FDA.reportPublic FDA data

NDC 49520-902 - 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
49520-902
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
REVERSE IT KIT - mybodymybody2014-06-30HUMAN OTC DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
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
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933REVERSE IT 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
CALCIUM BEHENATEINACTIVE INGREDIENTJ5VFA9V6YGREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41REVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZREVERSE IT 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
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C5REVERSE IT 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
DIMETHICONOL (41 MPA.S)INACTIVE INGREDIENT343C7U75XWREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675REVERSE IT 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
GLYCERININACTIVE INGREDIENTPDC6A3C0OXREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62REVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
LYCOPENEINACTIVE INGREDIENTSB0N2N0WV6REVERSE IT 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 INGREDIENTO0CV1RMR44REVERSE IT 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
METHICONE (20 CST)INACTIVE INGREDIENT6777U11MKTREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERINACTIVE INGREDIENTEG97988M5QCALM IT DOWN KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMERINACTIVE INGREDIENTEG97988M5QREVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM0REVERSE IT 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
SORBITAN ISOSTEARATEINACTIVE INGREDIENT01S2G2C1E4REVERSE IT KIT (TITANIUM DIOXIDE, ZINC OXIDE) KIT [MYBODY]1
SUCROSE PALMITATEINACTIVE INGREDIENT3OSQ643ZK5REVERSE IT 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
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0REVERSE IT 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 197 of 329 · 6,574 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC31f1e961-3719-f70a-e063-6394a90a481e2025-05-31WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Aluminum Hydroxide, Magnesium Hydroxide, and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEAmerican Health Packaging2faf291e-1d62-412a-a05e-e992cb7def6a2025-05-30WarningsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEATLANTIC BIOLOGICALS CORP376660a2-becb-48cf-a9f5-6a76a8b8ca702025-05-30WarningsExact identifier
unii: 92RU3N3Y1O
BerbereX Wound CleanserBENZETHONIUM CHLORIDECosco International, Inc.08b28f52-21fc-4694-a163-91c8193b40082025-05-30WarningsExact identifier
unii: 344S277G0Z
Code Red Eye Drops MicroGLYCERIN AND NAPHAZOLINE HYDROCHLORIDE4 Trees LLC2a15ea9a-ff67-446b-8b83-6517d25ff38a2025-05-29WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sunny Sailor First Mate Face Stick SPF 30ZINC OXIDESUNNY SAILOR LLC8ef7e0c8-e76b-4e84-ac9d-169f85e5e36e2025-05-28WarningsExact identifier
unii: SOI2LOH54Z
Dr Mercola Broad Spectrum SPF15ZINC OXIDENatural Health Partners, LLC47f6b19e-ede8-0daf-e054-00144ff88e882025-05-28WarningsExact identifier
unii: SOI2LOH54Z
Dr. Mercola Broad SpectrumZINC OXIDENatural Health Partners, LLC47f6ec0a-1144-55dd-e054-00144ff8d46c2025-05-28WarningsExact identifier
unii: SOI2LOH54Z
Dr. Mercola Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDENatural Health Partners, LLC47f6ab9e-fa73-496a-e054-00144ff8d46c2025-05-28WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
TALLOW SUNSCREENNON-NANO ZINC OXIDEFOUNDATION COMMERCE INC363e38bf-b4b4-dcc4-e063-6294a90a5d2f2025-05-28WarningsExact identifier
unii: SOI2LOH54Z
Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30OCTINOXATE, ZINC OXIDESOLVADERM LLC86dbd8c3-e95a-49a8-afe6-ff9d985e28ba2025-05-27WarningsExact identifier
unii: SOI2LOH54Z
Protect Daily Ritual Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35ce8307-387b-2b40-e063-6294a90a28bc2025-05-23Exact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
terrasil Diabetics Ulcer and Sore ReliefALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionsfd6bf169-f1e2-48d4-b98d-8f3c39981a892025-05-23WarningsExact identifier
unii: 344S277G0Z
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEPZINC OXIDEONESKIN INC.35d57d3f-376c-2307-e063-6294a90adf512025-05-23WarningsExact identifier
unii: SOI2LOH54Z
Butalbital, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEST. MARY'S MEDICAL PARK PHARMACY36229f70-aa73-b112-e063-6394a90a5b492025-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3G6A5W338E
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: OJ245FE5EU
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Oathology Inzincable Lip Balm SPF 35ZINC OXIDESKINOATH LLC289a5492-af57-42e5-82af-3f1e4b369d682025-05-22WarningsExact identifier
unii: SOI2LOH54Z
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, LightZINC OXIDEALLI LLC3cb4459b-1776-414a-b5c4-0ffb9f1df7662025-05-22WarningsExact identifier
unii: SOI2LOH54Z
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, DarkZINC OXIDEALLI LLC81633684-f9ac-45cb-8a3e-f0c30b229a822025-05-22WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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