FDA.reportPublic FDA data

NDC 61867-101-11 - SOLE SERUM

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
61867-101
Requested NDC
61867-101-11
Package NDCs from labels
61867-101-11, 61867-101-51, 61867-101-12, 61867-101-52
Manufacturer
THE COMFORT LAB LLC
Effective date
2014-06-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SOLE SERUM - THE COMFORT LAB LLCTHE COMFORT LAB LLC2014-06-28HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61867-101-512024-04-013d855db4-b10f-474b-88fc-fdade8a8226e
61867-101-522024-04-013d855db4-b10f-474b-88fc-fdade8a8226e
61867-101-512019-11-273d855db4-b10f-474b-88fc-fdade8a8226e
61867-101-522019-11-273d855db4-b10f-474b-88fc-fdade8a8226e

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
LIDOCAINEACTIVE MOIETY98PI200987SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02BSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV0SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
Ethylhexyl PalmitateINACTIVE INGREDIENT2865993309SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
GLYCERETH-2 COCOATEINACTIVE INGREDIENTJWM00VS7HCSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
ISODODECANEINACTIVE INGREDIENTA8289P68Y2SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
MENTHOLINACTIVE INGREDIENTL7T10EIP3ASOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
PEG-8 DIMETHICONEINACTIVE INGREDIENTGIA7T764ODSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UTSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
TERT-BUTYL METHACRYLATEINACTIVE INGREDIENTF9029V5818SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RSOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]3

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 47 of 169 · 3,378 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength BalmCAPSICUM, MENTHOLNATURES FORMULAE HEALTH PRODUCTS LTD.498a5e2a-4de0-561c-e063-6394a90ac05c2026-01-29WarningsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL7-Eleven5625ac4e-aa37-41b5-80b7-67b223707ccf2026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET POTENT PAIN RELIEF45c76956-db3f-3e84-e063-6394a90adce12026-01-29WarningsExact identifier
unii: L7T10EIP3A
PAIN RELIEF PATCHESLIDOCAINEWALMART STORES INCb82cfe42-f521-4784-8c60-98481524c5ec2026-01-29WarningsExact identifier
unii: 98PI200987
Equate Pain Relief Patch Camphor/Menthol/SalicylateCAMPHOR, MENTHOL, METHYL SALICYLATEWalmart Stores Incb869848c-21e2-5ca2-e053-2995a90a86f22026-01-29WarningsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLAldi, Inc08aef3fa-f863-4716-ac72-1d7bfcc0d6ef2026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INC498cd2aa-ee59-67b5-e063-6294a90ac2422026-01-29WarningsExact identifier
unii: L7T10EIP3A
COOLING PAIN RELIEFMENTHOL, CAMPHORSUNSET NOVELTIES, INC498d76d8-788b-4cc7-e063-6294a90a16962026-01-29WarningsExact identifier
unii: L7T10EIP3A
Eucalyptol, Menthol, Methyl Salicylate, ThymolEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLAMERISOURCE BERGEN02ffe892-732b-4798-9ea8-ca646c37f3002026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLBelmora LLC3622e072-2784-c57e-e063-6394a90a82172026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCardinal Health, 110 dba Leaderd176eebb-4870-4206-a52e-f581ecaff4002026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCariba International4ca91b34-a3ba-4c23-8bfb-473342ac42a22026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCariba International98471185-3798-412f-b9b4-47f1971fbc7c2026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLCariba International035e82fc-75eb-474d-88ce-771e60e621792026-01-29Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
MQUPIN Lidocaine Gel-PatchLIDOCAINE GEL-PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.49703717-69a6-e480-e063-6394a90ac69c2026-01-28WarningsExact identifier
unii: 98PI200987
unii: L7T10EIP3A
MQXUNMI LIDOCAINE Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.49706db7-bacd-190f-e063-6394a90a3a8e2026-01-28WarningsExact identifier
unii: 98PI200987
unii: L7T10EIP3A
Joint and Muscle Relief Topical AnalgesicMENTHOLSmart Cookie Solutions1ecf56b1-ffcb-486f-9fdd-d4dc92aefc1d2026-01-28WarningsExact identifier
unii: L7T10EIP3A
LUBRICAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.9d98afbf-11ce-745b-e053-2a95a90abc142026-01-28WarningsExact identifier
unii: 98PI200987
Lidocaine Pain Relief Gel PatchLIDOCAINE PAIN RELIEFDynarex960e4240-cd09-2560-e053-2a95a90a7bcf2026-01-28WarningsExact identifier
unii: 98PI200987
Lidocaine and PrilocaineLIDOCAINE AND PRILOCAINEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC833cd52c-6470-49c4-937f-1393971f4db92026-01-28Warnings, Adverse reactionsExact identifier
unii: 98PI200987

Reported adverse events (FAERS/openFDA)#

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