Spectrum

Product NDC
53329-009
11-digit product format
533290009
Labeler code
53329
Product ID
53329-009_4a7f93a8-9649-5855-e063-6294a90ad299
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Medline Industries, LP
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-15
Substance
ALCOHOL
Active strength
70 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Spectrum
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581662

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53329-009-022022-08-16C16284748780-1e4f33bdf-b19c-d8a0-e053-dadaa90a6e4e009 Spectrum Advanced 70% Packet
53329-009-022022-07-29C16284748780-1e4f33bdf-b19c-d8a0-e053-dadaa90a6e4e009 Spectrum Advanced 70% Packet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-009-02Spectrum2.4 mL in 1 PACKETGEL2.47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-009SPECTRUM (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, LP]6Current NDC, Legacy NDC, 1 package rows20240531_428b1cb9-7db8-3141-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN428b1cb9-7db8-3141-e054-00144ff8d46c7
581662ethanol 0.7 ML/ML Topical GelSCD428b1cb9-7db8-3141-e054-00144ff8d46c7
581662ethanol 70 % Topical GelSY428b1cb9-7db8-3141-e054-00144ff8d46c7
581662ethyl alcohol 70 % Topical GelSY428b1cb9-7db8-3141-e054-00144ff8d46c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-009-02533290009022.4 mL in 1 PACKET (53329-009-02) 2.4 ml2016-08-150000-00-00NoNoCurrent