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 6 of 10 · 189 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OrgaPlus Super Care Balm for combination and oi ly skin type 14gSUNFLOWERBLUEZONWIDE CO.,LTD10b39828-8a9c-44b0-aa2a-925a5593e8ab2025-02-05WarningsExact identifier
unii: 3W1JG795YI
OrgaPlus Super Care Balm for combination and oi ly skin type 20gSUNFLOWERBLUEZONWIDE CO.,LTD676e4d9f-62bc-4983-81fe-0d314ef468742025-02-05WarningsExact identifier
unii: 3W1JG795YI
Progena ImmugenARALIA QUINQUEFOLIA, ECHINACEA, PHYTOLACCA DECANDRA, ASCORBIC ACID, BETA CAROTENE, GLANDULA SUPRARENALIS, PYRIDOXINUM HYDROCHLORICUM, SPLEEN, THYMUS, SELENIUM METALLICUM, VITAMIN E, ZINCUM METALLICUMMeditrend, Inc. DBA Progena Professional Formulations6df039e8-b6e8-489f-87de-af71efd1f7b72025-01-29WarningsExact identifier
unii: H4N855PNZ1
Bestmade Natural Products BM46ACONITE, BELLADONNA, CHAMOMILLA, MAG PHOS, MERC SOL, MILLEFOLIUM, STAPHYSAGRIABestmade Natural Products2c62e63a-fe82-a463-e063-6394a90a65ee2025-01-23WarningsExact identifier
unii: 2FXJ6SW4PK
CeleragesicECHINACEA (ANGUSTIFOLIA), CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA PURPUREA, BELLIS PERENNIS, CHAMOMILLA, HYPERICUM PERFORATUM, MILLEFOLIUM, LEDUM PALUSTRE, ARNICA MONTANA, BRYONIA (ALBA), NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALE, RHUS TOX, ACONITUM NAPELLUS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUMDeseret Biologicals, Inc.1a3edb9d-e571-4275-b56e-d2489da11e762025-01-14WarningsExact identifier
unii: 2FXJ6SW4PK
D-30STRONTIUM SALICYLATE, METHENAMINE, COLCHICUM AUTUMNALE BULB, BLACK COHOSH, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, SOLANUM DULCAMARA WHOLE, HYPERICUM PERFORATUM, STRYCHNOS NUX-VOMICA SEED, ATROPA BELLADONNA, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ACHILLEA MILLEFOLIUM, AND TOXICODENDRON PUBESCENS LEAFDNA Labs, Inc.0e74e654-4bda-4969-89be-8ab89014bce22025-01-13WarningsExact identifier
unii: 2FXJ6SW4PK
D82ACHILLEA MILLEFOLIUM, ARNICA MONTANA, HYPERICUM PERFORATUM, HORSE CHESTNUT, AND VISCUM ALBUM WHOLEDNA Labs, Inc.2c24bb97-11be-450a-9cf9-5aadca1e8be12025-01-13WarningsExact identifier
unii: 2FXJ6SW4PK
N-27ARNICA MONTANA, MILK THISTLE, SUS SCROFA CEREBRUM, CINCHONA OFFICINALIS BARK, GINKGO BILOBA WHOLE, LECITHIN, SOYBEAN, LITHIUM CARBONATE, ACHILLEA MILLEFOLIUM, PHOSPHORIC ACID, PORK BRAIN, ALNUS GLUTINOSA WHOLE, AND ROSMARINUS OFFICINALIS FLOWERING TOPDNA Labs, Inc.df2d7683-3b45-4ddb-9b67-7bb74dad28542025-01-09WarningsExact identifier
unii: 2FXJ6SW4PK
Body Milk for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,BUTYROSPERMUM PARKII (SHEA) BUTTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,THEOBROMA CACAO (COCOA) SEED BUTTERGuangzhou Senmai Biotechnology Co.1dcd94dc-214d-de72-e063-6294a90a695f2025-01-08WarningsExact identifier
unii: 3W1JG795YI
unii: K49155WL9Y
Body oil for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILGuangzhou Senmai Biotechnology Co.1daeb2e8-f18c-06c3-e063-6294a90a63852025-01-08WarningsExact identifier
unii: 3W1JG795YI
Massage cream for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL,BUTYROSPERMUM PARKII (SHEA) BUTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,CERAMIDE NP,SOLUBLE COLLAGEN,HYDROLYZED ELASTIN,PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OILGuangzhou Senmai Biotechnology Co.1dce7cf1-1fb8-e14e-e063-6394a90ae34a2025-01-08WarningsExact identifier
unii: 3W1JG795YI
unii: K49155WL9Y
AOAO Retinol Anti-aging Box SetCOLLAGEN,BUTYROSPERMUM PARKII (SHEA) BUTTER EXTRACT,HYALURONIC ACID,CAFFEINE,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,RETINOL.Guangdong Junhui Biotechnology Co., LTD24fdc31b-5291-a649-e063-6394a90a9c652025-01-08WarningsExact identifier
unii: K49155WL9Y
unii: 724GKU717M
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
unii: AV092KU4JH
Vital Brain EnergyARNICA MONTANA, CARDUUS MARIANUS, CEREBRUM SUIS, CINCHONA OFFICINALIS, GINKGO BILOBA, LECITHIN, MILLEFOLIUM, PHOSPHORICUM ACIDUMLiddell Laboratories, Inc.39446d61-bf75-44d1-8291-55c37911e21f2024-11-04WarningsExact identifier
unii: 2FXJ6SW4PK
Chavita 7AUR MET, CALC SULF, CEREBRUM, HYPERICUM PERFORATUM, LACHESIS MUTUS, MILLEFOLIUM, VALERIANARUBIMED AGf827befd-e66e-4023-b43e-0d35b6f4319d2024-10-29WarningsExact identifier
unii: 2FXJ6SW4PK
Emvita 26ARSENICUM ALB, CEREBRUM, LYCOPODIUM, MILLEFOLIUM, PLUMB METRUBIMED AG15c31884-fae8-4148-8d17-311e0d66c0812024-10-29WarningsExact identifier
unii: 2FXJ6SW4PK
Trauma ReliefCHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), HAMAMELIS VIRGINIANA, HYPERICUM PERFORATUM, MILLEFOLIUM, CALENDULA OFFICINALIS, ARNICA MONTANA, BELLADONNA, BELLIS PERENNIS, CLEMATIS VITALBA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PRUNUS CERASIFERA, FLOS, SYMPHYTUM OFFICINALE, RHUS TOX, BRYONIA (ALBA), HEPAR SULPHURIS CALCAREUM, CARBO VEGETABILISDeseret Biologicals, Inc.651f998a-c150-4f38-8582-b9bd971409102024-10-22WarningsExact identifier
unii: 2FXJ6SW4PK
CeleragesicECHINACEA (ANGUSTIFOLIA), CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA PURPUREA, BELLIS PERENNIS, CHAMOMILLA, HYPERICUM PERFORATUM, MILLEFOLIUM, LEDUM PALUSTRE, ARNICA MONTANA, BRYONIA (ALBA), HEPAR SULPHURIS CALCAREUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALE, RHUS TOX, ACONITUM NAPELLUS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUISDeseret Biologicals, Inc.aa8f0dd4-4a3e-49ab-85cf-e4a5f48cdbf52024-10-22WarningsExact identifier
unii: 2FXJ6SW4PK
CeleragesicECHINACEA (ANGUSTIFOLIA), CALENDULA OFFICINALIS, HAMAMELIS VIRGINIANA, ECHINACEA PURPUREA, BELLIS PERENNIS, CHAMOMILLA, HYPERICUM PERFORATUM, MILLEFOLIUM, LEDUM PALUSTRE, ARNICA MONTANA, BRYONIA (ALBA), HEPAR SULPHURIS CALCAREUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALE, RHUS TOX, ACONITUM NAPELLUS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUISDeseret Biologicals, Inc.d3d8a7f4-169c-4780-852d-c96a4772e7e32024-10-22WarningsExact identifier
unii: 2FXJ6SW4PK
Injury TopicalCALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, CARBO VEGETABILIS, HAMAMELIS VIRGINIANA, MILLEFOLIUM, RHUS TOX, RUTA GRAVEOLENS, VERATRUM ALBUMBioActive Nutritional, Inc.c5ed8876-d419-41db-9af3-42d76e1c562e2024-10-17WarningsExact identifier
unii: 2FXJ6SW4PK

Reported adverse events (FAERS/openFDA)#

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