FDA.reportPublic FDA data

Bactine Max Lidocaine Roll-on 2.5oz

Product NDC
65197-840
11-digit product format
651970840
Labeler code
65197
Product ID
65197-840_119519c2-454f-4d31-8ece-f98e55db1ffd
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
LIQUID
Route
TOPICAL
Labeler
WellSpring Pharmaceutical Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-15
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
4 g/100g
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
Bactine Max Lidocaine Roll-on 2.5oz
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE4 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1987647

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-840-25Bactine Max Lidocaine Roll-on 2.5oz1 in 1 BOXLIQUID12
65197-840-25Bactine Max Lidocaine Roll-on 2.5oz71 g in 1 BOTTLE, PLASTICLIQUID712

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-840BACTINE MAX LIDOCAINE ROLL-ON 2.5OZ (LIDOCAINE) LIQUID [WELLSPRING PHARMACEUTICAL CORPORATION]2Current NDC, 2 package rows20250110_09b32a98-9131-451e-87a6-81a1e4ed7ec5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSN09b32a98-9131-451e-87a6-81a1e4ed7ec52
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCD09b32a98-9131-451e-87a6-81a1e4ed7ec52
1987647lidocaine hydrochloride 4 % Topical SolutionSY09b32a98-9131-451e-87a6-81a1e4ed7ec52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65197-840-25651970840251 BOTTLE, PLASTIC in 1 BOX (65197-840-25) / 71 g in 1 BOTTLE, PLASTIC2024-01-15NoNoCurrent