FDA.reportPublic FDA data

Alo Therapeutic Massage

Product NDC
51457-000
11-digit product format
514570000
Labeler code
51457
Product ID
51457-000_09d7052e-ec73-ef60-e063-6294a90af214
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
2012-06-07
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
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
Rxcui1300288, 1300293

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51457-000-04Alo Therapeutic Massage118 g in 1 TUBECREAM1184

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HISTAMINE DIHYDROCHLORIDEACTIVE INGREDIENT3POA0Q644UALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]1
HISTAMINEACTIVE MOIETY820484N8I3ALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]1
MENTHOLACTIVE MOIETYL7T10EIP3AALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]1
SPEARMINT OILINACTIVE INGREDIENTC3M81465G5ALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]1
WATERINACTIVE INGREDIENT059QF0KO0RALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51457-000ALO THERAPEUTIC MASSAGE (MENTHOL, HISTAMINE DIHYDROCHLORIDE) CREAM [THERAPLEX SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20231111_a898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1300293Alo (histamine dihydrochloride 0.1 % / menthol 3 % ) Topical CreamPSNa898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d44
1300288histamine dihydrochloride 0.1 % / menthol 3 % Topical CreamPSNa898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d44
1300293histamine dihydrochloride 1 MG/ML / menthol 30 MG/ML Topical Cream [Alo]SBDa898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d44
1300288histamine dihydrochloride 1 MG/ML / menthol 30 MG/ML Topical CreamSCDa898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d44
1300293Alo (histamine dihydrochloride 0.1 % / menthol 3 % ) Topical CreamSYa898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d44
1300288histamine dihydrochloride 0.1 % / menthol 3 % Topical CreamSYa898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51457-000-0451457000004118 g in 1 TUBE (51457-000-04) 118 g2017-02-030000-00-00NoNoCurrent