FDA.reportPublic FDA data

DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEF

Product NDC
71884-204
11-digit product format
718840204
Labeler code
71884
Product ID
71884-204_09dd7a4a-1a4a-4237-b72c-6ed735c73c36
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride, Lidocaine
Dosage form
GEL
Route
TOPICAL
Labeler
Enviro Specialty Chemicals Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-01
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE
Active strength
1.3; 40 mg/mL; mg/mL
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

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
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL
LIDOCAINE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2629979Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7abe66c-dc2d-4ef7-9b11-5b87157fd302Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71884-204-01DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEF30 mL in 1 TUBEGEL302
71884-204-02DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEF59 mL in 1 TUBEGEL592
71884-204-03DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEF118 mL in 1 TUBEGEL1182
71884-204-04DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEF237 mL in 1 TUBEGEL2372
71884-204-05DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEF3785 mL in 1 JUGGEL37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71884-204DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEF (BENZALKONIUM CHLORIDE, LIDOCAINE) GEL [ENVIRO SPECIALTY CHEMICALS INC]2Current NDC, 5 package rows20250106_f7abe66c-dc2d-4ef7-9b11-5b87157fd302.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 114 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medicaine Sting and BiteBENZOCAINEJames Alexander Corporation753e6cbe-31e0-4017-93d0-8b4bf5972f372024-12-09WarningsExact identifier
application number: M017
AUVON Pain Relief Roll-onMENTHOLSHENZHEN YUWEN E-COMMERCE CO., LTD.df239c4d-af6a-41ca-baed-d0788782ce9f2024-12-08WarningsExact identifier
application number: M017
AUVON Pain Relief Roll-onLIDOCAINESHENZHEN YUWEN E-COMMERCE CO., LTD.8b30f623-6077-4f2e-8fa4-ce4a298953b52024-12-08WarningsExact identifier
application number: M017
QC Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLChain Drug Marketing Associationb5e41e3a-81df-3a63-e053-2a95a90a58392024-12-08WarningsExact identifier
application number: M017
QC Lidocaine Maximum StrengthLIDOCAINE HCLChain Drug Marketing Associationb5e1b1ab-8a95-2d2d-e053-2995a90aea532024-12-08WarningsExact identifier
application number: M017
CapsaicinCAPSAICINAlexso, Inc433da27d-04fb-481a-bbb0-874bb72c806a2024-12-06WarningsExact identifier
application number: M017
POMG PAIN RELIEF BODYLIDOCAINEPOMG LLC28d7ac46-b27f-43bb-e063-6294a90a93ed2024-12-06WarningsExact identifier
application number: M017
Capsaicin 0.1 PercentCAPSAICINAlexso, Inc0090ca38-6433-45c4-9453-edf2788c14c62024-12-06WarningsExact identifier
application number: M017
Signature Care MentholMENTHOL 4%Safeway27d3cb47-a6c7-5b7a-e063-6394a90a056f2024-12-05WarningsExact identifier
application number: M017
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
application number: M017
PO First Aid Series BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.f1c349a8-216d-4233-922e-c95329a33d1e2024-12-05WarningsExact identifier
application number: M017
Post Treatment BalmHYDROCORTISONEAllure Labs Inc.faa803e6-453c-4d86-85dd-5a5dcdd72d022024-12-05WarningsExact identifier
application number: M017
CBD Pain Relief CreamTROLAMINE SALICYLATEAllure Labsb6b3102a-4154-2da2-e053-2995a90ae99f2024-12-05WarningsExact identifier
application number: M017
CVS Health Pain RelievingCAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATENatural Essentials, Inc.f7198485-3d68-41d2-b9b9-f932a06493102024-12-04WarningsExact identifier
application number: M017
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
application number: M017
Bite and ItchDIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEWeeks & Leo Co., Inc.0a4d471b-c3f3-0a6a-e063-6394a90ad57b2024-12-03WarningsExact identifier
application number: M017
MentholAMISH ORIGINS MEDICATEDAmish Origins LLC547abe39-3af3-4d70-99dd-caf8d67feda22024-12-03WarningsExact identifier
application number: M017
Meijer Small Cold-Hot Medicated PatchesMENTHOLMeijer Distribution Incbe6012d6-2062-45ba-8fc4-abf14cff58452024-12-03WarningsExact identifier
application number: M017
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.acdd5622-a9a7-4cc3-877e-57efea23303f2024-12-03WarningsExact identifier
application number: M017
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff52024-12-03WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2629979benzalkonium chloride 0.13 % / lidocaine 4 % Topical GelPSNf7abe66c-dc2d-4ef7-9b11-5b87157fd3022
2629979benzalkonium chloride 0.0013 MG/MG / lidocaine 0.04 MG/MG Topical GelSCDf7abe66c-dc2d-4ef7-9b11-5b87157fd3022
2629979benzalkonium chloride 0.13 % / lidocaine 4 % Topical GelSYf7abe66c-dc2d-4ef7-9b11-5b87157fd3022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71884-204-017188402040130 mL in 1 TUBE (71884-204-01) 30 ml2022-09-01NoNoCurrent
71884-204-027188402040259 mL in 1 TUBE (71884-204-02) 59 ml2022-09-01NoNoCurrent
71884-204-0371884020403118 mL in 1 TUBE (71884-204-03) 118 ml2022-09-01NoNoCurrent
71884-204-0471884020404237 mL in 1 TUBE (71884-204-04) 237 ml2022-09-01NoNoCurrent
71884-204-05718840204053785 mL in 1 JUG (71884-204-05) 3785 ml2022-09-01NoNoCurrent