FDA.reportPublic FDA data

Azuro

Product NDC
49955-100
11-digit product format
499550100
Labeler code
49955
Product ID
49955-100_1f8fe83c-fcaf-489e-b0b8-01817ee2a81a
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Noveko Inc
Application
part333
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-11-18
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
1 L/L
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49955-100-102019-10-21C16284748780-1956f9ecf-df6b-621f-e053-dbdaa90a74add920cf43-356d-43e6-af53-6b5f754fc8e4
49955-100-132019-10-21C16284748780-1956f9ecf-df6b-621f-e053-dbdaa90a74add920cf43-356d-43e6-af53-6b5f754fc8e4
49955-100-252019-10-21C16284748780-1956f9ecf-df6b-621f-e053-dbdaa90a74add920cf43-356d-43e6-af53-6b5f754fc8e4
49955-100-502019-10-21C16284748780-1956f9ecf-df6b-621f-e053-dbdaa90a74add920cf43-356d-43e6-af53-6b5f754fc8e4
49955-100-602019-10-21C16284748780-1956f9ecf-df6b-621f-e053-dbdaa90a74add920cf43-356d-43e6-af53-6b5f754fc8e4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49955-100-10Azuro1 L in 1 BOTTLEGEL13
49955-100-13Azuro1.3 L in 1 BOTTLEGEL1.33
49955-100-25Azuro0.25 L in 1 BOTTLEGEL0.253
49955-100-50Azuro0.5 L in 1 BOTTLEGEL0.53
49955-100-60Azuro0.06 L in 1 BOTTLEGEL0.063

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MAZURO (ALCOHOL) GEL [NOVEKO INC]3
ALCOHOLACTIVE MOIETY3K9958V90MAZURO (ALCOHOL) GEL [NOVEKO INC]3
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NAZURO (ALCOHOL) GEL [NOVEKO INC]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XAZURO (ALCOHOL) GEL [NOVEKO INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAZURO (ALCOHOL) GEL [NOVEKO INC]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKAZURO (ALCOHOL) GEL [NOVEKO INC]3
WATERINACTIVE INGREDIENT059QF0KO0RAZURO (ALCOHOL) GEL [NOVEKO INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49955-100AZURO (ALCOHOL) GEL [NOVEKO INC]3Legacy NDC, 5 package rows20100106_d920cf43-356d-43e6-af53-6b5f754fc8e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNd920cf43-356d-43e6-af53-6b5f754fc8e43
581662ethanol 0.7 ML/ML Topical GelSCDd920cf43-356d-43e6-af53-6b5f754fc8e43
581662ethanol 70 % Topical GelSYd920cf43-356d-43e6-af53-6b5f754fc8e43
581662ethyl alcohol 70 % Topical GelSYd920cf43-356d-43e6-af53-6b5f754fc8e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49955-100-10499550100101 L in 1 BOTTLE1 lHistorical
49955-100-13499550100131.3 L in 1 BOTTLE1.3 lHistorical
49955-100-25499550100250.25 L in 1 BOTTLE0.25 lHistorical
49955-100-50499550100500.5 L in 1 BOTTLE0.5 lHistorical
49955-100-60499550100600.06 L in 1 BOTTLE0.06 lHistorical