External Analgesic Cream with Menthol 5%

Product NDC
85284-010
11-digit product format
852840010
Labeler code
85284
Product ID
85284-010_4b1bbf88-7c2d-e616-e063-6394a90a0864
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 5%
Dosage form
CREAM
Route
TOPICAL
Labeler
BLOOMWELL GARDENS LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-02
Substance
MENTHOL
Active strength
5 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
External Analgesic Cream with Menthol 5%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui1039690

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85284-010-01External Analgesic Cream with Menthol 5%50 g in 1 BOTTLECREAM502

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039690menthol 5 % Topical CreamPSN402faa27-5305-c73d-e063-6394a90a36f22
1039690menthol 50 MG/ML Topical CreamSCD402faa27-5305-c73d-e063-6394a90a36f22
1039690menthol 5 % Topical CreamSY402faa27-5305-c73d-e063-6394a90a36f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85284-010-018528400100150 g in 1 BOTTLE (85284-010-01) 50 g2025-10-02NoNoCurrent