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 147 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BLUE SPRING Foot and Leg Comfort MENTHOL ACA MANAGEMENT LLC 5f52218d-eea4-4640-b820-84c077ab98ba 2023-11-06 Warnings Exact identifier application number: M017 EMU THERAPY Red Hot Pepper Pain Relief Cream MENTHOL, CAPSAICIN ACA MANAGEMENT LLC 36293885-b2dd-4fba-9748-35a3c9e05078 2023-11-06 Warnings Exact identifier application number: M017 ROPANA Pain Relief Cream HISTAMINE DIHYDROCHLORIDE FUSION PAIN SOLUTIONS LLC e0342aa3-ca80-40b7-bec6-1b33c4db398b 2023-11-06 Warnings Exact identifier application number: M017 EMU THERAPY Cool Menthol Therapy Pain Relief Cream MENTHOL ACA MANAGEMENT LLC 16894346-3513-41b1-b09f-72d84edcc4ac 2023-11-06 Warnings Exact identifier application number: M017 SKINS DELAY Climax Control Lidocaine LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 0db91010-12f7-4f20-b96c-432915720d5a 2023-11-06 Warnings Exact identifier application number: M017 POWERECT Lidocaine Male Delay LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 42e0c40f-1efd-45ef-815d-53d193d720eb 2023-11-06 Warnings Exact identifier application number: M017 ARTHRO LIFE Instant Pain Relief Cream MENTHOL BIOBEST SERVICES LLC 66eb1a78-6861-4693-b68e-bd4a664fc075 2023-11-06 Warnings Exact identifier application number: M017 PARACTIN QuantumActiv Pain Relief Cream MENTHOL NHR SCIENCE CORP ae2f89cf-120c-4c6f-9e81-4560e6fa0373 2023-11-06 Warnings Exact identifier application number: M017 FISICO Arthrozene Pain Cream MENTHOL FISICO INC. d02c4349-78dd-4672-9582-50124ea9f1e1 2023-11-06 Warnings Exact identifier application number: M017 BRONSON SOOTHE Pain Relief CAPSAICIN BRONSON NUTRITIONALS, LLC cedf8f43-b9a3-4a06-b3a1-cf82668541f8 2023-11-06 Warnings Exact identifier application number: M017 INTIMALE Benzocaine Delay Gel BENZOCAINE SKINS SEXUAL HEALTH LIMITED b845bfd5-ab73-495f-97ef-e959bc6311d9 2023-11-06 Warnings Exact identifier application number: M017 RAPID PAIN-RELIEF TOPICAL LIDOCAINE HYDROCHLORIDE, MENTHOL NORDIC HEALTHY LIVING INC. a06d6aca-9aa2-4bbe-bf77-4c85f1dd7870 2023-11-06 Warnings Exact identifier application number: M017 PURE PERSONAL All Natural Pain Relief Cream MENTHOL PURE PERSONAL CARE, LLC 8f3fb1d0-d238-4b4c-9816-7e335258d71d 2023-11-06 Warnings Exact identifier application number: M017 DIRT Pain Relieving Gel MENTHOL PURIVITAE, LLC 89c80a8f-227d-4ec0-9327-683892e73b6a 2023-11-06 Warnings Exact identifier application number: M017 DIRT Pain Relieving Gel MENTHOL PURIVITAE, LLC e43e2cbd-d114-4b11-8baf-7a775881cd97 2023-11-06 Warnings Exact identifier application number: M017 Celadrin Joint and Muscle Pain Relieving MENTHOL Factors Group of Nutritional Products 6396e4b6-2130-433b-bdb3-97c76dbe685c 2023-11-06 Warnings Exact identifier application number: M017 Atomic Balm METHYL SALICYLATE, CAPSAICIN The Hygenic Company, LLC d10028f3-ae6a-7b01-e053-2995a90a5a84 2023-11-05 Warnings Exact identifier application number: M017 HEMPCIN Advanced Topical Pain Relief Cream MENTHOL Pedicis Research, LLC 97f5e300-b780-4694-a681-60d5e0cfad65 2023-11-05 Warnings Exact identifier application number: M017 Point Relief cold Spot Pain Relieving roll-on MENTHOL Fabrication Enterprises 3f1db0ad-aaa8-4e14-9349-45057e0fb4a6 2023-11-05 Warnings Exact identifier application number: M017 LidoStat LIDOCAINE HCL Clinical Therapeutic Solutions 1825885b-9141-4515-bb69-a1c4a39fb10d 2023-11-05 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