SYLVIRENE NUMBING

Product NDC
85248-163
11-digit product format
852480163
Labeler code
85248
Product ID
85248-163_4d47e8c7-d294-bf63-e063-6294a90a5fd9
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 5% NUMBING
Dosage form
CREAM
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-18
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
SYLVIRENE NUMBING
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui1039690

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-163-01SYLVIRENE NUMBING50 g in 1 BOTTLECREAM501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039690menthol 5 % Topical CreamPSN4d47e8c7-d293-bf63-e063-6294a90a5fd91
1039690menthol 50 MG/ML Topical CreamSCD4d47e8c7-d293-bf63-e063-6294a90a5fd91
1039690menthol 5 % Topical CreamSY4d47e8c7-d293-bf63-e063-6294a90a5fd91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-163-018524801630150 g in 1 BOTTLE (85248-163-01) 50 g2026-03-18NoNoHistorical