FDA.reportPublic FDA data

Isopropyl Alcohol

Product NDC
36800-071
Requested package NDC
36800-071-16
11-digit product format
368000071
Labeler code
36800
Product ID
36800-071_6d486f98-f5c2-46d8-b270-22917f009901
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
TOP CARE (Topco Associates LLC)
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-10-31
Marketing end
0000-00-00
Substance
ISOPROPYL ALCOHOL
Active strength
50 mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage36800-07136800-071-16DDiscontinued 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 · 4 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05YUnknown FDA exclusion code: Y110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
36800-071-252021-07-239d75b9cf-d0d9-f424-e053-dadaa90a57ceAnti - Fungal Powder
36800-071-252021-02-229d75b9cf-d0d9-f424-e053-dadaa90a57ceAnti - Fungal Powder
36800-071-162021-02-209d75b9d0-e2ff-f424-e053-dadaa90a57ceDrug Facts
36800-071-162020-01-319d75b9d0-e2ff-f424-e053-dadaa90a57ceDrug Facts
36800-071-252020-01-319d75b9cf-d0d9-f424-e053-dadaa90a57ceAnti - Fungal Powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-071-25Miconazole Nitrate71 g in 1 BOTTLE, PLASTICPOWDER711

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302ISOPROPYL ALCOHOL 50 PERCENT (ISOPROPYL ALCOHOL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302ISOPROPYL ALCOHOL 50 PERCENT (ISOPROPYL ALCOHOL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1
WATERINACTIVE INGREDIENT059QF0KO0RISOPROPYL ALCOHOL 50 PERCENT (ISOPROPYL ALCOHOL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-071ISOPROPYL ALCOHOL 50 PERCENT (ISOPROPYL ALCOHOL) LIQUID [TOP CARE (TOPCO ASSOCIATES LLC)]8Legacy NDC20241115_03fc2595-20bd-4863-bd6f-d80f23be7e11.zip
36800-071MICONAZOLE NITRATE (ANTI-FUNGAL POWDER MICONAZOLE NITRATE) POWDER [TOPCO ASSOCIATES LLC]1Legacy NDC, 1 package rows20160401_7ac90517-7d9b-4d94-b1c9-b424ad907a59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN7ac90517-7d9b-4d94-b1c9-b424ad907a591
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD7ac90517-7d9b-4d94-b1c9-b424ad907a591
998461miconazole nitrate 2 % Topical PowderSY7ac90517-7d9b-4d94-b1c9-b424ad907a591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-071-1636800007116473 mL in 1 BOTTLE, PLASTIC (36800-071-16) 473 ml2014-10-310000-00-00NoNoCurrent