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 100 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Medicated Pain Relief PatchLIDOCAINESafeway, Inc.2165a342-5f8b-78e0-e063-6394a90a06c42025-02-12WarningsExact identifier
application number: M017
CheeZheng Pain Relieveing PlasterCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd.abcebdf1-9037-4094-93e1-ce8f20b18ea72025-02-11WarningsExact identifier
application number: M017
Tibetree Pain Relieveing Medicated PlasterCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd4216bd48-5c62-4e87-adcc-67bf7152d64d2025-02-11WarningsExact identifier
application number: M017
AsperFlexLIDOCAINEAkron Pharma Inc.ab50525e-b534-452b-8c25-2992c0cbf8622025-02-10WarningsExact identifier
application number: M017
Olu Pain ManagementLIDOCAINE AND CAMPHOROlakino Therapeutics LLC2a41a621-c6f7-5819-e063-6394a90ae67d2025-02-07WarningsExact identifier
application number: M017
Pain Reliveing PatchLIDOCAINE 4%simple diagnostics02ed0b27-bba9-ec0c-e063-6294a90a014d2025-02-07WarningsExact identifier
application number: M017
FlexDermal Pain Relieving Roll-OnMENTHOLSOLVADERM LLCd4d8050e-0761-4491-8635-39c806701eb52025-02-06WarningsExact identifier
application number: M017
Lipo Flavonoid Ear Pain Relief Drops with 4% LidocaineLIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINEClarion Brands LLC2d7e9f6a-0f21-b103-e063-6294a90a912f2025-02-06WarningsExact identifier
application number: M017
signature care HydrocortisoneHYDROCORTISONESafeway9fe16fc5-77e3-47f5-a943-85bc6565c0d42025-02-06WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine SalicylateTROLAMINE SALICYLATETELEBRANDS CORP2d685602-5cd6-3b36-e063-6394a90a3c5d2025-02-05WarningsExact identifier
application number: M017
LidocoreLIDOCAINEiON Pharma, LLC204c3e50-1ac8-f442-e063-6294a90ae7b52025-02-05WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief Cream ExtremeMENTHOL 16%, CAMPHOR 11%Telebrands Corp2d54077e-4c8d-aaae-e063-6394a90adb412025-02-04WarningsExact identifier
application number: M017
Capsaicin External AnalgesicCAPSAICINNuCare Pharmaceuticals,Inc.fd90a67d-d60d-a849-e053-6394a90a2cc82025-02-04WarningsExact identifier
application number: M017
Rugby Muscle Rub CreamMUSCLE RUB CREAMNuCare Pharmaceuticals, Inc.2d58c15a-5ddb-1b16-e063-6294a90a3fbb2025-02-04WarningsExact identifier
application number: M017
CetilarMENTHOL 1.4%PharmaNutra Usa Corp.2dd14bd4-b4e1-bc7d-e063-6394a90a1e592025-02-04WarningsExact identifier
application number: M017
Stopain Extra Strength ContinuousMENTHOLTroy Manufacturing, Inc.0d199d39-5b47-4c7f-b83a-757f39aa17b62025-02-03WarningsExact identifier
application number: M017
TheraCare Pain Relieving Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcare2d42192b-8889-a896-e063-6294a90a4fc82025-02-03WarningsExact identifier
application number: M017
Tiger Balm Pain Relieving MuscleMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.96b06d3f-8685-4314-ad7d-5d2720f4dde62025-02-03WarningsExact identifier
application number: M017
Icy Hot Medicated No Mess ApplicatorMENTHOLChattem, Inc.4ce2b823-7ef5-4cca-a2d8-2fe781bc958e2025-02-01WarningsExact identifier
application number: M017
Cortizone 10 Intensive Healing Itch Relief CreamHYDROCORTISONEChattem, Inc.cdbeb825-3152-4f74-9fd1-93bccfc0e31a2025-02-01WarningsExact 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