FDA.reportPublic FDA data

D-Germ

Product NDC
65585-498
11-digit product format
655850498
Labeler code
65585
Product ID
65585-498_0c052697-8b05-596c-e063-6394a90a94a9
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Whisk Products, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-13
Substance
ALCOHOL
Active strength
600 mL/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
D-Germ
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL600 mL/L

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
581658Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe08fb0c-007c-40a7-e053-6294a90acac9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65585-498-01D-Germ0.118 L in 1 BOTTLE, PLASTICGEL0.1182
65585-498-02D-Germ0.473 L in 1 BOTTLE, PUMPGEL0.4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65585-498D-GERM (ALCOHOL) GEL [WHISK PRODUCTS, INC.]2Current NDC, 2 package rows20231209_fe08fb0c-007c-40a7-e053-6294a90acac9.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
D-GermALCOHOLWhisk Products, Inc.fe08fb0c-007c-40a7-e053-6294a90acac92023-12-08WarningsExact identifier
ndc (product): 65585-498

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581658ethanol 60 % Topical GelPSNfe08fb0c-007c-40a7-e053-6294a90acac92
581658ethanol 0.6 ML/ML Topical GelSCDfe08fb0c-007c-40a7-e053-6294a90acac92
581658ethanol 60 % Topical GelSYfe08fb0c-007c-40a7-e053-6294a90acac92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65585-498-0165585049801.118 L in 1 BOTTLE, PLASTIC (65585-498-01) 2023-06-13NoNoCurrent
65585-498-0265585049802.473 L in 1 BOTTLE, PUMP (65585-498-02) 2023-06-13NoNoCurrent