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#

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 32 of 169 · 3,378 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MGC HealthCOUGH DROPS HONEY SUGAR-FREEMedical Group Care LLCf4a9ba87-c2a1-2de0-e053-2a95a90ada4c2026-03-25WarningsExact identifier
unii: L7T10EIP3A
MGC HealthCOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f3f6dd-751d-1dfe-e063-6394a90a0dbb2026-03-25WarningsExact identifier
unii: L7T10EIP3A
MGC HealthCOUGH DROPS MENTHOL SUGAR-FREEMedical Group Care LLCf4a90af2-47af-ac8c-e053-2a95a90ab97e2026-03-25WarningsExact identifier
unii: L7T10EIP3A
MGC HealthCOUGH DROPS BLACK CHERRY SUGAR FREEMedical Group Care LLC043b3639-ab38-adff-e063-6394a90a2ade2026-03-25WarningsExact identifier
unii: L7T10EIP3A
EjaGuardLIDOCAINEMOLANSPACE INC475f64ef-d636-7e87-e063-6294a90ae32f2026-03-25WarningsExact identifier
unii: 98PI200987
Lidocaine 5%LIDOCAINE 5%YARAL Pharma Inc.fc495fc8-15d6-27c7-e053-6394a90ab30d2026-03-24Warnings, Adverse reactionsExact identifier
unii: 98PI200987
Hemorrhoid Relief CreamLIDOCAINE 5% ANORECTALALAINA HEALTHCARE PRIVATE LIMITED53b2c3b0-d729-44d6-bc64-a9e1c93518772026-03-23WarningsExact identifier
unii: 98PI200987
Throat Comfort Orange Mint Cinnamon DropsMENTHOLRicola Ag27487e5c-044c-41eb-865f-2f34351afd522026-03-23WarningsExact identifier
unii: L7T10EIP3A
Throat Comfort Lemon Mint Ginger DropsMENTHOLRicola Agd63b4d24-e926-418c-bb17-420aeaad5a622026-03-23WarningsExact identifier
unii: L7T10EIP3A
Throat Comfort Lemon Mint Ginger DropsMENTHOLRicola USA Inc.5d7889b1-3866-49b0-97e1-1e883a52d3cb2026-03-23WarningsExact identifier
unii: L7T10EIP3A
Throat Comfort Orange Mint Cinnamon DropsMENTHOLRicola USA Inc.1487652c-dbc1-40f4-9d59-891ec74cc3632026-03-23WarningsExact identifier
unii: L7T10EIP3A
DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ONALIVIO TOTAL ROLL ONEVI LABS4da01338-8739-08a8-e063-6294a90ae1572026-03-22WarningsExact identifier
unii: L7T10EIP3A
DR SANA ALIVIO TOTAL ALIVIO TOTALALIVIO TOTALEVI LABS4da1c3b8-9af2-6e9f-e063-6394a90a86ae2026-03-22WarningsExact identifier
unii: L7T10EIP3A
Topical Hemorrhoid Relief GelMENTHOL, UNSPECIFIED FORMYantai Aien Biotechnology Co., Ltd.4d6e6667-ab1c-de7c-e063-6294a90a0b9b2026-03-20WarningsExact identifier
unii: L7T10EIP3A
SORE NO MOREMENTHOL CAMPHORSOMBRA COSMETICS INC.80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd2026-03-20WarningsExact identifier
unii: L7T10EIP3A
ANIXIKE NumbingMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d5c52d7-8e81-b62f-e063-6394a90ad03e2026-03-19WarningsExact identifier
unii: L7T10EIP3A
SmileCare Mouth Ulcer GelMENTHOLYantai Aien Biotechnology Co., Ltd.4d6db039-5b97-8f3f-e063-6294a90a9d852026-03-19WarningsExact identifier
unii: L7T10EIP3A
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SYLVIRENE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d47e8c7-d293-bf63-e063-6294a90a5fd92026-03-18WarningsExact identifier
unii: L7T10EIP3A
Harris Teeter Menthol Cough DropsMENTHOLHarris Teeter4d502c1f-7307-ac50-e063-6294a90a6ff42026-03-18WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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