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
Label	Manufacturer	Effective date	Type
SOLE SERUM - THE COMFORT LAB LLC	THE COMFORT LAB LLC	2014-06-28	HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61867-101-51	2024-04-01	3d855db4-b10f-474b-88fc-fdade8a8226e
61867-101-52	2024-04-01	3d855db4-b10f-474b-88fc-fdade8a8226e
61867-101-51	2019-11-27	3d855db4-b10f-474b-88fc-fdade8a8226e
61867-101-52	2019-11-27	3d855db4-b10f-474b-88fc-fdade8a8226e

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
LIDOCAINE	ACTIVE MOIETY	98PI200987	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	59TL3WG5CO	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
DIETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	A1A1I8X02B	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
EDETIC ACID	INACTIVE INGREDIENT	9G34HU7RV0	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
Ethylhexyl Palmitate	INACTIVE INGREDIENT	2865993309	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
GLYCERETH-2 COCOATE	INACTIVE INGREDIENT	JWM00VS7HC	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
ISODODECANE	INACTIVE INGREDIENT	A8289P68Y2	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
PEG-8 DIMETHICONE	INACTIVE INGREDIENT	GIA7T764OD	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
TERT-BUTYL METHACRYLATE	INACTIVE INGREDIENT	F9029V5818	SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	SOLE 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 27 of 169 · 3,378 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOMBRA COOL THERAPY	MENTHOL	SOMBRA COSMETICS INC.	87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3	2026-04-21	Warnings	Exact identifier unii: L7T10EIP3A
Careland Lidocaine Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	c4c86a8f-1d57-49d2-a65f-acb0dccf2f87	2026-04-21	Warnings	Exact identifier unii: 98PI200987
Oraqix	LIDOCAINE AND PRILOCAINE	Dentsply Pharmaceutical	b501d239-923b-48b2-82ed-6c5c253a67e2	2026-04-21	Warnings, Adverse reactions	Exact identifier unii: 98PI200987
KT Pain Relief Cream Magnesium with Arnica and 4% Lidocaine	KT PAIN RELIEF CREAM MAGNESIUM WITH ARNICA AND 4% LIDOCAINE ROLLON	Clarion Brands LLC	4f82993c-ebc4-5787-e063-6294a90a12d6	2026-04-20	Warnings	Exact identifier unii: 98PI200987
KT Pain Relief Cream Magnesium with Cooling 5% Menthol	KT PAIN RELIEF CREAM MAGNESIUM WITH COOLING 5% MENTHOL	Clarion Brands LLC	4fe64056-f3c6-bc76-e063-6294a90a7e62	2026-04-20	Warnings	Exact identifier unii: L7T10EIP3A
4x Medicated Toothache and Gum Cream	BENZOCAINE	CVS	a7576238-e7c8-7e86-e053-2995a90aaeb5	2026-04-20	Warnings	Exact identifier unii: L7T10EIP3A
Lidothol ES Patch	LIDOTHOL ES PATCH	Direct_Rx	4fe72fca-9689-fff4-e063-6394a90a3ad2	2026-04-20	Warnings, Adverse reactions	Exact identifier unii: 98PI200987 unii: L7T10EIP3A
Aemerry Numbing Cream	MENTHOL 5%	Da Capo Prima LLC	4fefddaf-19c8-86b4-e063-6294a90abffc	2026-04-20	Warnings	Exact identifier unii: L7T10EIP3A
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Family Dollar (FAMILY WELLNESS)	9f991292-bbaa-4f4e-b2cb-059d1a04849e	2026-04-20	Warnings	Exact identifier unii: L7T10EIP3A
Sting Relief Swab	BENZOCAINE	4 Visions LLC	4fc7a356-2f1d-85af-e063-6394a90aec6b	2026-04-18	Warnings	Exact identifier unii: L7T10EIP3A
Equate Lidocaine and Menthol Paraben Free	LIDOCAINE 4% PLUS MENTHOL 1%	Walmart Stores Inc	4fa917de-bc46-0b8d-e063-6294a90a218a	2026-04-17	Warnings	Exact identifier unii: 98PI200987 unii: L7T10EIP3A
LidoPro	LIDOCAINE AND MENTHOL	Advanced Rx of Tennessee, LLC	4faa515f-6040-d948-e063-6294a90a187f	2026-04-17	Warnings	Exact identifier unii: 98PI200987 unii: L7T10EIP3A
Lidocaine	LIDOCAINE	Macleods Pharmaceuticals Limited	c788afd3-4554-40c4-8f26-2c31ab9b9b98	2026-04-16	Warnings, Adverse reactions	Exact identifier unii: 98PI200987
Ice Gel ICE COLD ANALGESIC	MENTHOL	Universal Distribution Center LLC	4f921ced-7722-cba5-e063-6294a90a650b	2026-04-16	Warnings	Exact identifier unii: L7T10EIP3A
Walgreens Cold Therapy Pain Relieving Patch	MENTHOL	Walgreen Co.	41e7574a-348f-8eb8-e063-6294a90a6e90	2026-04-16	Warnings	Exact identifier unii: L7T10EIP3A
Tartar control plus	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	H E B	e425bc4c-88c7-48ec-98ef-46b45436a689	2026-04-16	Warnings, Adverse reactions	Exact identifier unii: L7T10EIP3A
Stopain Extra Strength Gel	MENTHOL	Troy Manufacturing, Inc.	86fe4e8c-5279-445a-a19a-e694eac785fd	2026-04-16	Warnings	Exact identifier unii: L7T10EIP3A
Stopain Clinical	MENTHOL, UNSPECIFIED FORM	Troy Manufacturing, Inc.	4503208f-2808-4727-8066-c431230bd70b	2026-04-16	Warnings	Exact identifier unii: L7T10EIP3A
EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON	MENTHOL	TROY MANUFACTURING, INC	895896dc-0762-40a7-8313-cca10ce68984	2026-04-16	Warnings	Exact identifier unii: L7T10EIP3A
HealthWise Medicated Cold Hot 5%	MENTHOL	Veridian Healthcare	4f9b1b2d-1acc-e0a7-e063-6394a90aadbc	2026-04-16	Warnings	Exact identifier unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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