FDA.reportPublic FDA data

Humco Calamine

Product NDC
0395-0413
11-digit product format
003950413
Labeler code
0395
Product ID
0395-0413_52b9f60d-7ae7-26c8-e063-6294a90acc20
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine 8% and Zinc Oxide 8%
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
Active strength
160 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 Calamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE160 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
617954Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7dcd959-fb98-43bb-8dd3-a662bf8a053cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-0413-96Humco Calamine177 mL in 1 BOTTLE, PLASTICLOTION1778

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-0413-96ML - Milliliter0395-04137388d9e7-558f-47b8-9386-b0372be86ab312014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZHUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.]1
CALCIUM HYDROXIDEINACTIVE INGREDIENTPF5DZW74VNHUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-0413HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.]7Current NDC, Legacy NDC, 1 package rows20231216_f7dcd959-fb98-43bb-8dd3-a662bf8a053c.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 53 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Advanced Scar GelADVANCED SCAR GELCVS Health2fead2d8-b645-4d45-8e5b-b4f1da4e5a252024-11-12WarningsExact identifier
application number: M016
CVS Health Advanced Scar GelADVANCED SCAR GELCVS Healthc6926594-ad4e-4937-bda2-9311219a88812024-11-12WarningsExact identifier
application number: M016
CVS Zinc OxideZINC OXIDECVS Healthd67533b1-ae3f-4c9a-a6c9-a742290c90e92024-11-11WarningsExact identifier
application number: M016
CVS Eczema Relief Skin ProtectantOATMEALCVS Health3cf25c43-592f-41cb-aa0b-a82f4e7faf3d2024-11-11WarningsExact identifier
application number: M016
DGH Advanced Formula Scar Skin ProtectantALLANTOINDolgencorp Inc950dcffd-d2c3-4ca7-8a15-7cb1016ca3642024-11-08WarningsExact identifier
application number: M016
ABC Arbonne Baby Care Diaper RashDIMETHICONE AND ZINC OXIDEArbonne International, LLCdd1d8198-bb9d-4508-a971-ae3bc624cdd12024-11-08WarningsExact identifier
application number: M016
SUPER SENSITIVE DIAPER RASHZINC OXIDEORGANIC & SUSTAINABLE BEAUTYb0de2a9b-7854-4caf-b7ff-632c1d4a382e2024-11-08WarningsExact identifier
application number: M016
DoveDERMASERIES ECZEMA RELIEF SOOTHING BODY LOTIONConopco, Inc. d/b/a/ Unileverbcfb12ea-304e-7d8c-e053-2a95a90af6062024-11-07WarningsExact identifier
application number: M016
VaselineCLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAMConopco, Inc. d/b/a/ Unileverbd206830-e334-3764-e053-2995a90a74ca2024-11-07WarningsExact identifier
application number: M016
DoveMEN SKIN DEFENSE ANTIBACTERIAL 3N1 HAND BODY SHAVE BARConopco Inc. d/b/a/ Unileverb9e61a03-e000-50ab-e053-2a95a90a32102024-11-07WarningsExact identifier
application number: M016
DoveDOVE CARE AND PROTECT ANTIBACTERIAL NOURISHING FOAMING HAND WASHConopco Inc. d/b/a/ Unileverb9f8cb31-560c-79e0-e053-2a95a90a39ae2024-11-07WarningsExact identifier
application number: M016
DoveCARE AND PROTECT ANTIBACTERIAL HAND WASHConopco Inc. d/b/a/ Unilevered234413-777a-9c82-e053-2a95a90a6f982024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceCATCHING THE SUNRISE HAND SANITIZERConopco Inc. d/b/a/ Unileverb9fa6c72-7c56-6fd0-e053-2995a90a67072024-11-07WarningsExact identifier
application number: M016
DoveCARE AND PROTECT ANTIBACTERIAL FOAMING HAND WASHConopco Inc. d/b/a/ Unilevered24b320-27fc-9714-e053-2995a90a79a62024-11-07WarningsExact identifier
application number: M016
SKINSEIETHYL ALCOHOL LIQUIDConopco Inc. d/b/a/ Unilevera603c419-238f-0bae-e053-2a95a90abc2b2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceUNDER THE STARLIT SKY HAND SANITIZERConopco Inc. d/b/a/ Unileverba0dfe52-c550-94fd-e053-2995a90a98002024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceSUMMERTIME SPRINKLERS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0e474c-db62-910f-e053-2995a90a889e2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceGIRLS NIGHT OUT HAND SANITIZERConopco Inc. d/b/a/ Unileverba0ce03e-5e7b-b09a-e053-2995a90a4eef2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceAFTER THE RAIN HAND SANITIZERConopco Inc. d/b/a/ Unileverba0d27fb-f72f-5e87-e053-2a95a90af7e02024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED CATCUS FLOWER AND BASIL HAND SANITIZERConopco Inc. d/b/a/ Unileverba47599c-3e11-cec3-e053-2a95a90aef7b2024-11-07WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSNf7dcd959-fb98-43bb-8dd3-a662bf8a053c8
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCDf7dcd959-fb98-43bb-8dd3-a662bf8a053c8
617954calamine 8 % / zinc oxide 8 % Topical LotionSYf7dcd959-fb98-43bb-8dd3-a662bf8a053c8
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSYf7dcd959-fb98-43bb-8dd3-a662bf8a053c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-0413-9600395041396177 mL in 1 BOTTLE, PLASTIC (0395-0413-96) 177 ml2017-11-130000-00-00NoNoCurrent