FDA.reportPublic FDA data

Bactine Max Dry

Product NDC
65197-815
11-digit product format
651970815
Labeler code
65197
Product ID
65197-815_144bf707-6b26-4386-a0ba-0a4a3a797be9
Type
HUMAN OTC DRUG
Nonproprietary name
lidocaine hydrochloride
Dosage form
SPRAY
Route
TOPICAL
Labeler
WellSpring Pharmaceutical Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-31
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

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 Dry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1869797Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
466404cd-c46a-4944-b1ac-3b3b17f436a1Available on FDA.report

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
65197-815-04Bactine Max Dry113 g in 1 CANSPRAY1136

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65197-815-04GM - Gram65197-81561621ba2-fb02-429b-977a-c1a8e3f2179822025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-815BACTINE MAX DRY (LIDOCAINE HYDROCHLORIDE) SPRAY [WELLSPRING PHARMACEUTICAL CORPORATION]6Current NDC, 1 package rows20250110_466404cd-c46a-4944-b1ac-3b3b17f436a1.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 22 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lucys Renewals Skin and Nails First Aid AntisepticBENZETHONIUM CHLORIDEACP Laboratories LLCa702297d-8f7e-4019-a987-7bd83becb5ee2026-05-07WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Sea BreezeALCOHOLScent Theory Products LLC3cfac192-84c8-7897-e063-6294a90ae93d2026-05-06WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Whipped CoconutALCOHOLScent Theory Products LLC3cfaadb3-1881-2dd9-e063-6394a90abcb42026-05-06WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Pink ChampagneALCOHOLScent Theory Products LLC3cf7a910-28c8-bbe2-e063-6394a90aff732026-05-06WarningsExact identifier
application number: M003
Minee Wipes Antibacterial Hand WipeBENZALKONIUM CHLORIDEAmbition Power Brands5132bc70-bf3b-180c-e063-6394a90afdad2026-05-06WarningsExact identifier
application number: M003
Kleenex Reveal Moisturizing Foam Hand SanitizerALCOHOLKimberly-Clark4a491f90-268e-470d-a74c-473f1efe7c8b2026-05-06WarningsExact identifier
application number: M003
Boo Crew Hand Care Essentials Boo Berry, Pumpkin SpiceALCOHOLScent Theory Products LLC51143d5c-4cd0-0b2e-e063-6294a90a28312026-05-05WarningsExact identifier
application number: M003
Scott Moisturizing Foam Hand SanitizerALCOHOLKimberly-Clark25900e62-c8fd-4942-ad38-4b99243084602026-05-05WarningsExact identifier
application number: M003
EVERLIT CARE PRODUCTS ANTISEPTIC MISTHYDROGEN PEROXIDENantong Health & Beyond Hygienic Products Inc.cb97ba55-d678-4e43-aa85-37e9f530e9112026-05-04WarningsExact identifier
application number: M003
EVERLIT CARE PRODUCTS ANTISEPTIC MISTHYDROGEN PEROXIDEEVERLIT GLOBAL INC.4873b106-4ea2-412c-a7ab-756a111959842026-05-04WarningsExact identifier
application number: M003
Limited Edition Hand Sanitizer Golden Vanilla, Starlight Frost, Pink Satin ProseccoALCOHOLScent Theory Products LLC50f03829-eda8-3a25-e063-6294a90a6fd22026-05-03WarningsExact identifier
application number: M003
DUBBLE BUBBLE HAND SANITIZER BUBBLE GUMALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52084e0a-ffe2-83f4-e063-6294a90a305e2026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANI BIRTHDAY CAKEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd520828a5-4e8d-b637-e063-6394a90ab4912026-05-01WarningsExact identifier
application number: M003
ICEE HAND SANI BLUE RASBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52089622-d9b5-b5cb-e063-6394a90ad4262026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208adea-27da-81a3-e063-6294a90afc802026-05-01WarningsExact identifier
application number: M003
ICEE HAND SANI CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52089622-d9b6-b5cb-e063-6394a90ad4262026-05-01WarningsExact identifier
application number: M003
KOOL AID HAND SANITIZER BUBBLE PINK LEMONADEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208bd2c-277c-648e-e063-6294a90a5b282026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANITIZER RAINBOW ICEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52092127-7a8d-5db3-e063-6294a90a07b52026-05-01WarningsExact identifier
application number: M003
Liquid death hand sanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd520943a4-0e63-a9ab-e063-6394a90ab2a92026-05-01WarningsExact identifier
application number: M003
Redicare Antiseptic TowelettesANTISEPTIC TOWELETTESRedicare LLC484c8ff5-cc11-b646-e063-6394a90a5f502026-05-01WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1869797lidocaine 4 % Topical SprayPSN466404cd-c46a-4944-b1ac-3b3b17f436a16
1869797lidocaine 40 MG/ML Topical SpraySCD466404cd-c46a-4944-b1ac-3b3b17f436a16
1869797lidocaine 4 % Topical SpraySY466404cd-c46a-4944-b1ac-3b3b17f436a16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65197-815-0465197081504113 g in 1 CAN (65197-815-04) 113 g2023-01-31NoNoCurrent