FDA.reportPublic FDA data

Bactine Max Antibiotic and Lidocaine Max Pain Relief

Product NDC
65197-827
11-digit product format
651970827
Labeler code
65197
Product ID
65197-827_4b43197b-b1f7-44b3-a750-7b10c685fa9a
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
WellSpring Pharmaceutical Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-15
Substance
BACITRACIN ZINC; LIDOCAINE HYDROCHLORIDE; POLYMYXIN B SULFATE
Active strength
500; .04; 10000 U/g; g/g; U/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Decreased Cell Wall Synthesis & Repair [PE], Local Anesthesia [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
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 Antibiotic and Lidocaine Max Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 U/g
LIDOCAINE HYDROCHLORIDE.04 g/g
POLYMYXIN B SULFATE10000 U/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, V13007Z41A, 19371312D4

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
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
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
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-827-05Bactine Max Antibiotic and Lidocaine Max Pain Relief14.2 g in 1 TUBEOINTMENT14.23
65197-827-05Bactine Max Antibiotic and Lidocaine Max Pain Relief1 in 1 BOXOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-827BACTINE MAX ANTIBIOTIC AND LIDOCAINE MAX PAIN RELIEF (LIDOCAINE) OINTMENT [WELLSPRING PHARMACEUTICAL CORPORATION]3Current NDC, 2 package rows20250110_71300df9-6113-4f25-93ca-28ad7e7f79de.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65197-827-05651970827051 TUBE in 1 BOX (65197-827-05) / 14.2 g in 1 TUBE1 tube2024-01-15NoNoHistorical