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
Label	Manufacturer	Effective date	Type
Anti Itch Balm - US ORGANIC GROUP CORP \| LEORARD MOON	US ORGANIC GROUP CORP \| LEORARD MOON	2013-03-29	HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57285-100-02	2019-11-27	C162847	48780-1	9855d018-ed2c-cd31-e053-dbdaa90ab51a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57285-100-01	Anti Itch Balm	28 g in 1 JAR	OINTMENT	28		3
57285-100-02	Anti Itch Balm	1 in 1 CARTON	OINTMENT	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57285-100	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3	Legacy NDC, 2 package rows	20130329_c0cb1412-8a46-4f41-9162-10e6f7237ef9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Peppermint Oil	ACTIVE INGREDIENT	AV092KU4JH	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
Peppermint	ACTIVE MOIETY	V95R5KMY2B	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
ACHILLEA MILLEFOLIUM	INACTIVE INGREDIENT	2FXJ6SW4PK	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
CHAMAEMELUM NOBILE FLOWER OIL	INACTIVE INGREDIENT	UB27587839	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
CHAMOMILE FLOWER OIL	INACTIVE INGREDIENT	60F80Z61A9	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
EVENING PRIMROSE OIL	INACTIVE INGREDIENT	3Q9L08K71N	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
FRANKINCENSE OIL	INACTIVE INGREDIENT	67ZYA5T02K	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
ROSEMARY OIL	INACTIVE INGREDIENT	8LGU7VM393	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
TAMANU OIL	INACTIVE INGREDIENT	JT3LVK84A1	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	ANTI ITCH BALM (PEPPERMINT OIL) OINTMENT [US ORGANIC GROUP CORP]	3
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	ANTI 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 10 of 10 · 189 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menstrual - PMS	ANGELICA SINENSIS RADIX, ARSENICUM ALB., BRYONIA, CAULOPHYLLUM, CIMICIFUGA, CINCHONA, DIOSCOREA, FOLLICULINUM, GELSEMIUM, LACHESIS, LILIUM, LYCOPODIUM, MILLEFOLIUM, NUX VOM., PULSATILLA, SABINA, SECALE, SEPIA,THLASPI, VIBURNUM OP., ZINGIBER, ECHINACEA, VALERIANA	Newton Laboratories, Inc.	99602037-4650-0c3d-e053-2995a90a37b6	2020-12-04	Warnings	Exact identifier unii: 2FXJ6SW4PK
GUNA PAIN MANAGEMENT	ACHILLEA MILLEFOLIUM WHOLE - BELLIS PERENNIS WHOLE - MATRICARIA CHAMOMILLA WHOLE - TOXICODENDRON PUBESCENS WHOLE - RUTA GRAVEOLENS FLOWERING TOP - COMFREY ROOT - APIS MELLIFERA - BRYONIA ALBA ROOT - HISTAMINE HYDROCHLORIDE - HYPERICUM PERFORATUM - KALMIA LATIFOLIA LEAF - ARNICA MONTANA WHOLE - PORK LIVER -	Guna spa	af5bad63-6d57-2260-e053-2995a90afb7e	2020-09-15	Warnings	Exact identifier unii: 2FXJ6SW4PK
GUNA-ORAL	ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - SUS SCROFA TOOTH - WITCH HAZEL -	Guna spa	f1b8e5ab-8689-4bf2-a6d9-863d02f29579	2018-12-21	Warnings	Exact identifier unii: 2FXJ6SW4PK
ANTI AGE SKIN	ALPHA-TOCOPHEROL - ASCOPHYLLUM NODOSUM - BOTRYOGLOSSUM PLATYCARPUM - FUCUS SERRATUS - FUCUS VESICULOSUS - ISOLEUCINE - LEUCINE - RETINOL - SELENIUM - SUS SCROFA CAPILLARY TISSUE - SUS SCROFA COLLAGEN - SUS SCROFA PLACENTA - SUS SCROFA SKIN - UBIDECARENONE - ULVA LACTUCA EXTRACT - LAMINARIA DIGITATA	Guna spa	f0c53be7-01ac-40ed-b3cd-8911ba704346	2018-12-21	Warnings	Exact identifier unii: H4N855PNZ1
Hemorrhoid Gel	ACHILLEA MILLEFOLIUM, AESCULUS HIPPOCASTANUM, HAMAMELIS VIRGINIANA, RUSCUS ACULEATUS, ALOE SOCOTRINA, PAEONIA OFFICINALIS, IGNATIA AMARA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PEITATUM, PULSATILLA, RATANHIA, CHELIDONIUM MAJUS, SULPHUR	Natural Creations, Inc	d2016513-9b47-490d-9396-766db4cafecd	2018-12-21	Warnings	Exact identifier unii: 2FXJ6SW4PK
Bacteria Chord	AZADIRACHTA INDICA, BELLADONNA, BERBERIS VULGARIS, BOLDO, CANDIDA ALBICANS, CEANOTHUS AMERICANUS, CETRARIA ISLANDICA, CROTALUS HORRIDUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HAMAMELIS VIRGINIANA, HEPAR SUIS, HYDRASTIS CANADENSIS, HYDROCOTYLE ASIATICA, HYPERICUM PERFORATUM, LAPPA MAJOR, LEDUM PALUSTRE, MILLEFOLIUM, MORBILLINUM, MYRRHA, PANCREAS SUIS, PERTUSSINUM, PHOSPHORUS, PLANTAGO MAJOR, PYROGENIUM, SOLIDAGO VIRGAUREA, ZINGIBER OFFICINALE	Energetix Corp	f12539de-a737-437e-9392-727208275ba1	2018-07-11	Warnings	Exact identifier unii: 2FXJ6SW4PK
Test Flex	AVENA SATIVA, CALCAREA CARBONICA, DAMIANA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, MAGNESIA CARBONICA, MILLEFOLIUM, SABAL SERRULATA, THUJA OCCIDENTALIS, URTICA URENS	Safe Anabolic Sciences	fed38357-f3b7-42f0-9367-eaf97e15c059	2017-08-17	Warnings	Exact identifier unii: 2FXJ6SW4PK
Eagle Brand Medicated Roll On Refresh	CAMPHOR, MENTHOL	Borden Company (Private) Limited	567b6820-fb52-630e-e063-6294a90a8bf8	2015-07-01	Warnings	Exact identifier unii: AV092KU4JH
7aff6e22-67f3-408c-adcc-e2978f1c1508			c0cb1412-8a46-4f41-9162-10e6f7237ef9	2013-03-29	Warnings	Exact identifier spl id: 7aff6e22-67f3-408c-adcc-e2978f1c1508 spl set id: c0cb1412-8a46-4f41-9162-10e6f7237ef9

Reported adverse events (FAERS/openFDA)#

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