Dr. Blue

Product NDC
10578-131
11-digit product format
105780131
Labeler code
10578
Product ID
10578-131_3b057467-ca8c-48c2-99ad-80a012b5f74b
Type
HUMAN OTC DRUG
Nonproprietary name
menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Indiana Botanic Gardens
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-11-01
Substance
MENTHOL
Active strength
4.58 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dr. Blue
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4.58 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1549850Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1b1150bd-e087-4d8f-b0d6-0d935cf6e31eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10578-131-02Dr. Blue57 g in 1 TUBEGEL571
10578-131-05Dr. Blue142 g in 1 JARGEL1421

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10578-131DR. BLUE (MENTHOL) GEL [INDIANA BOTANIC GARDENS]1Current NDC, Legacy NDC, 2 package rows20161111_1b1150bd-e087-4d8f-b0d6-0d935cf6e31e.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
Dr. BlueMENTHOLIndiana Botanic Gardens1b1150bd-e087-4d8f-b0d6-0d935cf6e31e2016-11-01WarningsExact identifier
ndc (product): 10578-131

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1549850menthol 4.6 % Topical GelPSN1b1150bd-e087-4d8f-b0d6-0d935cf6e31e1
1549850menthol 0.046 MG/MG Topical GelSCD1b1150bd-e087-4d8f-b0d6-0d935cf6e31e1
1549850menthol 4.6 % Topical GelSY1b1150bd-e087-4d8f-b0d6-0d935cf6e31e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10578-131-021057801310257 g in 1 TUBE (10578-131-02) 57 g2016-11-010000-00-00NoNoCurrent
10578-131-0510578013105142 g in 1 JAR (10578-131-05) 142 g2016-11-010000-00-00NoNoCurrent