NDC 61867-101-11 - 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: 61867-101-11
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 76 of 168 · 3,347 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eyewash Station Additive Concentrate	CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL	Niagara Pharmaceuticals Inc.	362a6b6d-862d-4322-87a8-5b3a07fbe174	2025-11-24	Warnings	Exact identifier unii: 6DC9Q167V3
PUR-WASH	WATER	Niagara Pharmaceuticals Inc.	777e1559-786f-8d54-e053-2991aa0aa98d	2025-11-24	Warnings	Exact identifier unii: 059QF0KO0R
PUR-WASH	WATER	Niagara Pharmaceuticals Inc.	7289103a-5cbf-42f4-8848-e827149a43ca	2025-11-24	Warnings	Exact identifier unii: 059QF0KO0R
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	AMERICANNA WELLNESS, INC.	0d11ab8e-d3ea-c7ef-e063-6294a90ae0a3	2025-11-24	Warnings	Exact identifier unii: L7T10EIP3A
Dragon Pain Relieving	CAMPHOR, MENTHOL	AMERICANNA WELLNESS, INC.	0d113dec-8832-d984-e063-6394a90ae7b3	2025-11-24	Warnings	Exact identifier unii: L7T10EIP3A
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	AMERICANNA WELLNESS, INC.	0d12f03f-dd8b-0be5-e063-6294a90a43db	2025-11-24	Warnings	Exact identifier unii: L7T10EIP3A
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	AMERICANNA WELLNESS, INC.	0d129641-eaea-c3ee-e063-6394a90aa58f	2025-11-24	Warnings	Exact identifier unii: L7T10EIP3A
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	Americanna Wellness, Inc.	002db658-6b1f-ea49-e063-6294a90ae3e7	2025-11-24	Warnings	Exact identifier unii: L7T10EIP3A
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	Americanna Wellness, Inc.	002997d0-3176-3918-e063-6294a90a4408	2025-11-24	Warnings	Exact identifier unii: L7T10EIP3A
Dragon Pain Relieving	CAMPHOR, MENTHOL	AMERICANNA WELLNESS, INC.	0d1059cc-1b0b-4e7b-e063-6294a90a56ea	2025-11-24	Warnings	Exact identifier unii: L7T10EIP3A
GuruNanda Pain Relief	MENTHOL AND CAMPHOR	GURUNANDA, LLC	3ca78342-cc6d-5f6b-e063-6294a90a3f1c	2025-11-24	Warnings	Exact identifier unii: L7T10EIP3A
Dragon Pain Relieving	CAMPHOR, MENTHOL	AMERICANNA WELLNESS, INC.	0d118256-90ee-28ef-e063-6394a90a21e8	2025-11-24	Warnings	Exact identifier unii: L7T10EIP3A
DG 4x Medicated Tooth and Gum Cream	BENZOCAINE	Dollar General	b2c156f0-6d11-1eba-e053-2995a90a6db8	2025-11-21	Warnings	Exact identifier unii: L7T10EIP3A
4x Medicated Toothache and Gum Gel	BENZOCAINE	CVS	a7577d5f-69cf-3f32-e053-2995a90aaba5	2025-11-21	Warnings	Exact identifier unii: L7T10EIP3A
IceQuake Lidocaine Analgesic	LIDOCAINE HYDROCHLORIDE	Dextrum Laboratories, Inc	441daa6f-f273-ac09-e063-6394a90a252c	2025-11-21	Warnings	Exact identifier unii: 98PI200987
Toothache and Gum Relief Cushions	BENZOCAINE	Rite Aid	9970d485-0b78-1438-e053-2995a90ad32c	2025-11-21	Warnings	Exact identifier unii: L7T10EIP3A
Nighttime 4X Medicated Cream	BENZOCAINE	Rite Aid	21645ed1-2dc0-223a-e063-6394a90ab021	2025-11-21	Warnings	Exact identifier unii: L7T10EIP3A
4x Medicated Gum Cream	BENZOCAINE	Albertsons	b81a308c-9c30-0e3d-e053-2a95a90a15d2	2025-11-21	Warnings	Exact identifier unii: L7T10EIP3A
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	b0edd9d9-951f-d3dd-e053-2995a90a8d5a	2025-11-21	Warnings	Exact identifier unii: L7T10EIP3A
Throat Coat Eucalyptus Mint	MENTHOL	Traditional Medicinals, Inc.	a7a86f1b-30e8-6f5d-e053-2a95a90a2a82	2025-11-21	Warnings	Exact identifier unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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