FDA.reportPublic FDA data

Isopropyl alcohol

Product NDC
49580-0271
Requested package NDC
49580-0271-6
11-digit product format
495800271
Labeler code
49580
Product ID
49580-0271_1c1e3437-7376-4377-920f-a73076d96eb6
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
P & L Development, LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-06-30
Marketing end
0000-00-00
Substance
ISOPROPYL ALCOHOL
Active strength
50 mL/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49580-027149580-0271-6DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
49580-0271-22023-05-17Drug Facts
49580-0271-32023-05-17Drug Facts
49580-0271-62023-05-17Drug Facts
49580-0271-22023-01-30Drug Facts
49580-0271-32023-01-30Drug Facts
49580-0271-62023-01-30Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302ISOPROPYL ALCOHOL 50 PERCENT READYINCASE (ISOPROPYL ALCOHOL) LIQUID [AARON INDUSTRIES INC.]3
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302ISOPROPYL ALCOHOL 50 PERCENT READYINCASE (ISOPROPYL ALCOHOL) LIQUID [AARON INDUSTRIES INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RISOPROPYL ALCOHOL 50 PERCENT READYINCASE (ISOPROPYL ALCOHOL) LIQUID [AARON INDUSTRIES INC.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49580-0271-649580027106473 mL in 1 BOTTLE, PLASTIC (49580-0271-6) 473 ml2014-06-300000-00-00NoNoCurrent