Avedana Pain Relieving Roll On

Product NDC
43749-310
11-digit product format
437490310
Labeler code
43749
Product ID
43749-310_e362d7b9-9e5e-d240-e053-2a95a90aca72
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Unipack LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-09-29
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
40 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43749-310-032024-01-30C16284748780-11030e365-1d4d-111a-e063-dadaa90a10e2Avedana ® Pain Relief Roll-On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43749-310-03Avedana Pain Relieving Roll On89 mL in 1 BOTTLE, WITH APPLICATORGEL896

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETAVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AAVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETAVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3AAVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626QAVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZWAVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1
BOSWELLIA SERRATA RESIN OILINACTIVE INGREDIENT5T1XCE6K8KAVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27EAVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FAVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RAVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43749-310AVEDANA PAIN RELIEVING ROLL ON (MENTHOL) GEL [UNIPACK LLC]6Legacy NDC, 1 package rows20220710_59256eea-2a78-4065-82b7-ac81283c2a3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1550540camphor 0.4 % / menthol 3.5 % Roll On Topical GelPSN59256eea-2a78-4065-82b7-ac81283c2a3e6
1550540camphor 0.004 MG/MG / menthol 0.035 MG/MG Topical GelSCD59256eea-2a78-4065-82b7-ac81283c2a3e6
1550540camphor 0.4 % / menthol 3.5 % Topical GelSY59256eea-2a78-4065-82b7-ac81283c2a3e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43749-310-034374903100389 mL in 1 BOTTLE, WITH APPLICATOR (43749-310-03) 89 ml2017-09-170000-00-00NoNoCurrent