Home NDC 66977-117 REGENECARE HA
Product NDC 66977-117
11-digit product format 669770117
Labeler code 66977
Product ID 66977-117_47a9559e-2714-c8ff-e063-6294a90ad135
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 2009-06-01
Substance LIDOCAINE HYDROCHLORIDE
Active strength 20 mg/mL
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 · 12 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 2024-05-15 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 66977-117-04 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 66977-117-04 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 66977-117-04 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 66977-117-04 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 66977-117-04 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 66977-117-04 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/mL
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 1010769 Internal RxNorm lookup 1012594 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66977-117-04 REGENECARE HA 120 mL in 1 BOTTLE GEL 120 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 IODOPROPYNYL BUTYLCARBAMATE INACTIVE INGREDIENT 603P14DHEB 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 66977-117 REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL LLC] 3 Current NDC, Legacy NDC, 1 package rows 20240518_0eee554f-dfe0-433a-9665-8bdb95229888.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 133 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dermachange Cold Therapy MENTHOL Private Label Beauty and Wellness 12ef7dd8-3da3-9c87-e063-6394a90ac924 2024-03-05 Warnings Exact identifier application number: M017 Dermachange Arthritis Relief TROLAMIN SALICYLATE Private Beauty Label and Wellness 12dbfa50-1b97-f988-e063-6394a90a662c 2024-03-04 Warnings Exact identifier application number: M017 Analgesic MENTHOL Safetec of America, Inc. b0f4010c-995f-40e1-aa40-92760e697a61 2024-03-02 Warnings Exact identifier application number: M017 Icy Hot Advanced Relief CAMPHOR AND MENTHOL Chattem, Inc. 9979ff36-415b-44e4-bb10-6bf682cd00f9 2024-03-01 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8% MENTHOL Amish Origins Management, LLC 5051b650-18a4-481e-a8d7-d41d4ae51efd 2024-02-29 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE TRIFECTA PHARMACEUTICALS USA LLC 2999fecb-cb15-4023-ade4-ab5822b094d5 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8 MENTHOL Amish Origins Management, LLC aaad56d5-6737-4edc-af0e-8e207695c0ec 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8% MENTHOL Amish Origins Management, LLC b120404f-5a07-4182-bb50-d943418622da 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Topical Analgesic Camphor 2% CAMPHOR (SYNTHETIC) Amish Origins Management, LLC 437491ca-60ff-4508-b408-f97e7152f638 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Topical Analgesic Camphor 2% CAMPHOR (SYNTHETIC) Amish Origins Management, LLC ffe15aed-ea90-4db8-aace-d691a81c05ae 2024-02-29 Warnings Exact identifier application number: M017 LidoPro Patch LIDOCAINE, MENTHOL, AND METHYL SALICYLATE Advanced Rx Pharmacy of Tennessee, LLC 128d0ba9-bc9d-af16-e063-6394a90af5ef 2024-02-29 Warnings Exact identifier application number: M017 Leader Roll-On Cooling Pain Relief Topical Analgesic MENTHOL, UNSPECIFIED FORM Cardinal Health, 110 dba LEADER e86cba40-6b10-454d-98b3-6b547456eaad 2024-02-29 Warnings Exact identifier application number: M017 Maximum Strength Scalp Itch Relief Anti-itch HYDROCORTISONE Rite Aid 55569563-fc38-4f97-8e74-9f96e3173384 2024-02-28 Warnings Exact identifier application number: M017 Walgreens Eczema Relief HYDROCORTISONE ACETATE Walgreen Co. 4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c 2024-02-28 Warnings Exact identifier application number: M017 meijer Cold Therapy Pain Relieving analgesic MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc fb163112-d84d-418d-a410-3214c0ee4b5a 2024-02-28 Warnings Exact identifier application number: M017 SunBurnt PLUS LIDOCAINE HYDROCHLORIDE Quest Products, LLC. 12128c75-015d-8a72-e063-6394a90ae00a 2024-02-23 Warnings Exact identifier application number: M017 Kroger Analgesic Analgesic LIDOCAINE HYDROCHLORIDE THE KROGER CO e6c5ead3-87d0-48ed-a4dc-86cf89ebb285 2024-02-22 Warnings Exact identifier application number: M017 Rugby Pain Relieving Analgesic MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE Bryant Ranch Prepack fcf48536-224e-4a3d-9124-770031823972 2024-02-22 Warnings Exact identifier application number: M017 meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesic MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc 8bc3956b-b82d-4ed3-8bc3-db0078466bbc 2024-02-22 Warnings Exact identifier application number: M017 Promescent Delay Wipes BENZOCAINE Absorption f0a5b6be-acc5-473c-9054-b9534e769db1 2024-02-20 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66977-117-04 66977011704 120 mL in 1 BOTTLE (66977-117-04) 120 ml 2009-06-01 0000-00-00 No No Current