FDA.reportPublic FDA data

DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEF

Product NDC
71884-204
Requested package NDC
71884-204-01
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 54 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burn Ease, 3.5gBURN EASE, 3.5GProStat First Aid LLC004aa18f-3a97-f454-e063-6394a90afcff2025-12-15WarningsExact identifier
application number: M017
PS-3866 Burn Ease, 0.9gPS-3866 BURN EASE, 0.9GProStat First Aid LLC004d00a5-9cff-29ff-e063-6294a90aeb8c2025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLC0037a1a4-d747-2567-e063-6394a90a721c2025-12-15WarningsExact identifier
application number: M017
PS-3885 Burn Ease, 3.5gPS-3885 BURN EASE, 3.5GProStat First Aid LLC004c6deb-2844-a0d0-e063-6394a90ae5e42025-12-15WarningsExact identifier
application number: M017
2677 First Aid Burn Cream2677 FIRST AID BURN CREAMProStat First Aid LLCff5bb628-8ef7-4540-e053-6394a90a55ed2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71b98b4-22d0-0124-e053-6394a90ae4cf2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71eb4f5-2280-5867-e053-6394a90aac572025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8e6842-c889-d5d3-e063-6394a90af8802025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8c59fb-3622-2bb7-e063-6294a90adc6e2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEFront Line Safety0e34cb09-d8c6-f8c0-e063-6294a90a0be02025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f52021f-af8a-5b95-e063-6294a90a2c2a2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLC0e25c936-e40a-e23c-e063-6294a90ac0e42025-12-15WarningsExact identifier
application number: M017
Sting Relief WipesSTING RELIEF WIPESProStat First Aid LLC0e20252a-5ecb-2526-e063-6294a90a8cde2025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMFront Line Safety0f4ce2c2-f306-d95f-e063-6394a90ae7b32025-12-15WarningsExact identifier
application number: M017
Magsoothium BodyMENTHOL, CAPSAICINUbu/Elements, Inc.f604d30c-b17c-ec01-e053-2a95a90aa3042025-12-15WarningsExact identifier
application number: M017
Salonpas pain relieving JETMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.dd1ea3bf-891a-402e-8f43-14302bc9c3e52025-12-15WarningsExact identifier
application number: M017
Herbal Tendon Bone ReliefCAMPHOR MINTGuchutang Biotechnology (Longyan) Co., Ltd.45cf4040-9751-d24b-e063-6294a90aff272025-12-13WarningsExact identifier
application number: M017
ElixirLidoFastLIDOCAINE 5% CREAMELIXIR HEALTHCARE USA, LLC.45de5a3d-06c2-aa02-e063-6294a90a63d32025-12-13WarningsExact identifier
application number: M017
MEDI FIRST PLUSHYDROCORTISONE ACETATEOrazen Inc5781124a-60f4-4a64-80b7-ce5f28d495b52025-12-12WarningsExact identifier
application number: M017
MEDI-FIRSTHYDROCORTISONE ACETATEOrazen Incaeffd85c-58a7-4d64-bf94-977b6fbbe7132025-12-12WarningsExact 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