FDA.reportPublic FDA data

SEDLAV

Product NDC
84361-0002
11-digit product format
843610002
Labeler code
84361
Product ID
84361-0002_413c0a03-cf5b-908e-e063-6294a90a7a6a
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Instock Distributing
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-06-01
Substance
ISOPROPYL ALCOHOL
Active strength
2650 mL/3785mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
SEDLAV
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL2650 mL/3785mL

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
1b31e3dc-31f3-dffe-e063-6394a90a1c96Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84361-0002-2SEDLAV3785 mL in 1 BOTTLELIQUID37854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84361-0002SEDLAV (ISOPROPYL ALCOHOL) LIQUID [INSTOCK DISTRIBUTING]2Current NDC, 1 package rows20240701_1b31e3dc-31f3-dffe-e063-6394a90a1c96.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SEDLAVISOPROPYL ALCOHOLInstock Distributing1b31e3dc-31f3-dffe-e063-6394a90a1c962025-10-15WarningsExact identifier
ndc (product): 84361-0002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN1b31e3dc-31f3-dffe-e063-6394a90a1c964
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD1b31e3dc-31f3-dffe-e063-6394a90a1c964
808520isopropyl alcohol 70 % Topical SolutionSY1b31e3dc-31f3-dffe-e063-6394a90a1c964

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84361-0002-2843610002023785 mL in 1 BOTTLE (84361-0002-2) 3785 ml2024-06-01NoNoCurrent