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
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
Humco Calaclear
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234546Internal RxNorm lookup
1248193Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5fca3a73-6d66-496b-bd33-6e044f9039bcAvailable 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
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

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 46 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rico Hand SanitizerALCOHOLHANUL CO.,LTDa6065fcd-3968-d5a1-e053-2a95a90ab8d62025-01-20WarningsExact identifier
application number: M016
VITAMIN A and DWHITE PETROLATUMVIVE HEALTH LLC2bd4465b-6e46-51e2-e063-6294a90a695f2025-01-16WarningsExact identifier
application number: M016
VITAMIN A and DWHITE PETROLATUMVIVE HEALTH LLC2bd4a2b0-f586-3ab1-e063-6294a90aa1ed2025-01-16WarningsExact identifier
application number: M016
Dermoia Manuka Honey EczemaOATMEALTREASUREWISE LLC18c174de-6626-45ee-a6aa-f75a48daab8d2025-01-15WarningsExact identifier
application number: M016
AllantoinMEDICINAL MASSAGE OILCarolina Cannabis Creations L.L.C04b5619b-2122-f159-e063-6394a90a2e052025-01-15WarningsExact identifier
application number: M016
Skin Barista 2in1 White Body PerfectionDIMETHICONEPioom Cosmetic Co.,ltd2d7fc20c-31a7-195b-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M016
Skin Barista Rice Bran Cleansing FoamALLANTOINPioom Cosmetic Co.,ltd2d7fc7f6-1e89-116c-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M016
Hammertech Vitamin A and DWHITE PETROLATUMHAMMER TECH LLCffe96aa1-db6b-33e4-e053-6394a90a7e4e2025-01-14WarningsExact identifier
application number: M016
NOON Cartessa Accelerate ProgramALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltd400ead81-ab07-400f-b261-db330e0fd0042025-01-14WarningsExact identifier
application number: M016
NOON Post Procedure ProgramALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltd9d1d11b4-40ff-4ea8-a3af-655f457c05f12025-01-14WarningsExact identifier
application number: M016
OLP diaper Rash cream A and DZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACYd6faa4d9-751c-a1b6-e053-2a95a90aee5b2025-01-09WarningsExact identifier
application number: M016
ANTI-ITCHZINC ACETATE , DIPHENHYDRAMINEOL PHARMA TECH, LLCb79d3096-c609-e710-e053-2995a90a8da22025-01-09WarningsExact identifier
application number: M016
ANTIBACTERIAL DREAMY FLORALSGLYCERINQuimicas Handal de Centroamerica SA de CV09f73bec-516d-90f0-e063-6394a90aecab2025-01-08WarningsExact identifier
application number: M016
AOAO Repair Foot CreamUREA,SALICYLIC ACID,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALOE VERA LEAF EXTRACT,COCOS NUCIFERA (COCONUT) OIL.Guangdong Junhui Biotechnology Co.,LTD21064e84-c827-ca82-e063-6394a90a6c652025-01-08WarningsExact identifier
application number: M016
A0A0 Rice Ceramide Anti Wrinkle Age Essence Box SetBIFIDA FERMENT LYSATE,ORYZA SATIVA (RICE) EXTRACT,CERAMIDE NP,COLLAGEN,TOCOPHEROL.Guangdong Junhui Biotechnology Co., LTD22736b2d-45a0-49b6-e063-6394a90a7b0b2025-01-08WarningsExact identifier
application number: M016
Body Milk for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,BUTYROSPERMUM PARKII (SHEA) BUTTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,THEOBROMA CACAO (COCOA) SEED BUTTERGuangzhou Senmai Biotechnology Co.1dcd94dc-214d-de72-e063-6294a90a695f2025-01-08WarningsExact identifier
application number: M016
Stretch Marks creamSESAMUM INDICUM (SESAME) SEED EXTRACT,PRUNUS PERSICA (PEACH) RESIN EXTRACT,STERCULIA URENS GUM,TRIPEPTIDE-1,HEXAPEPTIDE-9,ACETYL TETRAPEPTIDE-9,PALMITOYL PENTAPEPTIDE-4,PALMITOYL TETRAPEPTIDE-7,ACETYL HEXAPEPTIDE-8.Guangzhou Senmai Biotechnology Co.1e827483-259a-d12f-e063-6394a90a78852025-01-08WarningsExact identifier
application number: M016
Body oil for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILGuangzhou Senmai Biotechnology Co.1daeb2e8-f18c-06c3-e063-6294a90a63852025-01-08WarningsExact identifier
application number: M016
AOA0 Snail Ginseng CreamSNAIL SECRETION FILTRATE,PANAX GINSENG ROOT EXTRACT,COLLAGEN,TOCOPHEROL,ASCORBIC ACID.Guangdong Junhui Biotechnology Co., LTD22873a99-1032-f4ec-e063-6394a90a64322025-01-08WarningsExact identifier
application number: M016
Massage cream for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL,BUTYROSPERMUM PARKII (SHEA) BUTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,CERAMIDE NP,SOLUBLE COLLAGEN,HYDROLYZED ELASTIN,PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OILGuangzhou Senmai Biotechnology Co.1dce7cf1-1fb8-e14e-e063-6394a90ae34a2025-01-08WarningsExact identifier
application number: M016

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