FDA.reportPublic FDA data

NDC 49520-904 - CALM IT DOWN KIT

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49520-904
Manufacturer
mybody
Effective date
2014-06-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CALM IT DOWN KIT - mybodymybody2014-06-30HUMAN OTC DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
CALCIUM BEHENATEINACTIVE INGREDIENTJ5VFA9V6YGCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C5CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
DIMETHICONOL (41 MPA.S)INACTIVE INGREDIENT343C7U75XWCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
LYCOPENEINACTIVE INGREDIENTSB0N2N0WV6CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
MELANIN SYNTHETIC (TYROSINE, PEROXIDE)INACTIVE INGREDIENTO0CV1RMR44CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
METHICONE (20 CST)INACTIVE INGREDIENT6777U11MKTCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERINACTIVE INGREDIENTEG97988M5QCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM0CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
SORBITAN ISOSTEARATEINACTIVE INGREDIENT01S2G2C1E4CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
SUCROSE PALMITATEINACTIVE INGREDIENT3OSQ643ZK5CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1

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 139 of 271 · 5,410 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycerinGLYCERINChain Drug Consortium LLC022dd494-cb3c-4fa7-be99-4c38fabdc6122025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINDSC Laboratories Inc.5e97c4d2-e41d-5bb6-e053-2a91aa0a31632025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINCVS Pharmacy94e4a6f3-43d0-b2a5-e053-2a95a90aa1152025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINChain Drug Marketing Association Inc.5e83d3ef-91c5-1c3a-e053-2a91aa0a93ed2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINRite Aid Corporation5da2ea79-f3bc-b82b-e053-2a91aa0af0af2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINRite Aid Corporation5da2ea79-f37a-b82b-e053-2a91aa0af0af2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINDSC Laboratories Inc.a381838b-d1ae-11c5-e053-2a95a90a7bcb2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacy90a4d385-d548-420b-91d2-54d5e819fcce2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
Calmol 4ZINC OXIDE AND COCOA BUTTERResical Inc.5516f800-d3fa-4b90-a3eb-c0bdf3183b9b2025-10-24WarningsExact identifier
unii: SOI2LOH54Z
GlycerinGLYCERINCVS Pharmacy3a59c4a9-5f86-406a-e054-00144ff8d46c2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINCardinal Health7e7e9366-af1e-e0ff-e053-2a91aa0a94872025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINCardinal Healthc2b02afc-5a8a-2a25-e053-2a95a90ae45c2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
Signature Care Hemorrhoidal Cream (with applicator)PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUMBETTER LIVING BRANDS, LLCb026a386-5e38-52ed-e053-2a95a90a6b0e2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
Maximum Strength Moisture BarrierPETROLATUM AND ZINC OXIDEDerma Sciences Canada Inc.41ee91c0-d196-cc0f-e063-6394a90a7b972025-10-24WarningsExact identifier
unii: SOI2LOH54Z
Lemon Glycerine SwabsticksGLYCERINEPHOENIX HEALTHCARE SOLUTIONS, LLC436919f7-14cd-4318-9388-b3e1cbec176b2025-10-23WarningsExact identifier
unii: PDC6A3C0OX
PERRICONE MD VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30TITANIUM DIOXIDETHG Beauty USA LLC397b4338-fec8-5228-e063-6394a90ad97d2025-10-23WarningsExact identifier
unii: 15FIX9V2JP
Perricone MD HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer Broad Spectrum SPF 30TITANIUM DIOXIDETHG Beauty USA LLC38c80373-1d5a-c7f4-e063-6294a90aa9c22025-10-23WarningsExact identifier
unii: 15FIX9V2JP
Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35ZINC OXIDE, TITANIUM DIOXIDETHG Beauty USA LLC254b4692-a459-6119-e063-6394a90a0a602025-10-23WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Calendula Essential Hydrating Broad Spectrum SPF 30 SunscreenZINC OXIDENaturopathica Holistic Health41d75815-e281-bf88-e063-6294a90afeff2025-10-23WarningsExact identifier
unii: SOI2LOH54Z
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.