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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66977-107-03557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66977-107-038af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66977-107-03834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66977-107-031332a3947898…d4bfe170f9cd…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66977-107-258dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66977-107-038dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66977-107-25e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66977-107-03e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66977-107-259bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66977-107-039bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66977-107-25110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66977-107-03110d247fa046…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
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c3eec066-38e8-4617-b34d-2f72ffb7a324Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66977-107-03REGENECARE HA85 g in 1 TUBEGEL858
66977-107-04REGENECARE HA4 g in 1 TUBEGEL48
66977-107-05REGENECARE HA14.17 g in 1 TUBEGEL14.178

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66977-107-03GM - Gram66977-1070f6fe96d-9a40-449e-b50a-c86e20b3533612013-07-02
66977-107-25ML - Milliliter66977-107eae63e2a-b3b6-4bd0-a32d-dc55d058f22112013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41AREGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XREGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]1
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EREGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXREGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THREGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKREGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RREGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66977-107REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL LLC]6Current NDC, Legacy NDC, 3 package rows20240717_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 22 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited06cb845c-cc53-1f1d-e063-6394a90a8c012026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0ef7c3aa-94a3-9fe9-e063-6394a90ab13d2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5071f145-49f7-0855-e063-6394a90a8f262026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09260c31-56a3-07aa-e063-6394a90a95fd2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5072ad57-9fa7-ddba-e063-6394a90a319b2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09235f26-2262-6ca2-e063-6394a90ad8f12026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0f333f93-bec6-72d5-e063-6394a90a4e3f2026-04-27WarningsExact identifier
application number: M017
HIP PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.502f1f9e-8552-ca7b-e063-6394a90a7c532026-04-24WarningsExact identifier
application number: M017
SOMBRA WARM THERAPYMENTHOL CAMPHORSOMBRA COSMETICS INC.de78dba9-53b3-4dbd-9dd2-6a692378da342026-04-24WarningsExact identifier
application number: M017
Rite Aid Itch ReliefDIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%Rite Aide285df43-317c-d862-e053-2a95a90acdce2026-04-23WarningsExact identifier
application number: M017
FixMySkin Healing Balm UnflavoredHYDROCORTISONELovely Skin, Inc.9ff8db07-ad6d-4865-a534-94bd8312957e2026-04-23WarningsExact identifier
application number: M017
DCH Labs CortisoneHYDROCORTISONE 1%Derma Care Research Labs5025f53a-02e0-0f6a-e063-6394a90adbbf2026-04-23WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEPreferred Pharmaceuticals Inc.e0f46445-64c5-4f5d-90b0-3fa07ed7d1b42026-04-22WarningsExact identifier
application number: M017
Dr. Carrasco Pain ReliefMENTHOLCarrasco Enterprises, Inc.befa8526-f468-428e-a829-422c2ea486122026-04-21WarningsExact identifier
application number: M017
HealthWise Feminine Anti-itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare4ff88b9e-5869-a1cb-e063-6294a90a87b72026-04-21WarningsExact identifier
application number: M017
SOMBRA COOL THERAPYMENTHOLSOMBRA COSMETICS INC.87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca32026-04-21WarningsExact identifier
application number: M017
Careland Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.c4c86a8f-1d57-49d2-a65f-acb0dccf2f872026-04-21WarningsExact identifier
application number: M017
KOXUO Arnica Bruise CreamARNICA BRUISE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5003bf83-fa01-b01a-e063-6294a90ad37f2026-04-21WarningsExact identifier
application number: M017
KT Pain Relief Cream Magnesium with Arnica and 4% LidocaineKT PAIN RELIEF CREAM MAGNESIUM WITH ARNICA AND 4% LIDOCAINE ROLLONClarion Brands LLC4f82993c-ebc4-5787-e063-6294a90a12d62026-04-20WarningsExact identifier
application number: M017
KT Pain Relief Cream Magnesium with Cooling 5% MentholKT PAIN RELIEF CREAM MAGNESIUM WITH COOLING 5% MENTHOLClarion Brands LLC4fe64056-f3c6-bc76-e063-6294a90a7e622026-04-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSNc3eec066-38e8-4617-b34d-2f72ffb7a3248
2604879REGENECARE HA 2 % Topical GelPSNc3eec066-38e8-4617-b34d-2f72ffb7a3248
2604879lidocaine hydrochloride 0.02 MG/MG Topical Gel [Regenecare]SBDc3eec066-38e8-4617-b34d-2f72ffb7a3248
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCDc3eec066-38e8-4617-b34d-2f72ffb7a3248
1011852lidocaine hydrochloride 2 % Topical JellySYc3eec066-38e8-4617-b34d-2f72ffb7a3248
2604879Regenecare 2 % Topical GelSYc3eec066-38e8-4617-b34d-2f72ffb7a3248

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66977-107-036697701070385 g in 1 TUBE (66977-107-03) 85 g2007-01-050000-00-00NoNoCurrent
66977-107-04669770107044 g in 1 TUBE (66977-107-04) 4 g2007-01-05YesNoCurrent
66977-107-056697701070514.17 g in 1 TUBE (66977-107-05) 14.17 g2007-01-05NoNoCurrent