Bactine Max

Product NDC
65197-832
11-digit product format
651970832
Labeler code
65197
Product ID
65197-832_03328319-d4ca-46ce-9472-df87a3a3b1c8
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
2022-04-01
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
4 g/100mL
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Bactine Max
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
acd7ae37-7c42-4ec7-a2ef-42e7f628388dAvailable on FDA.report

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
65197-832-03Bactine Max10 mL in 1 BOTTLE, GLASSLIQUID104
65197-832-03Bactine Max1 in 1 BOXLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-832BACTINE MAX (LIDOCAINE) LIQUID [WELLSPRING PHARMACEUTICAL CORPORATION]4Current NDC, Legacy NDC, 2 package rows20250110_acd7ae37-7c42-4ec7-a2ef-42e7f628388d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 35 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5 Elementum Delay WipesBENZOCAINE DELAY WIPESMSVenturesGroup O440539b0-612b-3b41-e063-6294a90a1ddd2026-02-05WarningsExact identifier
application number: M017
COOLING PAIN RELIEFMENTHOL, CAMPHORCHEMCO CORPORATION4a156400-7001-d00d-e063-6294a90aa7142026-02-05WarningsExact identifier
application number: M017
burnreliefLIDOCAINE HCLPublix Super Markets, Inc.9660f5e1-d39e-4f86-bf96-dff0f3bb729d2026-02-05Warnings, Adverse reactionsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLPublix Super Markets, Inc.fe442f1e-7045-481a-a501-d629bf568dfb2026-02-05Warnings, Adverse reactionsExact identifier
application number: M017
Care Lix Pain ReliefSALICYLIC ACIDACQUIRED B SCALE LLC65dffffd-ede1-45e2-aa91-bdd5df2df6a62026-02-05WarningsExact identifier
application number: M017
2.5% Menthol PAIN RELIEFMENTHOLNantong Health & Beyond Hygienic Products Inc.8075ba60-772c-4d1a-8584-722bb3e539be2026-02-05WarningsExact identifier
application number: M017
4% Menthol PAIN RELIEFMENTHOLNantong Health & Beyond Hygienic Products Inc.51ce716e-b9f3-4e64-8c8e-17520d40f1922026-02-05WarningsExact identifier
application number: M017
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.2b58058a-f350-4029-b039-117caf1c03732026-02-05WarningsExact identifier
application number: M017
4% MENTHOL COLD THERAPYMENTHOLNantong Health & Beyond Hygienic Products Inc.7acc7282-ef4f-41ec-b51d-a88dfed79bd72026-02-05WarningsExact identifier
application number: M017
Cooling GelPAIN RELIEF COOLING GELNeilMed Pharmaceuticals Inc.49fb637b-ecc5-1f9b-e063-6294a90ab41a2026-02-04WarningsExact identifier
application number: M017
Medicaine Sting and BiteBENZOCAINEDynarex Corporationb721607e-e36b-4691-a824-c8f520bd63862026-02-04WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLCHEMCO CORPORATION4a05f02e-e882-2cb2-e063-6394a90ad3282026-02-04WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4a065965-43bd-e0e3-e063-6294a90ad76a2026-02-04WarningsExact identifier
application number: M017
Menthol plus Camphor Pain ReliefMENTHOL, CAMPHORVeridian Healthcare4a0969d3-1f06-3ba7-e063-6294a90a86272026-02-04WarningsExact identifier
application number: M017
Relief FlexMENTHOLBeone Co., Ltd.49e6f0ef-78fb-26fe-e063-6294a90a66552026-02-03WarningsExact identifier
application number: M017
NATURULZ ULTIMATE HEALINGCAPSAICINI SHAY COSMETICS INC436eac74-d07f-d718-e063-6394a90a86602026-02-03WarningsExact identifier
application number: M017
TheraCare Muscle and Join Pain Relieving CreamMENTHOL, METHYL SALICYLATEVeridian Healthcare18f9829e-c5f9-4253-e063-6394a90a70c62026-02-03WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONECVS PHARMACY, INC8b8cdb26-8e8f-4e95-9d83-d685c90afe012026-02-02WarningsExact identifier
application number: M017
Muscular BalmCAPSAICIN MENTHOL METHYL SALICYLATEEagle Indo Pharma, PT888f88fc-dcaf-93e5-e053-2a95a90a20e12026-02-02WarningsExact identifier
application number: M017
Wang Prom Green Balm by Wang PromWANG PROM WANG PROM GREEN BALM BY VENTURE GO LLCAMBIENCE FAMILY INC4a063898-16a4-695a-e063-6394a90adb932026-02-02WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65197-832-03651970832031 BOTTLE, GLASS in 1 BOX (65197-832-03) / 10 mL in 1 BOTTLE, GLASS2022-04-010000-00-00NoNoCurrent