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 24 of 171 · 3,401 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biofreeze Foam	MENTHOL	Reckitt Benckiser LLC	890191e8-99ad-489c-8f21-2592f3d31936	2026-05-13	Warnings	Exact identifier unii: L7T10EIP3A
Lidocaine Pain Relief Patch	LIDOCAINE	GERI-CARE PHARMACEUTICAL CORP	51b7753b-8619-6ea9-e063-6294a90a4ea4	2026-05-13	Warnings	Exact identifier unii: 98PI200987
Valtrum TOPICAL ANALGESIC	CAMPHOR, MENTHOL, METHYL SALICYLATE	Laboratorios Quantium LLC	f3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e	2026-05-13	Warnings	Exact identifier unii: L7T10EIP3A
Systane Pro PF	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f1	2026-05-12	Warnings	Exact identifier unii: 6DC9Q167V3
Biofreeze Professional Colorless	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser	4639201c-a67a-475f-8df6-3dc6225803ad	2026-05-12	Warnings	Exact identifier unii: L7T10EIP3A
Biofreeze Professional Colorless Roll-On	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	bae9946a-4c68-4759-9fb3-0a61a7ad0eb7	2026-05-12	Warnings	Exact identifier unii: L7T10EIP3A
Instaflex Pain Relief Cream	MENTHOL	Healthy Directions, LLC	665b847a-9cfb-49fc-975b-81c97f936575	2026-05-12	Warnings	Exact identifier unii: L7T10EIP3A
Lidocaine anorectal cream	LIDOCAINE 5%	EveryMarket Inc	1604daec-812f-4684-ba98-fbcda07a7461	2026-05-12	Warnings	Exact identifier unii: 98PI200987
Theracare Cold Therapy Pain Relief	MENTHOL	Veridian Healthcare	51a5a043-07b6-1c96-e063-6394a90aa926	2026-05-12	Warnings	Exact identifier unii: L7T10EIP3A
Cepacol Extra Strength Sore Throat cherry	BENZOCAINE AND MENTHOL	Reckitt Benckiser LLC	941e36dd-d8d0-4e5c-8585-10e8f06bf8f0	2026-05-12	Warnings	Exact identifier unii: L7T10EIP3A
Cepacol Extra Strength Sore Throat honey lemon	BENZOCAINE AND MENTHOL	Reckitt Benckiser LLC	d771095b-7de3-48f3-a125-8bc76e7d1778	2026-05-12	Warnings	Exact identifier unii: L7T10EIP3A
Stud 100 Male Genital Desensitizer	LIDOCAINE	Pound International Corp	d075656e-b13f-4a1d-bbb6-501e642698d5	2026-05-12	Warnings	Exact identifier unii: 98PI200987
Cool and Heat	MENTHOL	AMERISOURCE BERGEN	f2bb0e8e-c4cd-0e8c-e053-2995a90a6df7	2026-05-11	Warnings	Exact identifier unii: L7T10EIP3A
Instaflex Extra Strength Pain Relief Cream	MENTHOL, METHYL SALICYLATE	Healthy Directions, LLC	d058c64d-0e4f-45aa-8f52-804961b562e3	2026-05-11	Warnings	Exact identifier unii: L7T10EIP3A
BonicaEaseX Pain Relieving Lidocaine	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	7486fe89-a377-4a37-997d-e3bd16b891a7	2026-05-11	Warnings	Exact identifier unii: 98PI200987
YYSDMVY NUMBING Cream	LIDOCAINE 4% NUMBING CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	5195f5ec-8524-77f5-e063-6294a90abdc2	2026-05-11	Warnings	Exact identifier unii: 98PI200987
Nail- Pflaster	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	519681bc-6312-f627-e063-6394a90a2845	2026-05-11	Warnings	Exact identifier unii: VIF565UC2G
Albertson Lidocaine, Menthol Pain Relief Medicated Patch	LIDOCAINE AND MENTHOL	Safeway	dc647647-90ec-6beb-e053-2a95a90a7982	2026-05-09	Warnings	Exact identifier unii: 98PI200987 unii: L7T10EIP3A
5 Elementum Lidocaine Male Genital Desensitizer	LIDOCAINE MALE GENITAL DESENSITIZER	MSVENTURESGROUP O	514b1738-886e-a95d-e063-6294a90aa707	2026-05-08	Warnings	Exact identifier unii: 98PI200987
Kroger Muscle Rub Cream	MENTHOL, CAMPHOR, METHYL SALICYLATE	Kroger Co.	45c8c79a-b4b4-d4be-e063-6394a90a9251	2026-05-08	Warnings	Exact identifier unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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