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 86 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ULTRA STRENGTH ZHENG GU SHUI	MENTHOL AND CAMPHOR	GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD	53397663-044d-4e48-989b-2c6257af5f84	2025-07-14	Warnings, Adverse reactions	Exact identifier application number: M017
TIGER BALM PAIN RELIEVING HYDROGEL	CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	cb60037f-bceb-4090-a5e4-bdda0cbf9f5c	2025-07-14	Warnings	Exact identifier application number: M017
Avedana Hydrocortisone Cream with Aloe	HYDROCORTISONE	Unipack LLC	2a55c426-39b4-4d94-b6b4-6c548c9685e9	2025-07-13	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE ACETATE	Rite Aid Corporation	cb6e0bed-2ea1-49d2-89e7-2554e7565b74	2025-07-11	Warnings	Exact identifier application number: M017
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll On	LIDOCAINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c4	2025-07-11	Warnings	Exact identifier application number: M017
Antibiotic Plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	TARGET Corporation	6fba5890-f48f-4302-a8ac-5087a6e03bd5	2025-07-11	Warnings	Exact identifier application number: M017
TopCare Antibiotic Plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	55dc4025-f07f-41b2-8b18-6a11ee04b5cc	2025-07-11	Warnings	Exact identifier application number: M017
Benadryl Extra Strength Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Kenvue Brands LLC	309d9be0-e367-429a-a1fa-ab7855477c8a	2025-07-10	Warnings	Exact identifier application number: M017
Bengay Vanishing Scent	MENTHOL, UNSPECIFIED FORM	Kenvue Brands LLC	6cc3294b-3b0f-44d0-af71-61db1022d269	2025-07-10	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	Quality Choice	ce544a7c-8dc6-4e63-b499-d8a4e0ec48c3	2025-07-10	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE ACETATE	Walgreen Company	bff322f1-59c3-41e0-8685-fcfe52bf4b42	2025-07-10	Warnings	Exact identifier application number: M017
CVS Cortisone	HYDROCORTISONE	CVS Pharmacy	87631be8-94b8-4718-858d-d2f30e636cce	2025-07-10	Warnings	Exact identifier application number: M017
TopCare Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	Topco Associates LLC	c40e8e1d-d6d7-4880-99d3-011b97a5e4f3	2025-07-10	Warnings	Exact identifier application number: M017
Live Better Hydrocortisone with Aloe	HYDROCORTISONE	The Great Atlantic & Pacific Tea Company	044e6ee2-98a6-4802-b33d-78b8551356c4	2025-07-10	Warnings	Exact identifier application number: M017
Rocainol TOPICAL ANALGESIC	METHYL SALICYLATE, MENTHOL	Compania Internacional de Comercio, S.A.P.I de C.V.	827ec7b2-3d87-47e0-a47a-966b25732c32	2025-07-10	Warnings	Exact identifier application number: M017
NumbR-X	LIDOCAINE HCL	Prodigy Media Inc	16329ab6-4a33-4c38-85e0-5aad9c75d61d	2025-07-10	Warnings	Exact identifier application number: M017
Dr Lido	LIDOCAINE HCL	Prodigy Media Inc	da0938f0-00e7-4502-8721-d64c71f594fc	2025-07-10	Warnings	Exact identifier application number: M017
Pain Relief Patch	CAMPHOR, METHYL SALICYLATE, MENTHOL	CDMA, Inc.	da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b	2025-07-09	Warnings	Exact identifier application number: M017
ORTHOGEL Menthol 3.5%	MENTHOL	LiquidCapsule Manufacturing LLC	4fd4b7ac-1971-4abe-8fbb-74ab69e12061	2025-07-09	Warnings	Exact identifier application number: M017
Good Neighbor Pharmacy Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	AmerisourceBergen	f36acdb8-a526-4bb7-a557-e1dcbbc1cf45	2025-07-08	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