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 52 of 169 · 3,378 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Release	MENTHOL	Saje Natural Business Inc.	92eec6e7-0367-43c6-bd28-1762390a7114	2026-01-13	Warnings	Exact identifier unii: L7T10EIP3A
Restoral	MENTHOL	Saje Natural Business Inc.	5b6176c1-9ed9-1950-e053-2a91aa0a434e	2026-01-13	Warnings	Exact identifier unii: L7T10EIP3A
Aspercreme with Lidocaine Essential Oils Rosemary Mint	LIDOCAINE	Chattem, Inc.	9c81d5eb-fa9b-47fb-8924-6ebf6a5c6bab	2026-01-13	Warnings	Exact identifier unii: 98PI200987
Capzasin Quick Relief	CAPSAICIN AND MENTHOL	Chattem, Inc.	d6c313a3-8dc6-4231-95b6-ac9399e1c1be	2026-01-13	Warnings	Exact identifier unii: L7T10EIP3A
Lidocaine 5% Patch	LIDOCAINE 5%	Medcore LLC	1afe428f-e223-4ef8-a6ba-968f4cfbf476	2026-01-12	Warnings, Adverse reactions	Exact identifier unii: 98PI200987
Dr Wellskin Numbing Cream	4% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	482f25cc-dee3-c3b6-e063-6294a90a8674	2026-01-12	Warnings	Exact identifier unii: 98PI200987
LONAZEM	MENTHOL,PETROLATUM	PEER PHARM LTD.	91f7a741-4178-4639-9cd5-746a4b9a21bf	2026-01-12	Warnings	Exact identifier unii: L7T10EIP3A
Mineral Ice Pain Relieving	MENTHOL	Crown Laboratories	7b30076a-0af6-2f74-e053-2a91aa0ae08d	2026-01-12	Warnings	Exact identifier unii: L7T10EIP3A
Sarna	PRAMOXINE HYDROCHLORIDE, MENTHOL	Crown Laboratories, Inc	19c41e75-a654-90cf-e063-6394a90a7e97	2026-01-12	Warnings	Exact identifier unii: L7T10EIP3A
BlueStop Max	EXTERNAL ANALGESIC	Clavel Corporation	f1efb51c-5217-4cb2-e053-2a95a90a7f95	2026-01-12	Warnings	Exact identifier unii: L7T10EIP3A
Extra Strength Balm	CAPSICUM AND MENTHOL	Saje Natural Business Inc	f516e416-446b-8f21-e053-2a95a90afd88	2026-01-12	Warnings	Exact identifier unii: L7T10EIP3A
Pain Release	MENTHOL	Saje Natural Business Inc.	3df0e56a-7651-42dc-8ed8-f68836a63c61	2026-01-12	Warnings	Exact identifier unii: L7T10EIP3A
Trauma Less	MENTHOL	Saje Natural Business Inc.	650cba4c-6aba-48c3-9c41-841f19905548	2026-01-12	Warnings	Exact identifier unii: L7T10EIP3A
Chest Comfort	MENTHOL	Saje Natural Business Inc.	8a3db169-6dd7-4dfd-8360-90315288f21b	2026-01-12	Warnings	Exact identifier unii: L7T10EIP3A
Mamisan	LIDOCAINE HYDROCHLORIDE, MENTHOL	Miramar Cosmetics, Inc DBA Miramar Lab	4402e900-c6e9-4f32-8cc4-c84014384a9f	2026-01-12	Warnings	Exact identifier unii: L7T10EIP3A
Curist Lidocaine Patch	LIDOCAINE 4% PATCH	Little Pharma, Inc.	1a8fe44e-7a21-c2ab-e063-6394a90a6100	2026-01-11	Warnings	Exact identifier unii: 98PI200987
CVS Health Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	CVS Pharmacy	022c3083-c611-47d0-aa93-d6c7612e7a47	2026-01-11	Warnings	Exact identifier unii: L7T10EIP3A
CVS Health Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	CVS Pharmacy	bf73d15a-9d68-42fa-bfee-d25748215f97	2026-01-11	Warnings	Exact identifier unii: L7T10EIP3A
Signature numbing cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	4805ba4e-45d3-bf0a-e063-6294a90a6eef	2026-01-10	Warnings	Exact identifier unii: 98PI200987
Lubracane	LUBRACANE	Ozeion LLC	7c503e3e-1987-4027-8a43-12acf2cb548a	2026-01-10	Warnings	Exact identifier unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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