FDA.reportPublic FDA data

Isopropyl Alcohol 70 Percent With Wintergreen Oil

Product NDC
82645-915
11-digit product format
826450915
Labeler code
82645
Product ID
82645-915_0d6ccefd-6382-35fb-e063-6294a90adf31
Type
HUMAN OTC DRUG
Nonproprietary name
isopropyl alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Pharma Nobis, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-01
Substance
ISOPROPYL ALCOHOL
Active strength
700 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Isopropyl Alcohol 70 Percent With Wintergreen Oil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL700 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
808520Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e42f6c6d-c4e1-02c6-e053-2995a90a3aceAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-915-16Isopropyl Alcohol 70 Percent With Wintergreen Oil473 mL in 1 BOTTLELIQUID4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-915ISOPROPYL ALCOHOL 70 PERCENT WITH WINTERGREEN OIL (ISOPROPYL ALCOHOL) LIQUID [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 1 package rows20231227_e42f6c6d-c4e1-02c6-e053-2995a90a3ace.zip

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 24 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tigerherbs Natural Healing CreamBEDSORE CREAMShenzhen Yao Yu Technology Co., LTD392c3666-b86e-9266-e063-6394a90ae5022026-04-25WarningsExact identifier
application number: M003
MISTIFY WHIPPED STRAWBERRY HYDRATING HAND SANITISERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5006097e-16e6-d180-e063-6394a90ae0c22026-04-22WarningsExact identifier
application number: M003
Sanitizing Wipes LavenderALCOHOLThe Honest Company Inc.4a69b1d5-81ad-2cd1-e063-6294a90ac62d2026-04-22WarningsExact identifier
application number: M003
Sanitizing Wipes GrapefruitALCOHOLThe Honest Company Inc.4aa8c899-e5c3-9eec-e063-6294a90a6eae2026-04-22WarningsExact identifier
application number: M003
3M Skin and Nasal AntisepticPOVIDONE-IODINESolventum US LLC1a94494d-7dd3-4f32-bc42-81c199fe233e2026-04-22WarningsExact identifier
application number: M003
3M Avagard DALCOHOLSolventum US LLC220c8a49-2a52-4660-8ad4-de553bd032262026-04-22WarningsExact identifier
application number: M003
Santa and Friends Hand Sanitizers Santa Cookies, Caramel Vanilla Snuggle, Frosted Marshmallow, Winterberry CrumbleALCOHOL SPRAYScent Theory Products LLC4ffa6e26-870f-586e-e063-6394a90ad9752026-04-21WarningsExact identifier
application number: M003
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.4fcf2c05-9bd2-2813-e063-6294a90a44012026-04-19WarningsExact identifier
application number: M003
Solar Flare Sunlit Holiday Hand Sanitizers (Golden Caramel, Vanilla Solstice, Amber Rose)ALCOHOL SPRAYScent Theory Products LLC4fc170dd-7c6b-b810-e063-6394a90ae61f2026-04-18WarningsExact identifier
application number: M003
Megababe - Squeaky Clean Hand SanitizerETHYL ALCOHOLMEGABABE, LLC249e00ef-fe9d-dc07-e063-6394a90a9f4c2026-04-16WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCIProstat First Aid4f9adbac-5497-e7be-e063-6294a90a75182026-04-16WarningsExact identifier
application number: M003
Megababe - Squeaky Clean Hand SanitizerETHYL ALCOHOLMEGABABE, LLC2d940d35-6a73-e494-e063-6394a90a9d162026-04-14WarningsExact identifier
application number: M003
Freskaro Povidone IodinePOVIDONE IODINE 10%Pharma Nobis, LLC4f711d3b-5ed6-5dd4-e063-6294a90afeaa2026-04-14WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLPerrigo Direct, Incec43a3f5-c5f3-439b-8764-ca92fefb45c92026-04-10Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEWalmart Inc.ebd02cd3-75cc-444b-8284-d28733a2855b2026-04-10Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMSC Industrial Supplyb248ad4a-ed92-4d03-b0da-9639c46e19492026-04-10Warnings, Adverse reactionsExact identifier
application number: M003
Smart Care Hand Sanitizer Sunset GuavaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f01fc3a-5b01-4b6b-e063-6294a90aefb42026-04-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Fresh RainALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f02adaa-1440-5778-e063-6294a90a344a2026-04-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Watermelon WaveALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f031f62-e56c-9063-e063-6394a90af9c12026-04-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk with Leather CaseALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f036ba3-3f21-d04b-e063-6294a90ad7d72026-04-09WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808520isopropyl alcohol 70 % Topical SolutionPSNe42f6c6d-c4e1-02c6-e053-2995a90a3ace2
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCDe42f6c6d-c4e1-02c6-e053-2995a90a3ace2
808520isopropyl alcohol 70 % Topical SolutionSYe42f6c6d-c4e1-02c6-e053-2995a90a3ace2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82645-915-1682645091516473 mL in 1 BOTTLE (82645-915-16) 473 ml2016-01-010000-00-00NoNoCurrent