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 83 of 168 · 3,347 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aromalief Pain Relief Cream Orange Ginger	MENTHOL	Marketites LLC	9e8d3611-ef1b-4ac6-e053-2995a90af28a	2025-10-29	Warnings	Exact identifier unii: L7T10EIP3A
Aromalief Calming Pain Relief Cream Lavender	MENTHOL	Marketites LLC	b8197d52-ccfb-b008-e053-2995a90a0a53	2025-10-29	Warnings	Exact identifier unii: L7T10EIP3A
Aromalief Cozy Vanilla Pain Relief Cream	MENTHOL	Marketites LLC	3634e55e-8c62-a782-e063-6394a90a6508	2025-10-29	Warnings	Exact identifier unii: L7T10EIP3A
Workvie	LIDOCAINE HCL, MENTHOL	Marketites LLC	aebaffb5-58dd-ebd5-e053-2a95a90a14ed	2025-10-29	Warnings	Exact identifier unii: L7T10EIP3A
BENOVA PAIN AND ITCH RELIEF	MENTHOL, 0.11%	BENOVA RX LLC	42513ee2-8b40-a9f3-e063-6394a90a9386	2025-10-29	Warnings	Exact identifier unii: L7T10EIP3A
Burn Relief	LIDOCAINE	CVS Pharmacy	7e9285fd-26d5-3eac-e053-2991aa0ae2db	2025-10-29	Warnings	Exact identifier unii: 98PI200987
Coralite Ultra Strength Pain Relief	CAMPHOR MENTHOL	United Exchange Corp.	44ecf959-cc07-4adc-a500-075b2ee69548	2025-10-29	Warnings	Exact identifier unii: L7T10EIP3A
Sterile Water	WATER	ICU Medical Inc.	1c0bbcb7-5ed6-4ee7-b297-080d3359474e	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
GoodSense Pain Relief	LIDOCAINE	Geiss, Destin & Dunn, Inc	826f8da4-8468-ea0a-e053-2991aa0a66cb	2025-10-28	Warnings	Exact identifier unii: 98PI200987
CALMADOL	CAMPHOR, MENTHOL, METHYL SALICYLATE	GRANDALL DISTRIBUTING, LLC	31b7f84e-8b66-4d31-8e9c-279d0af2fe64	2025-10-28	Warnings	Exact identifier unii: L7T10EIP3A
XRay DOL	CAMPHOR, MENTHOL, AND METHYL SALICYLATE	Genomma Lab USA, Inc.	e07fef46-68d9-769c-e053-2a95a90aa065	2025-10-28	Warnings	Exact identifier unii: L7T10EIP3A
Foster and Thrive	LIDOCAINE	STRATEGIC SOURCING SERVICES, LLC	f950b072-d978-b629-e053-6394a90abfaf	2025-10-28	Warnings	Exact identifier unii: 98PI200987
lidocaine	LIDOCAINE	PHOENIX RX LLC	3a602aee-09e2-892c-e063-6294a90a558f	2025-10-28	Warnings, Adverse reactions	Exact identifier unii: 98PI200987
Bacteriostatic Water	WATER	Henry Schein, Inc.	a833502e-a622-4e81-8c58-cef6ccb6c4c9	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
PR	MENTHOL	Amphp, Inc	6f5b9e08-c445-4fac-e053-2a91aa0aa737	2025-10-27	Warnings	Exact identifier unii: L7T10EIP3A
Lidocaine	BURN RELIEF	Foodhold USA	b25dc0df-02d0-41ac-b36c-2c04baa77ef2	2025-10-27	Warnings	Exact identifier unii: 98PI200987
Menthol	MAXIMUM STRENGTH MEDICATED FOOT POWDER TALC FREE	FSA Store Inc.	fb3548c8-f202-dc50-e053-6394a90a5b30	2025-10-27	Warnings	Exact identifier unii: L7T10EIP3A
Cough Drops Dollar General Strawberry 30ct	MENTHOL	Dollar General Corporation	7d2f3292-bb73-41dc-9729-edb83670be1b	2025-10-24	Warnings	Exact identifier unii: L7T10EIP3A
Freegells Cough Drops Menthol 30ct	MENTHOL	R.L. ALBERT & SON, INC	b174e57c-4e4f-4842-b8f2-f1b067764a68	2025-10-24	Warnings	Exact identifier unii: L7T10EIP3A
Extra Strength	MENTHOL AND METHYL SALICYLATE	Saje Natural Business Inc.	87d872b3-3231-d0f2-e053-2995a90a9d98	2025-10-24	Warnings	Exact identifier unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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