FDA.reportPublic FDA data

Humco Calagesic

Product NDC
0395-0420
11-digit product format
003950420
Labeler code
0395
Product ID
0395-0420_101d12b5-fd3a-678d-e063-6294a90a64ea
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine and Pramoxine Hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Humco Holding Group, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-03-25
Substance
ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength
80; 10 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

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 Calagesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE80 mg/mL
PRAMOXINE HYDROCHLORIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1234532Internal RxNorm lookup
1234539Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8c43590d-56ec-4588-8076-99ba94a16685Available 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
0395-0420-96Humco Calagesic177 mL in 1 BOTTLE, PLASTICLOTION1776

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-0420-96ML - Milliliter0395-0420a7f0cab7-7116-4ac3-839a-58de08c1072f12014-04-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-0420HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.]5Current NDC, Legacy NDC, 1 package rows20231216_8c43590d-56ec-4588-8076-99ba94a16685.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 10 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EELHOE Cuticle Pusher PenGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.52c7f956-a2a1-ae1d-e063-6294a90ab3c22026-05-27WarningsExact identifier
application number: M016
Dermoia Eczema Relief Colloidal OatmealOATMEALTreasurewise LLC1285c0a4-5fdf-4691-a8c6-1de8e2e2f66a2026-05-27WarningsExact identifier
application number: M016
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWal-Mart Stores, Inc.61e76e2a-fc46-7a64-e053-2991aa0a56a82026-05-26WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEWal-Mart Stores, Inc.61929c97-bd6b-0d7c-e053-2991aa0aa5712026-05-26WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
application number: M016
Humco CalamineCALAMINE 8% AND ZINC OXIDE 8%Humco holding Group, Inc.f7dcd959-fb98-43bb-8dd3-a662bf8a053c2026-05-26WarningsExact identifier
application number: M016
Advanced HealingPETROLATUMCVS Pharamacy, Inc0bd3380e-2284-44a7-b2ef-68c9909627fd2026-05-26Warnings, Adverse reactionsExact identifier
application number: M016
CeraVe Developed with Dermatologists Healing Lip BalmPETROLATUML'Oreal USA Products Inc21dc8842-0672-4d46-bcea-b8e3d54c48bf2026-05-20WarningsExact identifier
application number: M016
AFTER CAREDIMETHICONEMerz North Americac19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae2026-05-20WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USA63b551fc-7d16-c099-e053-2a91aa0a5f2c2026-05-18WarningsExact identifier
application number: M016
ADVANCED SILICONE SCARALLANTOINYantai Aien Biotechnology Co., Ltd.51ffdc45-5acf-ae20-e063-6294a90a55e82026-05-17WarningsExact identifier
application number: M016
LCFateLC Nail LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.51ea23f4-0a23-4ae1-e063-6394a90aa0512026-05-16WarningsExact identifier
application number: M016
Radlive Active Defense Nano-Silver CreamCOLLOIDAL OATMEALSilverCeuticals51e23135-008d-9db5-e063-6294a90a7d612026-05-15WarningsExact identifier
application number: M016
Cerave Developed with Dermatologists HealingPETROLATUMLOreal USA Products Incde44ac01-ba17-4f97-ac12-9ea348013bde2026-05-14WarningsExact identifier
application number: M016
Triple 3x Max Diaper RashZINC OXIDEAdvantice Health, LLCe554046b-cd0a-4a6e-8f24-2e610c6974322026-05-14WarningsExact identifier
application number: M016
Eczema TherapyCOLLOIDAL OATMEALSilverCeuticals3a26a35e-a098-0e22-e063-6294a90a96b92026-05-13WarningsExact identifier
application number: M016
Nail- PflasterGLYCERINShantou Ximonth Biotechnology Co., Ltd.519681bc-6312-f627-e063-6394a90a28452026-05-11WarningsExact identifier
application number: M016
HydratingPETROLATUMAldermed Inc.4aa6a354-e487-4b65-e063-6394a90abbf02026-05-09WarningsExact identifier
application number: M016
Diaper RashZINC OXIDEAldermed Inc.4aa79292-dc91-b538-e063-6294a90ac3f02026-05-09WarningsExact identifier
application number: M016
XIMONTH Nail Fungus Care LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.514a998d-aa2a-46b6-e063-6294a90a6c222026-05-08WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234539CALAGESIC 8 % / 1 % Topical LotionPSN8c43590d-56ec-4588-8076-99ba94a166856
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSN8c43590d-56ec-4588-8076-99ba94a166856
1234539calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion [Calagesic]SBD8c43590d-56ec-4588-8076-99ba94a166856
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD8c43590d-56ec-4588-8076-99ba94a166856
1234539Calagesic (calamine 8 % / pramoxine hydrochloride 1 % ) Topical LotionSY8c43590d-56ec-4588-8076-99ba94a166856
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY8c43590d-56ec-4588-8076-99ba94a166856

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-0420-9600395042096177 mL in 1 BOTTLE, PLASTIC (0395-0420-96) 177 ml2017-11-130000-00-00NoNoCurrent