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 36 of 334 · 6,677 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Iris and Romeo Weekend Skin Cool GlowZINC OXIDEIris and Romeo514f7d70-7b8b-0992-e063-6394a90a1e982026-05-08WarningsExact identifier
unii: SOI2LOH54Z
Kesin MAG-AL PlusALUMINUM AND MAGNESIUM HYDROXIDE W/SIMETHICONE SUSPENSIONKesin Pharma Corporation436b622a-f028-df98-e063-6394a90a3eaa2026-05-08WarningsExact identifier
unii: 92RU3N3Y1O
Kesin MAG-AL Plus XSALUMINUM AND MAGNESIUM HYDROXIDE W/SIMETHICONE SUSPENSIONKesin Pharma Corporation436b89f7-e417-0df2-e063-6394a90a96df2026-05-08WarningsExact identifier
unii: 92RU3N3Y1O
Seedlings Diaper Rash CreamZINC OXIDEYoung Living Essential Oils, LC.4d8aeaba-ddb1-6f74-e054-00144ff88e882026-05-08WarningsExact identifier
unii: SOI2LOH54Z
PlenamineLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINEB. Braun Medical Inc.a3244d1a-45b0-4e4c-bd96-f0632d761a1f2026-05-08Warnings, Adverse reactionsExact identifier
unii: 94ZLA3W45F
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmerisource Bergen566dbd02-5e04-4461-8f5f-9fb58a42a3752026-05-07WarningsExact identifier
unii: 3G6A5W338E
Back and Body Extra StrengthASPIRIN, CAFFEINEDOLGENCORP, LLCd4c0c81b-9176-47d0-a5e4-a584406078d92026-05-07WarningsExact identifier
unii: 3G6A5W338E
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbb65c8d7-318f-4d52-9d74-ca22ce3896382026-05-07WarningsExact identifier
unii: 15FIX9V2JP
Ciele lip and PROTECT lipstick SPF 60 CassetteCIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTELE COSMETICS INC5139cc37-62ac-514b-e063-6394a90a9ca32026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Ciele lip and PROTECT lipstick SPF 60 KellyCIELE LIP AND PROTECT LIPSTICK SPF 60 KELLYLE COSMETICS INC5139d3c1-83d1-2ad9-e063-6394a90a69582026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Ciele lip and PROTECT lipstick SPF 60 MargauxCIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUXLE COSMETICS INC5138eb74-0223-6c1f-e063-6294a90a3bc62026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Ciele lip and PROTECT lipstick SPF 60 BonnieCIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIELE COSMETICS INC513a0449-5494-5dfd-e063-6394a90a026e2026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Ciele lip and PROTECT lipstick SPF 60 LouLouCIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOULE COSMETICS INC5139dab1-3c27-a59e-e063-6294a90a70962026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Ciele lip and PROTECT lipstick SPF 60 PuzzleCIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLELE COSMETICS INC513a0722-42ab-1051-e063-6294a90a8a1d2026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Ciele lip and PROTECT lipstick SPF 60 SaddleCIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLELE COSMETICS INC513a12cf-0230-6a24-e063-6394a90afb952026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Zinc Oxide 20.00%SPF 50 MINERALCoconut Caliente Costa Rica LLC388f1e01-0feb-4c94-88a7-13c81368c6c82026-05-07WarningsExact identifier
unii: SOI2LOH54Z
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MENSTRUAL RELIEFACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDa44a5cf4-e88a-4da9-907a-8d8497c7d79d2026-05-07WarningsExact identifier
unii: 3G6A5W338E
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: PDC6A3C0OX
unii: 2KR89I4H1Y
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior67b90f00-4c82-40cd-af96-f8dedf95f8af2026-05-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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