FDA.reportPublic FDA data

BlueStop Max

Product NDC
82714-001
11-digit product format
827140001
Labeler code
82714
Product ID
82714-001_4835cc39-0fd2-f27e-e063-6294a90abf4f
Type
HUMAN OTC DRUG
Nonproprietary name
External Analgesic
Dosage form
GEL
Route
TOPICAL
Labeler
Clavel Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-10
Substance
LIDOCAINE HYDROCHLORIDE; MENTHOL
Active strength
40; 10 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BlueStop Max
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE40 mg/g
MENTHOL10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A, L7T10EIP3A
Rxcui1373137

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82714-001-01BlueStop Max85 g in 1 APPLICATORGEL856
82714-001-01BlueStop Max1 in 1 CARTONGEL16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82714-001BLUESTOP MAX (EXTERNAL ANALGESIC) GEL [CLAVEL CORPORATION]5Current NDC, Legacy NDC, 2 package rows20241208_f1efb51c-5217-4cb2-e053-2a95a90a7f95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373137lidocaine HCl 4 % / menthol 1 % Topical GelPSNf1efb51c-5217-4cb2-e053-2a95a90a7f956
1373137lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCDf1efb51c-5217-4cb2-e053-2a95a90a7f956
1373137lidocaine hydrochloride 4 % / menthol 1 % Topical GelSYf1efb51c-5217-4cb2-e053-2a95a90a7f956

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82714-001-01827140001011 APPLICATOR in 1 CARTON (82714-001-01) / 85 g in 1 APPLICATOR1 applicator2023-01-100000-00-00NoNoCurrent