FDA.reportPublic FDA data

NDC 57285-100-01 - Anti Itch Balm

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
57285-100
Requested NDC
57285-100-01
Package NDCs from labels
57285-100-01, 57285-100-02
Manufacturer
US ORGANIC GROUP CORP | LEORARD MOON
Effective date
2013-03-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Anti Itch Balm - US ORGANIC GROUP CORP | LEORARD MOONUS ORGANIC GROUP CORP | LEORARD MOON2013-03-29HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57285-100-022019-11-27C16284748780-19855d018-ed2c-cd31-e053-dbdaa90ab51aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57285-100-01Anti Itch Balm28 g in 1 JAROINTMENT283
57285-100-02Anti Itch Balm1 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57285-100ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3Legacy NDC, 2 package rows20130329_c0cb1412-8a46-4f41-9162-10e6f7237ef9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Peppermint OilACTIVE INGREDIENTAV092KU4JHANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3
PeppermintACTIVE MOIETYV95R5KMY2BANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3
ACHILLEA MILLEFOLIUMINACTIVE INGREDIENT2FXJ6SW4PKANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3
CHAMAEMELUM NOBILE FLOWER OILINACTIVE INGREDIENTUB27587839ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3
CHAMOMILE FLOWER OILINACTIVE INGREDIENT60F80Z61A9ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3
EVENING PRIMROSE OILINACTIVE INGREDIENT3Q9L08K71NANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3
FRANKINCENSE OILINACTIVE INGREDIENT67ZYA5T02KANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3
JOJOBA OILINACTIVE INGREDIENT724GKU717MANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM393ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3
TAMANU OILINACTIVE INGREDIENTJT3LVK84A1ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]3

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 8 of 10 · 189 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
T-ReliefACHILLEA MILLEFOLIUM, HYPERICUM PERFORATUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA, UNSPECIFIED, MATRICARIA RECUTITA, ATROPA BELLADONNA,COMFREY ROOT, ACONITUM NAPELLUS, BELLIS PERENNIS,ARNICA MONTANA, AND RUTA GRAVEOLENS FLOWERING TOPMediNatura Inc1fcfd0a5-b4ff-4546-e054-00144ff8d46c2023-09-27WarningsExact identifier
unii: 2FXJ6SW4PK
T-Relief Extra Strength CreamARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA UNSPECIFIED, ACONITUM NAPELLUS, ACHILLEA MILLEFOLIUM, HAMAMELIS VIRGINIANA ROOT BARK STEM BARK, MATRICARIA CHAMOMILLA, ATROPA BELLADONNA, BELLIS PERENNIS, RUTA GRAVEOLENS FLOWERING TOP, BAPTISIA TINCTORIA ROOT, COMFREY ROOT AND HYPERICUM PERFORATUMMediNatura Inc12f6cf2f-a924-42b1-9ca0-c360c7a592442023-09-27WarningsExact identifier
unii: 2FXJ6SW4PK
T-ReliefACONITUM NAPELLUS, ARNICA MONTANA, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA UNSPECIFIED, HAMAMELIS VIRGINIANA ROOT BARK STEM BARK, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Incedb2fe62-e990-4cef-8600-9d1b85bffa5a2023-09-27WarningsExact identifier
unii: 2FXJ6SW4PK
TraumeelACONITUM NAPELLUS, ARNICA MONTANA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, HYPERICUM PERFORATUM, MERCURIUS SOLUBILIS, ACHILLEA MILLEFOLIUM AND COMFREY ROOTMediNatura Incc9962e63-3c30-4c62-9caf-91f663c7eeaa2023-09-26WarningsExact identifier
unii: 2FXJ6SW4PK
T-Relief Extra StrengthARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING, HAMAMELIS VIRGINIANA ROOT BARK/STEM, BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS, ECHINACEA, UNSPECIFIED, ACONITUM NAPELLUS, MATRICARIA CHAMOMILLA, ACHILLEA MILLEFOLIUM, ATROPA BELLADONNA, HYPERICUM PERFORATUM, RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc97959b87-690d-45c1-9319-c17cdfa850202023-09-18WarningsExact identifier
unii: 2FXJ6SW4PK
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: H4N855PNZ1
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: K49155WL9Y
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
unii: VIF565UC2G
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: K49155WL9Y
MillefoliumMILLEFOLIUMTrue Botanica, LLCfe7cee16-3320-eed9-e053-6294a90a7f012023-06-19WarningsExact identifier
unii: 2FXJ6SW4PK
Tree AntigenTEA TREE ESSENTIAL OIL, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS).BioActive Nutritional, Inc.c6b0f199-e44e-4892-b56b-766cf0bc4b622023-06-07WarningsExact identifier
unii: VIF565UC2G
T-ReliefARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc2bd442ca-0bbe-0bc3-e054-00144ff8d46c2023-03-21WarningsExact identifier
unii: 2FXJ6SW4PK
TraumedARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc8cd4745f-2f4b-4cdf-868b-c5a089a165992023-03-21WarningsExact identifier
unii: 2FXJ6SW4PK
TraumexARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc335c8bec-f0c3-4b95-a6a6-5fda262be0e62023-03-20WarningsExact identifier
unii: 2FXJ6SW4PK
TraumeelACONITUM NAPELLUS, ARNICA MONTANA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, HYPERICUM PERFORATUM, MERCURIUS SOLUBILIS, ACHILLEA MILLEFOLIUM AND COMFREY ROOTBiologische Heilmittel Heel9ff5c743-0e8f-4416-9964-c92b3abb54dd2023-03-06WarningsExact identifier
unii: 2FXJ6SW4PK
MillefoliumACHILLEA MILLEFOLIUMBoiron692163d8-42cf-3edb-e053-2991aa0a3d0c2023-02-20Exact identifier
unii: 2FXJ6SW4PK
VULPURSILVER NITRATE, ARMORACIA RUSTICANA WHOLE, CINNAMOMUM VERUM WHOLE, WOOD CREOSOTE, CAPSELLA BURSA-PASTORIS, CALENDULA OFFICINALIS FLOWERING TOP, ACHILLEA MILLEFOLIUM, AND SALVIA OFFICINALIS FLOWERING TOPPEKANA Naturheilmittel GmbH19425603-1b4c-4e2c-8980-032b2de98fe82022-12-20WarningsExact identifier
unii: 2FXJ6SW4PK
Telomere - DNACA98, CAROTENOID, DNA, GLUTATHIONE, OMEGA 3, PITUITARUM, RNA, VITAMIN B COMPLEX, VITAMIN C, VITAMIN D3, VITAMIN EProBLENb093dfba-ed48-47a2-b4ce-f706221935a12022-11-30WarningsExact identifier
unii: H4N855PNZ1
Immune SupportARSENICUM ALBUM, RUMEX, SQUILLA MARITIMA, BRYONIA ALBA, KALI CARBONICUM, GLUTATHIONE, VITAMIN C, VITAMIN C, ZINC PICOLINATE, VITAMIN B, VITAMIN E, BETA GLUCAN, CURCUMIN, GRAPEFRUIT SEED, OREGANO LEAF, GARLIC BULB, OLIVE LEAF, APPLE CIDER VINEGAR, ASTRAGALUS ROOT, MAITAKE MUSHROOM, CATS CLAW BARKProBLENe6f26cf4-dc3d-4d31-aa3e-145167b6ba2b2022-11-30WarningsExact identifier
unii: H4N855PNZ1
Unda 228VALERIANA OFFICINALIS ROOT, MELISSA OFFICINALIS WHOLE PLANT, VERBENA OFFICINALIS WHOLE PLANT, MILLEFOLIUM WHOLE PLANT, THYMUS VULGARIS AERIAL PARTS, PASSIFLORA INCARNATA AERIAL PARTS, LACTUCA VIROSA WHOLE PLANTSeroyal USA0a6f8408-bdbc-09c6-e054-00144ff88e882022-11-09WarningsExact identifier
unii: 2FXJ6SW4PK

Reported adverse events (FAERS/openFDA)#

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