FDA.reportPublic FDA data

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581662Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
428b1cb9-7db8-3141-e054-00144ff8d46cAvailable on FDA.report

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

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
SpectrumETHYL ALCOHOLMedline Industries, LP428b1cb9-7db8-3141-e054-00144ff8d46c2026-02-10WarningsExact identifier
ndc (product): 53329-009

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