FDA.reportPublic FDA data

Painless Tattoo 3

Product NDC
54723-017
11-digit product format
547230017
Labeler code
54723
Product ID
54723-017_436c0c13-b4f8-ee4c-e063-6394a90a6c9f
Type
HUMAN OTC DRUG
Nonproprietary name
Tetracaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Sambria Pharmaceuticals, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-26
Substance
TETRACAINE
Active strength
2 g/100mL
Pharmacologic classes
Ester Local Anesthetic [EPC], Esters [CS], 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
Painless Tattoo 3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRACAINE2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0619F35CGVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1733865Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c24dcff-3988-40eb-821a-fd4b0c85f528Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a26f29b9-6919-4f09-a354-491df8d2b97dProduct name120251021
122d1fa8-7b9e-49b4-89ce-b062ffd1d947Product name120181030
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54723-017-01Painless Tattoo 33 mL in 1 PACKETCREAM35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54723-017PAINLESS TATTOO 3 (TETRACAINE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]3Current NDC, 1 package rows20240510_9c24dcff-3988-40eb-821a-fd4b0c85f528.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 152 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bactine Max Lidocaine Roll-on 2.5ozLIDOCAINEWellSpring Pharmaceutical Corporation09b32a98-9131-451e-87a6-81a1e4ed7ec52023-04-25WarningsExact identifier
application number: M017
Icy Hot Pro DryCAMPHOR, MENTHOLChattem, Inc.4de1bc29-d166-4599-9e75-5f841bf209672023-03-01WarningsExact identifier
application number: M017
Icy Hot Vanishing ScentMENTHOLChattem, Inc.e2092016-9741-433d-92e6-74bfddadb72c2022-09-29WarningsExact identifier
application number: M017
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAlexso, Inc5dbd5fc0-a27e-4979-aca7-28f73096fd5f2022-08-18WarningsExact identifier
application number: M017
FIRSTAR Sting Relief PadBENZOCAINEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.0e491a7a-4204-439f-862d-741cbc0be9fd2021-07-06WarningsExact identifier
application number: M017
Arthritis Relief GoodSenseTROLAMINE SALICYLATEGeiss, Destin & Dunn, Inca253730a-2187-07de-e053-2a95a90a98772020-04-02WarningsExact identifier
application number: M017
Aloe CortHYDROCORTISONETopiderm, Inc.789a6669-3320-4558-8d6f-ab255db50d8d2019-09-17WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited567b6820-fb52-630e-e063-6294a90a8bf82015-07-01WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited54e45d89-e8c3-6fc3-e063-6394a90aac4e2015-06-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1733865tetracaine 2 % Topical CreamPSN9c24dcff-3988-40eb-821a-fd4b0c85f5285
1733865tetracaine 20 MG/ML Topical CreamSCD9c24dcff-3988-40eb-821a-fd4b0c85f5285
1733865tetracaine 2 % Topical CreamSY9c24dcff-3988-40eb-821a-fd4b0c85f5285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54723-017-01547230017013 mL in 1 PACKET (54723-017-01) 3 ml2023-09-26NoNoCurrent