FDA.reportPublic FDA data

ORIGINAL HEALING

Manufacturer
PUREMEDY
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:25:35

Label at a glance#

ProductORIGINAL HEALING
Active ingredientSAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, ECHINACEA ANGUSTIFOLIA
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

ORG. SAMBUCUS NIGRA (1X) HPUS (ELDER BARK AND FLOWER)

ORG. CALENDULA OFFICINALIS (1X) HPUS) (MARIGOLD)

ORG. ECHINACEA ANGUST. (1X) HPUS (ECHINACEA)

OTC - PURPOSE SECTION

PROPERTIES

SKIN PROTECTANT

ANTI-INFLAMMATORY

PROMOTES SKIN HEALING

REMEDY FOR WOUNDS

INDICATIONS & USAGE SECTION

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH SKIN IRRITATIONS, WOUNDS, BOILS, CUTS, ITCH, BURNS, TOPICAL INFECTION, AND A WIDE VARIETY OF SKIN AILMENTS.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: APPLY TO AFFECTED AREA 2-4 TIMES PER DAY OR AS NEEDED. COVER WITH A BANDAID OR TELFA BANDAGE IF NECESSARY. DO NOT DRESS WITH GAUZE.

INACTIVE INGREDIENT SECTION

OTHER INGREDIENTS: ORG. EXTRA VIRGIN OLIVE OIL, ORG. BEESWAX, FIR BALSAM RESIN

WARNINGS SECTION

WARNING: TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN FIRST. DO NOT USE IF ALLERGIC TO OR HYPER-SENSITIVE TO ANY INGREDIENT IN THIS SALVE. IF CONDITION PERSISTS OR WORSENS CONSULT YOUR HEALTH CARE PROVIDER. (* = CERTIFIED ORGANIC INGREDIENTS)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

OTC - QUESTIONS SECTION

CUSTOMER SERVICE 310-526-6108

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original 1 ozOriginal 1 oz

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52810-213-112025-07-29C16284748780-19855e2a2-515a-60a7-e053-dbdaa90a05bdORIGINAL HEALING (52810-213)
52810-213-112020-04-16C16284748780-19855e2a2-515a-60a7-e053-dbdaa90a05bdORIGINAL HEALING (52810-213)
52810-213-112019-11-27C16284748780-19855e2a2-515a-60a7-e053-dbdaa90a05bdORIGINAL HEALING (52810-213)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52810-213-11ORIGINAL HEALING30 mL in 1 JARSALVE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52810-213ORIGINAL HEALING (SAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, ECHINACEA ANGUSTIFOLIA) SALVE [PUREMEDY]8Legacy NDC, 1 package rows20240112_0fa96fef-e6ae-43d7-a7ee-7677b7f19954.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERACTIVE INGREDIENTP0M7O4Y7YD2
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US82
SAMBUCUS NIGRA FLOWERACTIVE INGREDIENT07V4DX094T2
CALENDULA OFFICINALIS FLOWERACTIVE MOIETYP0M7O4Y7YD2
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US82
SAMBUCUS NIGRA FLOWERACTIVE MOIETY07V4DX094T2
CANADA BALSAMINACTIVE INGREDIENTK304VI98I32
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E2
PINE NEEDLE OIL (PINUS SYLVESTRIS)INACTIVE INGREDIENT5EXL5H740Y2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52810-21352810-213-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
OLIVE OIL6UYK2W1W1EIACT
CANADA BALSAMK304VI98I3IACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT
SAMBUCUS NIGRA FLOWER07V4DX094TACTIB
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CANADA BALSAMCANADA BALSAMK304VI98I3LOTION / TOPICAL0.5 %w/wExact identifier — unii candidate
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCREAM / TOPICAL5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
PINE NEEDLE OIL (PINUS SYLVESTRIS)PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YLOTION / TOPICAL0.25 %w/wExact identifier — unii candidate

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0eb2eaa2-f957-5876-e063-6394a90ac52d0fa96fef-e6ae-43d7-a7ee-7677b7f199542024-01-11WarningsExact identifier
spl id: 0eb2eaa2-f957-5876-e063-6394a90ac52d
spl set id: 0fa96fef-e6ae-43d7-a7ee-7677b7f19954

Reported adverse events (FAERS/openFDA)#

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