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 117 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Odor-Free Therapy Arthritis AnalgesicTROLAMINE SALICYLATEWal-Mart Stores, Inc.1d73e7b6-c7f9-4680-b3e3-a954b91e18632024-11-18WarningsExact identifier
application number: M017
First Aid Only BurnLIDOCAINE HYDROCHLORIDEAcme United Corporation9af39fcd-0a57-26d0-e053-2a95a90a99a02024-11-17WarningsExact identifier
application number: M017
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEAcme United Corporationcaa67a05-bdbd-c380-e053-2995a90a0bf12024-11-17WarningsExact identifier
application number: M017
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafewayc6b9c4e1-bab8-490d-8c00-c43377ad08572024-11-15WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreen Company1a9b8b4c-3e15-49e6-af91-76ed0dc0829e2024-11-15WarningsExact identifier
application number: M017
LidocaineLIDOCAINEPatrin Pharma Inc.91eedf9d-53b8-49d5-af59-25019606a0b22024-11-15WarningsExact identifier
application number: M017
equaline anti itch maximum strengthHYDROCORTISONEUnited Natural Foods, Inc. dba UNFId1ac686e-62f2-4177-8abc-8c7ca578de1a2024-11-15WarningsExact identifier
application number: M017
Meijer Pain Relieving Max Strength with Lavender Essential Oil AnalgesicLIDOCAINE HYDROCHLORIDEMeijer Distribution, Ince688967e-799a-4fc8-a19a-f0012b90e76b2024-11-15WarningsExact identifier
application number: M017
basic care hydrocortisoneHYDROCORTISONEAmazon.com Services LLCa0d0e82b-03ff-4d43-9be0-0e414ee499702024-11-15WarningsExact identifier
application number: M017
DG health hydrocortisoneHYDROCORTISONEDolgencorp, LLC40710bae-32bb-47fd-b3dd-31d2c98ee70f2024-11-15WarningsExact identifier
application number: M017
Meijer Ultra Strength Pain Relieving Topical AnalgesicCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATEMeijer Distribution, Inc6319b019-8e17-4de1-b4e0-b402288a97d42024-11-15WarningsExact identifier
application number: M017
Meijer Pain Relieving analgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMMeijer Distribution, Inc9953be94-5768-448f-83de-f5e53a2972cc2024-11-15WarningsExact identifier
application number: M017
careone anti itchHYDROCORTISONEAmerican Sales Company5f7b1435-ebee-4093-847a-79e8d66414042024-11-15WarningsExact identifier
application number: M017
Tiger BalmMETHYL SALICYLATE AND MENTHOLHaw Par Healthcare Ltd.51293a06-5922-4072-ae14-afaba9c1b58e2024-11-14WarningsExact identifier
application number: M017
Tylenol Precise Warming Pain RelievingLIDOCAINEKenvue Brands LLC0c60b607-ade9-68f2-e063-6394a90a40252024-11-13WarningsExact identifier
application number: M017
Tylenol Precise Pain RelievingLIDOCAINEKenvue Brands LLCfc1e0451-8c84-729e-e053-6394a90aaba02024-11-13WarningsExact identifier
application number: M017
Neosporin Plus Pain Relief First Aid Antibiotic/Pain RelievingNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC23222e54-d793-4d79-980e-550e32a957422024-11-13WarningsExact identifier
application number: M017
TopCare Pain Relieving Roll-On Topical AnalgesicMENTHOL, UNSPECIFIED FORMTopco Associates LLC48589893-ca67-471d-88bc-92014295ab9f2024-11-13WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLCa1c1b878-d58f-41ff-b7a8-477f28c526672024-11-12WarningsExact 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