FDA.reportPublic FDA data

Isopropyl alcohol

Product NDC
55319-277
11-digit product format
553190277
Labeler code
55319
Product ID
55319-277_baed1690-159d-4023-830f-44a7f82f0f3c
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-06-30
Marketing end
0000-00-00
Substance
ISOPROPYL ALCOHOL
Active strength
91 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55319-277DDiscontinued by firm2026-10-12
excluded packagepackage55319-27755319-277-16DDiscontinued by firm2026-10-12
excluded packagepackage55319-27755319-277-32DDiscontinued by firm2026-10-12

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, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55319-277-32fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55319-277-16fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55319-277-3286f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55319-277-1686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55319-277-32bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55319-277-16bd6a592717d7…303034d00443…

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
55319-277-162023-01-23Drug Facts
55319-277-322023-01-23Drug Facts
55319-277-162022-01-28Drug Facts
55319-277-322022-01-28Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302ISOPROPYL ALCOHOL 91 PERCENT (ISOPROPYL ALCOHOL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]2
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302ISOPROPYL ALCOHOL 91 PERCENT (ISOPROPYL ALCOHOL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]2
WATERINACTIVE INGREDIENT059QF0KO0RISOPROPYL ALCOHOL 91 PERCENT (ISOPROPYL ALCOHOL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-277ISOPROPYL ALCOHOL 91 PERCENT (ISOPROPYL ALCOHOL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]8Legacy NDC20240117_e9614ca9-bbeb-4eba-8bfc-7351cf16b252.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-277-1655319027716473 mL in 1 BOTTLE, PLASTIC (55319-277-16) 473 ml2014-06-300000-00-00NoNoCurrent
55319-277-3255319027732946 mL in 1 BOTTLE, PLASTIC (55319-277-32) 946 ml2014-06-300000-00-00NoNoCurrent