FDA.reportPublic FDA data

Extra Strength PreTAT

Manufacturer
Ridge Properties
Effective date
2020-06-19
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 23:08:25

Label at a glance#

ProductExtra Strength PreTAT
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

dosage and administrationdosage and administration

INACTIVE INGREDIENT SECTION

inactive ingredientsinactive ingredients

INDICATIONS & USAGE SECTION

indications and usageindications and usage

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childrenkeep out of reach of children

OTC - ACTIVE INGREDIENT SECTION

active ingredientactive ingredient

OTC - PURPOSE SECTION

purposepurpose

WARNINGS SECTION

warnings sectionwarnings section

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal display panelprincipal display panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010895lidocaine HCl 4 % Topical CreamPSN9
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD9
1010895lidocaine hydrochloride 4 % Topical CreamSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69804-002-022021-07-23C16284748780-19d75b9d0-41ce-f424-e053-dadaa90a57ce16bf62ac-23bb-2577-e054-00144ff88e88
69804-002-032021-07-23C16284748780-19d75b9d0-41ce-f424-e053-dadaa90a57ce16bf62ac-23bb-2577-e054-00144ff88e88
69804-002-052021-07-23C16284748780-19d75b9d0-41ce-f424-e053-dadaa90a57ce16bf62ac-23bb-2577-e054-00144ff88e88
69804-002-022020-02-08C16284748780-19d75b9d0-41ce-f424-e053-dadaa90a57ce16bf62ac-23bb-2577-e054-00144ff88e88
69804-002-032020-02-08C16284748780-19d75b9d0-41ce-f424-e053-dadaa90a57ce16bf62ac-23bb-2577-e054-00144ff88e88
69804-002-052020-02-08C16284748780-19d75b9d0-41ce-f424-e053-dadaa90a57ce16bf62ac-23bb-2577-e054-00144ff88e88
69804-002-022020-01-31C16284748780-19d75b9d0-41ce-f424-e053-dadaa90a57ce16bf62ac-23bb-2577-e054-00144ff88e88
69804-002-032020-01-31C16284748780-19d75b9d0-41ce-f424-e053-dadaa90a57ce16bf62ac-23bb-2577-e054-00144ff88e88
69804-002-052020-01-31C16284748780-19d75b9d0-41ce-f424-e053-dadaa90a57ce16bf62ac-23bb-2577-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69804-002-02Extra Strength PreTAT56700 mg in 1 JARCREAM567009
69804-002-03Extra Strength PreTAT113400 mg in 1 JARCREAM1134009
69804-002-05Extra Strength PreTAT28500 mg in 1 JARCREAM285009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69804-002EXTRA STRENGTH PRETAT (LIDOCAINE HCL) CREAM [RIDGE PROPERTIES]9Legacy NDC, 3 package rows20200429_16bf62ac-23bb-2577-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41A4
LIDOCAINEACTIVE MOIETY98PI2009874
BEHENTRIMONIUM METHOSULFATEINACTIVE INGREDIENT5SHP745C614
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6624
NUTMEG OILINACTIVE INGREDIENTZ1CLM489484
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOF4
WITCH HAZELINACTIVE INGREDIENT101I4J0U344

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69804-00269804-002-02, 69804-002-03, 69804-002-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
AVOCADO OIL6VNO72PFC1IACT
PIPER METHYSTICUM ROOTBOW48C81XPIACT
BENZYL ALCOHOLLKG8494WBHIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
COPAIBA OIL64VX45Y68NIACT
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMERAE7QA6TW0QIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
NUTMEG OILNUTMEG OILZ1CLM48948LIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
2 equally ranked IID candidates
NUTMEG OILNUTMEG OILZ1CLM48948ELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
2 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a4627cbe-9ba2-0cf5-e053-2995a90a7b1416bf62ac-23bb-2577-e054-00144ff88e882020-06-19WarningsExact identifier
spl id: a4627cbe-9ba2-0cf5-e053-2995a90a7b14
spl set id: 16bf62ac-23bb-2577-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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