FDA.reportPublic FDA data

ANIOSGEL 85

Product NDC
62169-203
Requested package NDC
62169-203-12
11-digit product format
621690203
Labeler code
62169
Product ID
62169-203_530314cb-fd9a-465d-af15-8ce5c5f4f454
Type
HUMAN OTC DRUG
Nonproprietary name
Ethanol
Dosage form
GEL
Route
TOPICAL
Labeler
Laboratoires Anios
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-04-01
Marketing end
2027-08-31
Substance
ALCOHOL
Active strength
377.5 mL/500mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ANIOSGEL 85
Brand name suffix
NPC

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL377.5 mL/500mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ee820cd-2dca-40d5-bd96-bbd54131c2f0Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62169-203-122020-02-03C16284748780-19d75b9d0-ed79-f424-e053-dadaa90a57ce5ee820cd-2dca-40d5-bd96-bbd54131c2f0
62169-203-122020-01-31C16284748780-19d75b9d0-ed79-f424-e053-dadaa90a57ce5ee820cd-2dca-40d5-bd96-bbd54131c2f0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62169-203-12ANIOSGEL 85NPC12 in 1 PACKAGEGEL1212
62169-203-17ANIOSGEL 85NPC500 mL in 1 BOTTLE, PLASTICGEL50012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MANIOSGEL 85 NPC (ETHANOL) GEL [LABORATOIRES ANIOS]3
ALCOHOLACTIVE MOIETY3K9958V90MANIOSGEL 85 NPC (ETHANOL) GEL [LABORATOIRES ANIOS]3
GlycerinINACTIVE INGREDIENTPDC6A3C0OXANIOSGEL 85 NPC (ETHANOL) GEL [LABORATOIRES ANIOS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62169-203ANIOSGEL 85 NPC (ETHANOL) GEL [LABORATOIRES ANIOS]12Current NDC, Legacy NDC, 2 package rows20250213_5ee820cd-2dca-40d5-bd96-bbd54131c2f0.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
ANIOSGEL 85 NPCETHANOLLaboratoires Anios5ee820cd-2dca-40d5-bd96-bbd54131c2f02025-02-11WarningsExact identifier
ndc (package): 62169-203-12
ndc (product): 62169-203
ndc11 (package): 62169020312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62169-203-126216902031212 BOTTLE, PLASTIC in 1 PACKAGE (62169-203-12) / 500 mL in 1 BOTTLE, PLASTIC (62169-203-17) 2018-03-072027-08-31NoNoCurrent