Biofreeze Ultraflex Plus

Product NDC
59316-898
11-digit product format
593160898
Labeler code
59316
Product ID
59316-898_401e1256-05df-d4a9-e063-6294a90adce4
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
RB Health (US) LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-31
Substance
LIDOCAINE; MENTHOL
Active strength
.04; .01 g/g; g/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Biofreeze Ultraflex Plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE.04 g/g
MENTHOL.01 g/g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59316-898-04Biofreeze Ultraflex Plus4 in 1 CARTONPATCH42
59316-898-04Biofreeze Ultraflex Plus2 g in 1 PATCHPATCH22
59316-898-07Biofreeze Ultraflex Plus2 g in 1 PATCHPATCH22
59316-898-07Biofreeze Ultraflex Plus1 in 1 POUCHPATCH12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59316-898-04593160898044 PATCH in 1 CARTON (59316-898-04) / 2 g in 1 PATCH4 patch2026-01-31NoNoHistorical
59316-898-07593160898071 PATCH in 1 POUCH (59316-898-07) / 2 g in 1 PATCH1 patch2026-01-31NoNoHistorical