FDA.reportPublic FDA data

Cold and Hot

Manufacturer
CVS | Product Quest Mfg, LLC
Effective date
2018-05-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:55:29

Label at a glance#

ProductCold and Hot CVS
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure8 sections

Dosage and administration

 • shake well • adults and children 2 years of age and older: spray product on affected area, not more than 3 to 4 times daily. • children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 7.60%
Methyl Salicylate 29.00%


Purpose

OTC - PURPOSE SECTION

Topical analgesic

INDICATIONS & USAGE SECTION

Uses

For the temporary relief of minor aches and pains of muscles and
joints associated with: • arthritis • simple backache • muscle strains
• bruises • sprains

Warnings

WARNINGS SECTION

For external use only.

Flammable • keep away from fire or flame • do not use while smoking or
near heat or flame • avoid long term storage above 104˚F. • do not puncture
or incinerate. Contents under pressure. • do not store at temperatures
above 120˚F.
When using this product • avoid contact with eyes and mucous
membranes • do not apply to wounds or damaged skin • do not bandage
tightly • use only as directed
Stop use and ask doctor if • condition worsens • symptoms persist for
more than 7 days or clear up and occur again within a few days • needed for
longer than 1 week
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

 • shake well • adults and children 2 years of age and older:
spray product on affected area, not more than 3 to 4 times
daily. • children under 2 years of age: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat.
Arnica Montana Flower Extract
Boswellia Serrata Gum Extract
Dimethyl Sulfone
Eucalyptus Globulus Leaf Oil
Ilex Paraguariensis Leaf Extract
Mentha Piperita (Peppermint) Oil
Olea Europaea (Olive) Fruit Oil
Propylene Glycol
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1596759menthol 7.6 % / methyl salicylate 29 % Topical SprayPSN4
1596759menthol 76 MG/ML / methyl salicylate 290 MG/ML Topical SpraySCD4
1596759menthol 7.6 % / methyl salicylate 29 % Topical SpraySY4

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
59779-269-042020-01-31C16284748780-19d75b9d0-d51c-f424-e053-dadaa90a57ce4d499e0c-cb59-4af4-aabb-58c5318f1dee

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-269-04Cold and HotCVS113 g in 1 CANSPRAY1134

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-269COLD AND HOT CVS (MENTHOL 7.6% MEHYL SALICYLATE 29.0%) SPRAY [CVS]4Legacy NDC, 1 package rows20180510_4d499e0c-cb59-4af4-aabb-58c5318f1dee.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y1
MENTHOLACTIVE MOIETYL7T10EIP3A1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZ1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FT1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6621
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4F1
INDIAN FRANKINCENSEINACTIVE INGREDIENT4PW41QCO2M1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59779-26959779-269-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
EUCALYPTUS OIL2R04ONI662IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
OLIVE OIL6UYK2W1W1EIACT
Propylene Glycol6DC9Q167V3IACT

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 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCONCENTRATE / ORAL0.05 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSYRUP / ORAL120 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSUSPENSION / ORAL100 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHELIXIR / ORAL0.04 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCAPSULE / ORAL60 mgExact identifier — unii candidate
21 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / SUBLINGUAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / DENTAL0.04 %v/vExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / ORAL53 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / ORAL28 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHLOZENGE / ORAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPOWDER / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / ORAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / BUCCAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSPRAY, METERED / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPASTE, DENTIFRICE / DENTAL49.3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM / BUCCAL12 mgExact identifier — unii candidate
21 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
5f0d9ce2-a850-4b91-a9e2-5747dd49c8c64d499e0c-cb59-4af4-aabb-58c5318f1dee2018-05-10WarningsExact identifier
spl id: 5f0d9ce2-a850-4b91-a9e2-5747dd49c8c6
spl set id: 4d499e0c-cb59-4af4-aabb-58c5318f1dee

Reported adverse events (FAERS/openFDA)#

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