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 18 of 153 · 3,057 matching rows.
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