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 54 of 168 · 3,356 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4x Medicated Toothache and Gum CreamBENZOCAINEHEBa71c5259-cbcf-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
unii: L7T10EIP3A
3x Medicated Mouth Sore GelBENZOCAINEHEBa71c5259-cbd1-7566-e053-2995a90a2cb62026-01-08WarningsExact identifier
unii: L7T10EIP3A
4x Medicated Toothache and Gum GelBENZOCAINEPublix Super Markets INC16eb9d15-dba3-36e6-e063-6394a90ab8592026-01-08WarningsExact identifier
unii: L7T10EIP3A
Toothache and Gum ReliefBENZOCAINE, MENTHOLCVS Pharmacy814ec7bf-f825-1095-e053-2a91aa0aee592026-01-08WarningsExact identifier
unii: L7T10EIP3A
DZUL ARTHRITIS PAIN RELIEFMENTHOLCaball Sales, Inc.159c301c-d462-bb2c-e063-6394a90a9e5a2026-01-08WarningsExact identifier
unii: L7T10EIP3A
DZUL - LIDO CREMELIDOCAINE HCL, MENTHOLCaball Sales, Inc.063387e4-a1b1-a467-e063-6294a90a6cbd2026-01-08WarningsExact identifier
unii: L7T10EIP3A
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC49a93cfc-4ccd-4ef3-928f-901b9926f7942026-01-08WarningsExact identifier
unii: 98PI200987
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
TOPICAINELIDOCAINE 4%ESBA LABORATORIES INC.7f96e980-891e-743d-e053-2a91aa0aea5f2026-01-08WarningsExact identifier
unii: 98PI200987
LIPOCAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.849d6e28-a6b8-7f49-e053-2a91aa0a497d2026-01-08WarningsExact identifier
unii: 98PI200987
LUBRICAINELIDOCAINE 4%ESBA LABORATORIES INC.9d7416b1-607d-34e0-e053-2a95a90aa3c32026-01-08WarningsExact identifier
unii: 98PI200987
TOPICAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.15d33ff7-34ed-253d-e054-00144ff88e882026-01-08WarningsExact identifier
unii: 98PI200987
Dr Wellskin Numbing Cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD47ebedc5-caf1-a774-e063-6394a90ae14d2026-01-08WarningsExact identifier
unii: 98PI200987
Organic Acid Combination 9305ORGANIC ACID COMBINATIONProfessional Complementary Health Formulasf2e752c9-2cf1-4511-bf07-5cf422af759c2026-01-08WarningsExact identifier
unii: X045WJ989B
Kidney Stim Liquescence 3013KIDNEY STIM LIQUESCENCEProfessional Complementary Health Formulas7bf81df1-ae1d-476c-9c0f-3821c05acfc72026-01-08WarningsExact identifier
unii: 8SKN0B0MIM
4% MENTHOL COLD THERAPYMENTHOLUniversal Distribution Center LLC66892993-a755-4584-b2a8-2e8d7ac705932026-01-08WarningsExact identifier
unii: L7T10EIP3A
Gout Drops 2080GOUT DROPSProfessional Complementary Health Formulas30696295-01f6-4a50-a932-76fdc7c0501a2026-01-08WarningsExact identifier
unii: 8SKN0B0MIM
Arnica Combination 9208ARNICA COMBINATIONProfessional Complementary Health Formulas1b5fde7b-c5de-48b6-8c10-54efb54ecad32026-01-08WarningsExact identifier
unii: 8SKN0B0MIM
Aesculus Combination 9202AESCULUS COMBINATIONProfessional Complementary Health Formulas5318d83a-2d8f-4ecc-80ac-d191be5f198f2026-01-08WarningsExact identifier
unii: 8SKN0B0MIM

Reported adverse events (FAERS/openFDA)#

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