FDA.reportPublic FDA data

Stressa Back and Neck Pain Relieving

Manufacturer
Stressa Incorporated
Effective date
2014-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:39:57

Label at a glance#

ProductStressa Back and Neck Pain Relieving
Active ingredientMenthol
Label structure8 sections

Indications and uses

For the temporary relief of pain associated with simple backache strains bruises sprains

Dosage and administration

Adults and children 2 years of age and older : Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.25%

Purpose

OTC - PURPOSE SECTION

topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain associated with

  • simple backache
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • do not bandage tightly,

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • conditions worsen or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: Consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

almond oil, alpha tocopherol (vitamin E), apricot kernel oil, arabica coffee oil, basil oil, cananga oil, european hazelnut oil, galbanum oil, hyssop oil, lemon juice, methyl salicylate, nutmeg oil, picea mariana leaf oil, pine needle oil (pinus sylvestris), rosemary oil, sage oil, wheat germ

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stressa™

back & neck
pain relieving oil

all natural formula
for the soothing relief
of tense and sore
muscles

NET WT
8 fl oz (240 mL)

Principal Display Panel - 240 mL Bottle Label
Principal Display Panel - 240 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1545293menthol 1.25 % Topical OilPSN1
1545293menthol 12.5 MG/ML Topical OilSCD1
1545293menthol 1.25 % Topical OilSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53882-002-012019-11-27C16284748780-19855e2a2-4fc2-60a7-e053-dbdaa90a05bdStressa ™ Back & Neck Pain Relieving Oil
53882-002-022019-11-27C16284748780-19855e2a2-4fc2-60a7-e053-dbdaa90a05bdStressa ™ Back & Neck Pain Relieving Oil
53882-002-032019-11-27C16284748780-19855e2a2-4fc2-60a7-e053-dbdaa90a05bdStressa ™ Back & Neck Pain Relieving Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53882-002-01Stressa Back and Neck Pain Relieving60 mL in 1 BOTTLE, PLASTICOIL601
53882-002-02Stressa Back and Neck Pain Relieving118 mL in 1 BOTTLE, PLASTICOIL1181
53882-002-03Stressa Back and Neck Pain Relieving240 mL in 1 BOTTLE, PLASTICOIL2401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53882-002STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]1Legacy NDC, 3 package rows20140813_8dc5dbff-a4d5-4b81-825b-25691cf9ac0f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3A1
MentholACTIVE MOIETYL7T10EIP3A1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
ALMOND OILINACTIVE INGREDIENT66YXD4DKO91
APRICOT KERNEL OILINACTIVE INGREDIENT54JB35T06A1
ARABICA COFFEE OILINACTIVE INGREDIENTIK55HKE8871
BASIL OILINACTIVE INGREDIENTZ129UMU8LE1
CANANGA OILINACTIVE INGREDIENT8YOY78GNNX1
EUROPEAN HAZELNUT OILINACTIVE INGREDIENT8RQ2839AVG1
GALBANUM OILINACTIVE INGREDIENT211UF7M8N11
HYSSOP OILINACTIVE INGREDIENT173D71924B1
LEMON OILINACTIVE INGREDIENTI9GRO824LL1
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022Y1
NUTMEG OILINACTIVE INGREDIENTZ1CLM489481
PICEA MARIANA LEAF OILINACTIVE INGREDIENTQ1J49L1A5O1
PINE NEEDLE OIL (PINUS SYLVESTRIS)INACTIVE INGREDIENT5EXL5H740Y1
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM3931
SAGE OILINACTIVE INGREDIENTU27K0H1H2O1
WHEAT GERMINACTIVE INGREDIENTYR3G369F5A1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53882-00253882-002-01, 53882-002-02, 53882-002-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
MentholL7T10EIP3AACTIB
ALMOND OIL66YXD4DKO9IACT
APRICOT KERNEL OIL54JB35T06AIACT
BASIL OILZ129UMU8LEIACT
ARABICA COFFEE OILIK55HKE887IACT
GALBANUM OIL211UF7M8N1IACT
EUROPEAN HAZELNUT OIL8RQ2839AVGIACT
HYSSOP OIL173D71924BIACT
LEMON OILI9GRO824LLIACT
NUTMEG OILZ1CLM48948IACT
ROSEMARY OIL8LGU7VM393IACT
SAGE OILU27K0H1H2OIACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT
PICEA MARIANA LEAF OILQ1J49L1A5OIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
WHEAT GERMYR3G369F5AIACT
METHYL SALICYLATELAV5U5022YIACT
CANANGA OIL8YOY78GNNXIACT

Source Document#

Source XML

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 · 26 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLSUSPENSION / ORAL1 mgExact identifier — unii candidate
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YCAPSULE / ORAL16 mgExact identifier — unii candidate
8 equally ranked IID candidates
NUTMEG OILNUTMEG OILZ1CLM48948LIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
2 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
ALMOND OILALMOND OIL66YXD4DKO9CREAM / TOPICAL2 %w/wExact identifier — unii candidate
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPASTE, DENTIFRICE / DENTAL1.1 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YTABLET / ORAL10 mgExact identifier — unii candidate
8 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLPASTE, DENTIFRICE / DENTAL0.7 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
NUTMEG OILNUTMEG OILZ1CLM48948ELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
8 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLCAPSULE / ORAL8.5 mgExact identifier — unii candidate
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YLOZENGE / ORAL53 mgExact identifier — unii candidate
8 equally ranked IID candidates
PINE NEEDLE OIL (PINUS SYLVESTRIS)PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YLOTION / TOPICAL0.25 %w/wExact identifier — unii candidate
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YDOUCHE / VAGINAL0.05 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates

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
11f9d65c-4717-4802-a8d9-921d4006c9ae8dc5dbff-a4d5-4b81-825b-25691cf9ac0f2014-08-04WarningsExact identifier
spl id: 11f9d65c-4717-4802-a8d9-921d4006c9ae
spl set id: 8dc5dbff-a4d5-4b81-825b-25691cf9ac0f

Reported adverse events (FAERS/openFDA)#

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