FDA.reportPublic FDA data

Instaflex Pain Relief Cream

Product NDC
70015-665
11-digit product format
700150665
Labeler code
70015
Product ID
70015-665_51a0db5e-9e53-71c2-e063-6394a90a1bb2
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Healthy Directions, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-01
Substance
MENTHOL
Active strength
12.5 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Instaflex Pain Relief Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL12.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui416982

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70015-665-012024-01-30C16284748780-11030e365-35e7-111a-e063-dadaa90a10e2Instaflex Pain Relief Cream
70015-665-022024-01-30C16284748780-11030e365-35e7-111a-e063-dadaa90a10e2Instaflex Pain Relief Cream
70015-665-042024-01-30C16284748780-11030e365-35e7-111a-e063-dadaa90a10e2Instaflex Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70015-665-01Instaflex Pain Relief Cream28 g in 1 TUBECREAM283
70015-665-01Instaflex Pain Relief Cream1 in 1 CARTONCREAM13
70015-665-02Instaflex Pain Relief Cream1 in 1 CARTONCREAM13
70015-665-02Instaflex Pain Relief Cream57 g in 1 TUBECREAM573
70015-665-04Instaflex Pain Relief Cream113 g in 1 TUBECREAM1133
70015-665-04Instaflex Pain Relief Cream1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70015-665INSTAFLEX PAIN RELIEF CREAM (MENTHOL) CREAM [HEALTHY DIRECTIONS, LLC]2Current NDC, Legacy NDC, 6 package rows20200611_665b847a-9cfb-49fc-975b-81c97f936575.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416982menthol 1.25 % Topical CreamPSN665b847a-9cfb-49fc-975b-81c97f9365753
416982menthol 12.5 MG/ML Topical CreamSCD665b847a-9cfb-49fc-975b-81c97f9365753
416982menthol 1.25 % Topical CreamSY665b847a-9cfb-49fc-975b-81c97f9365753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70015-665-01700150665011 TUBE in 1 CARTON (70015-665-01) / 28 g in 1 TUBE1 tube2020-06-100000-00-00NoNoCurrent
70015-665-02700150665021 TUBE in 1 CARTON (70015-665-02) / 57 g in 1 TUBE1 tube2019-01-010000-00-00NoNoCurrent
70015-665-04700150665041 TUBE in 1 CARTON (70015-665-04) / 113 g in 1 TUBE1 tube2019-01-010000-00-00NoNoCurrent