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 9 of 10 · 189 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UNDA 10ABSINTHIUM, ARGENTUM METALLICUM, EQUISETUM ARVENSE, JUNIPERUS COMMUNIS, MILLEFOLIUM, RHAMNUS FRANGULASeroyal USA20ea57db-ad94-2c1c-e054-00144ff88e882022-11-08WarningsExact identifier
unii: 2FXJ6SW4PK
Unda 11ASPARAGUS OFFICINALIS YOUNG SHOOT, MENTHA PIPERITA WHOLE PLANT, MILLEFOLIUM WHOLE PLANT,THYMUS SERPYLLUM WHOLE PLANT, CROCUS SATIVUS DRIED STIGMA, ROSMARINUS OFFICINALIS FLOWERING TWIGS, GLECHOMA HEDERACEA WHOLE PLANT, VERBENA OFFICINALIS WHOLE PLANT, UVA-URSI LEAF, CUPRUM METALLICUMSeroyal USA0fd85527-b04b-3f4a-e054-00144ff8d46c2022-11-08WarningsExact identifier
unii: 2FXJ6SW4PK
Unda 1ACHILLEA MILLEFOLIUMSeroyal USA03c2e772-efa0-5a69-e054-00144ff88e882022-11-07WarningsExact identifier
unii: 2FXJ6SW4PK
Arnica WellBELLIS PERENNIS, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, MILLEFOLLIUM MT, CHAMOMILLA, FERRUM PHOSPHORICUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, APIS MELLIFICA, ARNICA MONTANA, BELLADONNA, SYMPHYTUM OFFICINALE, HYPERICUM PERFORATUM.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics 05258499752647581-e65c-4f43-bb61-600174bc8e7e2021-12-29WarningsExact identifier
unii: 2FXJ6SW4PK
TrauleviumBELLADONNA, ARNICA MONTANA RADIX, ACONITUM NAPELLUS, CHAMOMILLA, SYMPHYTUM OFFICINALE, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, MILLEFOLIUM, HEPAR SULPHURIS CALCAREUM, MERCURIUS SOLUBILIS, HYPERICUM PERFORATUM, BELLIS PERENNIS, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA.Medical Technology Products, Inc.6123d145-4edf-4ecd-8b30-196e522731272021-12-29WarningsExact identifier
unii: 2FXJ6SW4PK
TrauleviumARNICA MONTANA RADIX, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA, ECHINACEA PURPUREA, CHAMOMILLA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MILLEFOLIUM, ACONITUM NAPELLUS, BELLADONNA, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM.Medical Technology Products, Inc.797f448f-a4c7-4c7a-980d-7c3b074e64992021-12-29WarningsExact identifier
unii: 2FXJ6SW4PK
TRAULEVIUM Pain Relief DropsARNICA RAD, ACONITUM NAP, CHAMOMILLA, BELLADONNA, SYMPHYTUM, BELLIS, CALENDULA, ECHINACEA, ECHINACEA PURP, HAMAMELIS, HYPERICUM, MILLEFOLIUM, HEPAR SULPH CALC, MERC SOLUB.Medical Technology Products, Inc.1f9efd2d-16e2-4c34-b62a-3745d3c53c6b2021-12-29WarningsExact identifier
unii: 2FXJ6SW4PK
Traulevium Pain Relief GelARNICA MONTANA, CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA, ECHINACEA PURPUREA, CHAMOMILLA, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MILLEFOLIUM, ACONITUM NAPELLUS, BELLADONNA, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM.Medical Technology Products, Inc.692daf7a-11e2-4f08-bdcf-1b9ac866d2132021-12-29WarningsExact identifier
unii: 2FXJ6SW4PK
Dr. Talbots Pain Inflammation ReliefARNICA, BELLIS PERENNIS, CALENDULA OFFICINALIS, CHAMOMILLA, COFFEA CRUDA, HYPERICUM, MILLEFOLIUM, FERRUM PHOSPHORICUM, KALI MURIATICUM, MAGNESIA PHOSPHORICATalbot's Pharmaceuticals Family Products, LLC.91d57aae-7c68-cc4a-e053-2995a90aad9d2021-10-05WarningsExact identifier
unii: 2FXJ6SW4PK
BUX GUARDCITRONELLA OILAloe Vera Korea Co.,Ltd.c8b1a32d-4c4f-5c9f-e053-2995a90a78882021-07-29WarningsExact identifier
unii: ZBP1YXW0H8
HPTPARNICA MONTANA, ACHILLEA MILLEFOLIUM, ERIGERON CANADENSIS, HYDRASTIS CANADENSIS, ORYCTOLAGUS CUNICULUS, SABINA, SECALE CORNUTUMSeroyal USA23078896-9618-084c-e054-00144ff88e882021-07-22WarningsExact identifier
unii: 2FXJ6SW4PK
UNDA 4LAURUS NOBILIS, CONDURANGO, RHAMNUS FRANGULA, MENYANTHES TRIFOLIATA, ABSINTHIUM, JATEORHIZA PALMATA, ARGENTUM METALLICUM, ANTIMONIUM CRUDUMSeroyal USA1777c76b-5329-3c7b-e054-00144ff88e882021-07-15WarningsExact identifier
unii: 2FXJ6SW4PK
UNDA 5TORMENTILLA, TUSSILAGO FARFARA, ADIANTUM CAPILLUS-VENERIS, GLYCYRRHIZA GLABRA, DROSERA, GRINDELIA, INULA HELENIUM, CUPRUM METALLICUM, ARGENTUM METALLICUMSeroyal USA1789ed21-3bc9-3b86-e054-00144ff88e882021-07-15WarningsExact identifier
unii: 2FXJ6SW4PK
Unda 3EQUISETUM ARVENSE STEM, CHAMOMILLA, CONDURANGO BARK, VIOLA TRICOLOR, BOLDO LEAF, ALUMINIUM METALLICUM, STANNUM METALLICUMSeroyal USA1583cf73-c22c-0fa8-e054-00144ff8d46c2021-07-15WarningsExact identifier
unii: 2FXJ6SW4PK
HemorrhoidsELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, ECHINACEA, SOLIDAGO, URTICA UR.Newton Laboratories, Inc.c6f30a27-ae7f-2574-e053-2995a90a91022021-07-12WarningsExact identifier
unii: 2FXJ6SW4PK
CO COOLMENTHOL, PEPPERMINT OIL, PINUS PUMILIO BRANCH/LEAF OILLydia Co., Ltd.90b213fe-f7b9-555c-e053-2a95a90a1df32021-06-27WarningsExact identifier
unii: AV092KU4JH
HemorrhoidsELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, ECHINACEA, SOLIDAGO, URTICA UR.Newton Laboratories, Inc.c69eaaf5-b8d4-708b-e053-2a95a90ae6d12021-03-15WarningsExact identifier
unii: 2FXJ6SW4PK
HemorrhoidsELAPS CORALLINUS, AESCULUS HIPP., ALOE, ARSENICUM ALB., BRYONIA, CALC. FLUOR., CAPSICUM, COLLINSONIA, CROTALUS HORRIDUS, HAMAMELIS, HYDROFLUORICUM ACIDUM, HYPERICUM, LACHESIS, LYCOPODIUM, MILLEFOLIUM, NAJA, NUX VOM., PAEONIA, PLANTAGO, QUERCUS GLANDIUM SPIRITUS, RATANHIA, VIPERA BERUS, ECHINACEA, SOLIDAGO, URTICA UR.Newton Laboratories, Inc.c69f4926-c5c9-63a0-e053-2a95a90a2ca62021-03-15WarningsExact identifier
unii: 2FXJ6SW4PK
GUNA THROAT AND GUMSACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - WITCH HAZEL -Guna spaba484531-ef7a-17ed-e053-2995a90a50b32021-02-17WarningsExact identifier
unii: 2FXJ6SW4PK
Mega MensesAPIS MELLIFICA, HAMAMELIS VIRGINIANA, HYDRASTIS CANADENSIS, ALETRIS FARINOSA, APOCYNUM CANNABINUM, CINCHONA OFFICINALIS, CINNAMOMUM, CONIUM MACULATUM, HELONIAS DIOICA, LILIUM TIGRINUM, MILLEFOLIUM, PHOSPHORUS, SECALE CORNUTUM, THLASPI BURSA-PASTORIS, TRILLIUM PENDULUM.Newton Laboratories, Inc.9a646b7e-23dd-c2e5-e053-2995a90a66c12020-12-04WarningsExact identifier
unii: 2FXJ6SW4PK

Reported adverse events (FAERS/openFDA)#

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