FDA.reportPublic FDA data

NDC 61867-101-12 - 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
61867-101-12
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 15 of 171 · 3,401 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OrthoNesic Pain Relieving GelMENTHOL, CAMPHORBlaine Labs Inc.122f60c2-f8df-4625-8bb8-a2244a261b5d2026-07-01WarningsExact identifier
unii: L7T10EIP3A
Desert Harvest RELEVEUMLIDOCAINEDesert Harvest Inc.5d9010ec-d482-44ff-ba27-3bfec5a241c62026-06-30WarningsExact identifier
unii: 98PI200987
PromescentLIDICAINEAbsorption5b508238-3be7-4b0d-bf35-51de79f58f552026-06-30WarningsExact identifier
unii: 98PI200987
Icy Hot Medicated, BackMENTHOLLead Chemical Co., Ltd.03d36a89-d055-4cff-aa9f-f8de25c57f772026-06-30WarningsExact identifier
unii: L7T10EIP3A
Dr.Johnes Lidocaine 4% Topical Analgesic CreamLIDOCAINE HCL,MENTHOLDr.Johnes LLC6144708d-4b0f-4f0d-88e3-6925ba2d004d2026-06-29WarningsExact identifier
unii: 98PI200987
unii: L7T10EIP3A
Pain Relieving Gel-PatchLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.556028b3-06f7-0720-e063-6294a90a2df82026-06-29WarningsExact identifier
unii: 98PI200987
MQ Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.5560cdab-cee8-f6ec-e063-6294a90ad0242026-06-29WarningsExact identifier
unii: 98PI200987
unii: L7T10EIP3A
DISCOUNT DRUG MARTCOUGH DROPS CHERRYDISCOUNT DRUG MART55653790-9400-e63b-e063-6394a90ae5f72026-06-29WarningsExact identifier
unii: L7T10EIP3A
DISCOUNT DRUG MARTCOUGH DROPS MENTHOLDISCOUNT DRUG MART55656a74-9721-62cf-e063-6394a90a7eb72026-06-29WarningsExact identifier
unii: L7T10EIP3A
MGC HealthCOUGH DROPS CHERRYMedical Group Care LLC5565f02b-ce38-339f-e063-6294a90a671c2026-06-29WarningsExact identifier
unii: L7T10EIP3A
Lidocaine 5%LIDOCAINE 5%St. Mary's Medical Park Pharmacy052fa8a3-0e3c-d9c2-e063-6394a90aadd72026-06-29Warnings, Adverse reactionsExact identifier
unii: 98PI200987
LIDOSYNCLIDOCAINE 4%, MENTHOL 1%Ion Pharma, LLC11116755-885e-4cce-bc4c-d87a2baadda42026-06-29WarningsExact identifier
unii: 98PI200987
unii: L7T10EIP3A
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED5553385d-c1e6-1242-e063-6394a90aa5a72026-06-28WarningsExact identifier
unii: 98PI200987
Adellina Lidocaine Numbing Cream Topical Anorectal CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd55260a3e-637a-c53b-e063-6394a90a1b092026-06-27WarningsExact identifier
unii: 98PI200987
HyVee Cough Drops MentholMENTHOLHY-VEE, INC47a6f3c3-a6fa-dd61-e063-6394a90a49652026-06-26WarningsExact identifier
unii: L7T10EIP3A
HyVee Cough Drops CherryMENTHOLHY-VEE, INC47a717e9-56b3-e771-e063-6394a90a5c172026-06-26WarningsExact identifier
unii: L7T10EIP3A
MOROVANLIDOCAINEHONG KONG UNORDERED TRADING CO., LIMITED550c8d2d-e0d7-1531-e063-6394a90a374d2026-06-25WarningsExact identifier
unii: 98PI200987
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: 8CRQ2TH63M
unii: 1VPU26JZZ4
unii: 8SKN0B0MIM
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: L7T10EIP3A
Nervionoix Pro Neuropathy Fast Acting CreamLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporated23abdf62-03a8-4aaa-8e29-0e2585b5ade72026-06-24WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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