FDA.reportPublic FDA data

Health Care Calamine

Product NDC
64092-413
11-digit product format
640920413
Labeler code
64092
Product ID
64092-413_0cf4d771-f6b1-ec8c-e063-6394a90a3551
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine 8% and Zinc Oxide 8%
Dosage form
LOTION
Route
TOPICAL
Labeler
Great Lakes Wholesale, Marketing and Sales Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
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
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
Health Care Calamine
Listing expiration
2026-12-31

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
5d8f02fb-0794-8ec2-e053-2991aa0aac63Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64092-413-96Health Care Calamine177 mL in 1 BOTTLE, PLASTICLOTION1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64092-413HEALTH CARE CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [GREAT LAKES WHOLESALE, MARKETING AND SALES INC]5Current NDC, Legacy NDC, 1 package rows20231221_5d8f02fb-0794-8ec2-e053-2991aa0aac63.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 54 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Find Your Happy PlaceWRAPPED IN YOUR ARMS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0ef938-da18-3b9c-e053-2995a90acb722024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceSUNKISSED OCEAN WAVES HAND SANITIZERConopco Inc. d/b/a/ Unileverba0db6a3-222a-093f-e053-2a95a90ac88a2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceLAZY WEEKENDS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0f4571-e752-d925-e053-2995a90afd3a2024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED GREEN CLAY AND EUCALYPTUS HAND SANITIZERConopco Inc. d/b/a/ Unileverba48b351-0d7f-5a41-e053-2a95a90a348c2024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED COCONUT AND WARM VANILLA HAND SANITIZERConopco Inc. d/b/a/ Unileverba0ffbf9-7dd0-f685-e053-2995a90a0be02024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED PATCHOULI AND ORANGE FLOWER HAND SANITIZERConopco Inc. d/b/a/ Unileverba49e27b-1ade-a75a-e053-2a95a90a18432024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED CHERRY BLOSSOM AND TEA ROSE HAND SANITIZERConopco Inc. d/b/a/ Unileverba4979a3-ae30-42e4-e053-2995a90abfe72024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceSWEET TREATS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0fa3cb-8c25-7511-e053-2995a90a42872024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED LAVENDER AND HYSSOP HAND SANITIZERConopco Inc. d/b/a/ Unileverba484531-ef7b-17ed-e053-2995a90a50b32024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED GRAPEFRUIT AND RED GINGER HAND SANITIZERConopco Inc. d/b/a/ Unileverba4a573d-def4-a735-e053-2995a90a4f292024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER LAVENDERConopco Inc. d/b/a/ Unileverddcb0871-9903-125f-e053-2a95a90a75de2024-11-07WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN5d8f02fb-0794-8ec2-e053-2991aa0aac635
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD5d8f02fb-0794-8ec2-e053-2991aa0aac635
617954calamine 8 % / zinc oxide 8 % Topical LotionSY5d8f02fb-0794-8ec2-e053-2991aa0aac635
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY5d8f02fb-0794-8ec2-e053-2991aa0aac635

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64092-413-9664092041396177 mL in 1 BOTTLE, PLASTIC (64092-413-96) 177 ml2017-10-270000-00-00NoNoCurrent