REGENECARE HA

Product NDC: 66977-107
11-digit product format: 669770107
Labeler code: 66977
Product ID: 66977-107_4e446d3e-615b-5079-e063-6394a90aca13
Type: HUMAN OTC DRUG
Nonproprietary name: lidocaine HCl
Dosage form: GEL
Route: TOPICAL
Labeler: MPM Medical LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-01-05
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 20 mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 20 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66977-107-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66977-107-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66977-107-03	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66977-107-03	`1332a3947898…`	`d4bfe170f9cd…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	66977-107-25	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	66977-107-03	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	66977-107-25	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	66977-107-03	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	66977-107-25	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	66977-107-03	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	66977-107-25	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	66977-107-03	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: REGENECARE HA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V13007Z41A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1011852	Internal RxNorm lookup
2604879	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c3eec066-38e8-4617-b34d-2f72ffb7a324	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
66977-107-03	2024-07-16	MPM Regenecare HA Gel (MP00107 - 3oz., MPoo108 - 4mL)
66977-107-03	2024-07-16	MPM Regenecare HA Gel (MP00107 - 3oz., MP00108 - 4mL, MP00112 - 0.5oz)
66977-107-03	2024-01-30	MPM Regenecare HA Gel (MP00107 - 3oz., MPoo108 - 4mL)
66977-107-03	2024-01-30	MPM Regenecare HA Gel (MP00107 - 3oz., MP00108 - 4mL, MP00112 - 0.5oz)
66977-107-03	2022-03-08	MPM Regenecare HA Gel (MP00107 - 3oz., MPoo108 - 4mL)
66977-107-03	2022-03-08	MPM Regenecare HA Gel (MP00107 - 3oz., MP00108 - 4mL, MP00112 - 0.5oz)
66977-107-25	2022-03-08	MPM Regenecare HA Gel (MP00107 - 3oz., MPoo108 - 4mL)
66977-107-25	2022-03-08	MPM Regenecare HA Gel (MP00107 - 3oz., MP00108 - 4mL, MP00112 - 0.5oz)
66977-107-03	2019-11-27	MPM Regenecare HA Gel (MP00107 - 3oz., MPoo108 - 4mL)
66977-107-03	2019-11-27	MPM Regenecare HA Gel (MP00107 - 3oz., MP00108 - 4mL, MP00112 - 0.5oz)
66977-107-25	2019-11-27	MPM Regenecare HA Gel (MP00107 - 3oz., MPoo108 - 4mL)
66977-107-25	2019-11-27	MPM Regenecare HA Gel (MP00107 - 3oz., MP00108 - 4mL, MP00112 - 0.5oz)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66977-107-03	REGENECARE HA	85 g in 1 TUBE	GEL	85	8
66977-107-04	REGENECARE HA	4 g in 1 TUBE	GEL	4	8
66977-107-05	REGENECARE HA	14.17 g in 1 TUBE	GEL	14.17	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66977-107-03	GM - Gram	66977-107	0f6fe96d-9a40-449e-b50a-c86e20b35336	1	2013-07-02
66977-107-25	ML - Milliliter	66977-107	eae63e2a-b3b6-4bd0-a32d-dc55d058f221	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]	1
BENZETHONIUM CHLORIDE	INACTIVE INGREDIENT	PH41D05744	REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]	1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66977-107	REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL LLC]	6	Current NDC, Legacy NDC, 3 package rows	20240717_c3eec066-38e8-4617-b34d-2f72ffb7a324.zip

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 68 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PAINGEL UNGUENTO	CAMPHOR, MENTHOL	NACOR BUSINESS GROUP LLC	42fab525-b0a5-97fb-e063-6394a90aec6c	2025-11-06	Warnings	Exact identifier application number: M017
PAINGEL ROLL-ON	MENTHOL	NACOR BUSINESS GROUP LLC	42fb0bdf-8bbd-bbe3-e063-6294a90a656c	2025-11-06	Warnings	Exact identifier application number: M017
Coolexa	CAMPHOR, MENTHOL, METHYL SALICYLATE	Rising Pharma Holdings, Inc.	38839f29-d4ce-4684-a3c7-0bb4bf1ad594	2025-11-06	Warnings	Exact identifier application number: M017
ItchZap	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Rising Pharma Holdings, Inc.	245d0afb-19a8-4cfb-968b-d892b18d5f2c	2025-11-06	Warnings	Exact identifier application number: M017
Pain Relief Gel-Roll On	LIDOCAINE AND MENTHOL	Bullet point LLC	42c70681-494b-47c9-e063-6394a90a80be	2025-11-04	Warnings	Exact identifier application number: M017
China-Gel Topical Pain Reliever	MENTHOL AND CAMOHOR (SYNTHETIC)	China-Gel, LLC	ba6c7e97-d740-484b-8711-55fa7ab15784	2025-11-04	Warnings	Exact identifier application number: M017
China-Gel	MENTHOL AND CAMOHOR (SYNTHETIC)	China-Gel, Inc.	d7c5cb17-f7a2-7f57-e053-2995a90a40f7	2025-11-04	Warnings	Exact identifier application number: M017
Aulief Topical Pain Reliever	MENTHOL AND CAMOHOR	China-Gel, LLC	8647dcc3-1dbc-1093-e053-2991aa0a1ab9	2025-11-04	Warnings	Exact identifier application number: M017
China-Gel Topical Pain Reliever	MENTHOL AND CAMOHOR (SYNTHETIC)	China-Gel, LLC	254abae9-ef1b-5a90-e054-00144ff88e88	2025-11-04	Warnings	Exact identifier application number: M017
Pain Relief Gel-Tube	MENTHOL	Bullet point LLC	42c93789-9758-54b7-e063-6394a90ac398	2025-11-04	Warnings	Exact identifier application number: M017
Tattoo care	TATTOO CARE CREAM	Perfso (HK) Co., Limited	42d0f56f-9cb1-8e19-e063-6394a90aa3e0	2025-11-04	Warnings	Exact identifier application number: M017
CORE RELIEF	CAMPHOR, MENTHOL	Copper Joint, LLC	42d17270-f58d-9d69-e063-6294a90a4078	2025-11-04	Warnings	Exact identifier application number: M017
Lidocaine and Menthol	LIDOCAINE AND MENTHOL	Marcella Health	d25f25ee-79f8-49e7-9715-0aae305b73e5	2025-11-03	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS NO TOUCH SPRAY	Premier Brands of America Inc.	36481d67-2346-470b-e063-6294a90aae99	2025-11-03	Warnings	Exact identifier application number: M017
Lidocaine Numbing Cream	LIDOCAINE 5%	YYBA Corp	1319ee69-8b3f-5815-e063-6294a90a5ad5	2025-11-03	Warnings	Exact identifier application number: M017
Goodsense Extra Strength Cold and Hot Medicated	MENTHOL	Geiss, Destin and Dunn, Inc.	7585d111-775f-4fb6-a485-28cd99d88852	2025-10-31	Warnings	Exact identifier application number: M017
Topcare Cold and Hot Medicated	MENTHOL	Topco Associates LLC	8739aedd-165c-5ae0-e053-2a91aa0afcd0	2025-10-31	Warnings	Exact identifier application number: M017
CVS Medicated Heat 1 ct	CAPSAICIN	CVS Pharmacy, Inc.	d41dce5b-e698-4930-8869-040b2a973f25	2025-10-31	Warnings	Exact identifier application number: M017
Coralite Medicated Heat	CAPSAICIN	United Exchange Corp.	a0b89c7e-80bc-43c4-840c-5fd567f60b21	2025-10-31	Warnings	Exact identifier application number: M017
Dragon with Arnical Pain Relief	MENTHOL	Genomma Lab USA Inc.	b4cbb7b6-cb71-9721-e053-2995a90a2b2c	2025-10-31	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1011852	lidocaine HCl 2 % Topical Gel	PSN	c3eec066-38e8-4617-b34d-2f72ffb7a324	8
2604879	REGENECARE HA 2 % Topical Gel	PSN	c3eec066-38e8-4617-b34d-2f72ffb7a324	8
2604879	lidocaine hydrochloride 0.02 MG/MG Topical Gel [Regenecare]	SBD	c3eec066-38e8-4617-b34d-2f72ffb7a324	8
1011852	lidocaine hydrochloride 0.02 MG/MG Topical Gel	SCD	c3eec066-38e8-4617-b34d-2f72ffb7a324	8
1011852	lidocaine hydrochloride 2 % Topical Jelly	SY	c3eec066-38e8-4617-b34d-2f72ffb7a324	8
2604879	Regenecare 2 % Topical Gel	SY	c3eec066-38e8-4617-b34d-2f72ffb7a324	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66977-107-03	66977010703	85 g in 1 TUBE (66977-107-03)	85 g	2007-01-05	0000-00-00	No	No	Current
66977-107-04	66977010704	4 g in 1 TUBE (66977-107-04)	4 g	2007-01-05		Yes	No	Current
66977-107-05	66977010705	14.17 g in 1 TUBE (66977-107-05)	14.17 g	2007-01-05		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MPM Regenecare HA Gel (MP00107 - 3oz., MP00108 - 4mL, MP00112 - 0.5oz)	MPM Medical LLC	2026-03-30	HUMAN OTC DRUG LABEL	8