FDA.reportPublic FDA data

Mag 5 PT Cooling Formula Recovery Cream

Product NDC
76348-510
11-digit product format
763480510
Labeler code
76348
Product ID
76348-510_43e53829-1764-6b61-e063-6394a90a53de
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
RENU LABORATORIES, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-19
Substance
MENTHOL
Active strength
22.7 g/454g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mag 5 PT Cooling Formula Recovery Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL22.7 g/454g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-510-162025-03-25C16284748780-12cef2736-6d23-d83d-e063-dadaa90ab31fMAG 5 PT COOLING FORMULA RECOVERY CREAM
76348-510-162025-01-30C16284748780-12cef2736-6d23-d83d-e063-dadaa90ab31fMAG 5 PT COOLING FORMULA RECOVERY CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-510-04Mag 5 PT Cooling Formula Recovery Cream112 g in 1 JARCREAM1128
76348-510-05Mag 5 PT Cooling Formula Recovery Cream1 in 1 BOXCREAM18
76348-510-16Mag 5 PT Cooling Formula Recovery Cream454 g in 1 JARCREAM4548

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-510MAG 5 PT COOLING FORMULA RECOVERY CREAM (MENTHOL) CREAM [RENU LABORATORIES, LLC]7Current NDC, Legacy NDC, 3 package rows20250330_a45cde67-64ec-643b-e053-2a95a90a10b6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76348-510-0476348051004112 g in 1 JAR112 gHistorical
76348-510-05763480510051 JAR in 1 BOX (76348-510-05) / 112 g in 1 JAR (76348-510-04) 1 jar2019-03-19NoNoHistorical
76348-510-1676348051016454 g in 1 JAR (76348-510-16) 454 g2019-03-19NoNoHistorical