FDA.reportPublic FDA data

Siterol

Product NDC
69440-007
11-digit product format
694400007
Labeler code
69440
Product ID
69440-007_b553bb21-4705-45e1-a49b-336b022680db
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine HCL, Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Binger Consulting Corporation
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength
4 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69440-007IInactivated by FDA2026-10-15
excluded packagepackage69440-00769440-007-15IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69440-007-152021-10-21C16284748780-1c7ccaba7-1605-fd44-e053-dadaa90aa01bSiterol
69440-007-152021-07-23C16284748780-1c7ccaba7-1605-fd44-e053-dadaa90aa01bSiterol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69440-007-15Siterol15 in 1 BOXPATCH155
69440-007-15Siterol100 g in 1 PATCHPATCH1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69440-007-15EA - Each69440-007e623ab55-7f34-4f8c-b64e-a423f79d8dbf12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ASITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
MENTHOL, UNSPECIFIED FORMACTIVE INGREDIENTL7T10EIP3ASITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
LIDOCAINEACTIVE MOIETY98PI200987SITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
MENTHOLACTIVE MOIETYL7T10EIP3ASITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZWSITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
BOSWELLIA SACRA WHOLEINACTIVE INGREDIENT8O600AZL0WSITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV36SITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MSITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSSITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
PEG-8 GLYCERYL ISOSTEARATEINACTIVE INGREDIENT74QQ5X3KL1SITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
TRIETHANOLAMINE BENZOATEINACTIVE INGREDIENTM3EN4GC19WSITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RSITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69440-007SITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]5Legacy NDC, 2 package rows20241129_1ef21407-5fd2-4349-8d4f-af3b13dab476.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373130lidocaine HCl 4 % / menthol 1 % Medicated PatchPSN1ef21407-5fd2-4349-8d4f-af3b13dab4765
1373130lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD1ef21407-5fd2-4349-8d4f-af3b13dab4765
1373130lidocaine HCl 4 % / menthol 1 % Medicated PatchSY1ef21407-5fd2-4349-8d4f-af3b13dab4765

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69440-007-156944000071515 PATCH in 1 BOX (69440-007-15) > 100 g in 1 PATCH15 patch2015-01-010000-00-00NoNoCurrent