Painzaway Pain Relieving Gel

Product NDC
10578-135
11-digit product format
105780135
Labeler code
10578
Product ID
10578-135_2927e7a0-4cb0-3592-e063-6294a90a9fac
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Indiana Botanic Gardens
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-19
Substance
MENTHOL
Active strength
4.6 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
Painzaway Pain Relieving Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4.6 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui1549850

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10578-135-05Painzaway Pain Relieving Gel57 g in 1 JARGEL572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10578-135PAINZAWAY PAIN RELIEVING GEL (MENTHOL) GEL [INDIANA BOTANIC GARDENS]2Current NDC, Legacy NDC, 1 package rows20241215_dba1d268-ebab-0ac7-e053-2a95a90ad4b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1549850menthol 4.6 % Topical GelPSNdba1d268-ebab-0ac7-e053-2a95a90ad4b62
1549850menthol 0.046 MG/MG Topical GelSCDdba1d268-ebab-0ac7-e053-2a95a90ad4b62
1549850menthol 4.6 % Topical GelSYdba1d268-ebab-0ac7-e053-2a95a90ad4b62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10578-135-051057801350557 g in 1 JAR (10578-135-05) 57 g2022-04-190000-00-00NoNoCurrent