-250000-00-00NoNoCurrent