FDA.reportPublic FDA data

ALO THERAPEUTIC MASSAGE PAIN RELIEVING

Product NDC
51457-001
11-digit product format
514570001
Labeler code
51457
Product ID
51457-001_09d72589-13fd-349f-e063-6294a90a4d95
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, HISTAMINE DIHYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Theraplex Solutions
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-03-20
Substance
HISTAMINE DIHYDROCHLORIDE; MENTHOL
Active strength
.1; 3 g/100g; 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
ALO THERAPEUTIC MASSAGE PAIN RELIEVING
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HISTAMINE DIHYDROCHLORIDE.1 g/100g
MENTHOL3 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3POA0Q644U, L7T10EIP3A

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51457-001-32ALO THERAPEUTIC MASSAGE PAIN RELIEVING1 in 1 PACKAGECREAM14
51457-001-32ALO THERAPEUTIC MASSAGE PAIN RELIEVING907.18474 g in 1 BOTTLECREAM907.184744

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51457-001ALO THERAPEUTIC MASSAGE PAIN RELIEVING (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]4Current NDC, Legacy NDC, 2 package rows20231111_da004500-5e48-487b-b96f-520a3094096c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51457-001-32514570001321 BOTTLE in 1 PACKAGE (51457-001-32) / 907.18474 g in 1 BOTTLE1 bottle2017-02-220000-00-00NoNoCurrent