FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66977-117-04834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66977-117-041332a3947898…d4bfe170f9cd…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66977-117-048dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66977-117-04e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66977-117-049bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66977-117-04110d247fa046…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/mL

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
1010769Internal RxNorm lookup
1012594Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0eee554f-dfe0-433a-9665-8bdb95229888Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-05-17MP00117 MPM Regenecare HA Spray 4 fl.oz.
2024-01-30MP00117 MPM Regenecare HA Spray 4 fl.oz.
2022-03-16MP00117 MPM Regenecare HA Spray 4 fl.oz.
2019-11-27MP00117 MPM Regenecare HA Spray 4 fl.oz.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66977-117-04REGENECARE HA120 mL in 1 BOTTLEGEL1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66977-117-04ML - Milliliter66977-11726758f4e-e318-4d89-b7a4-86416d9069da12013-12-02

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
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBREGENECARE 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
66977-117REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL LLC]3Current NDC, Legacy NDC, 1 package rows20240518_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 87 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Pharmacy Hydrocortisone with AloeHYDROCORTISONEAmerisourceBergen0c544792-63d9-400c-9888-207c44fdc75e2025-07-08WarningsExact identifier
application number: M017
Good Neighbor Pharmacy HydrocortisoneHYDROCORTISONEAmerisourceBergen58b0b7ba-e547-4e0f-b04d-8e1e6a5d4fcf2025-07-08WarningsExact identifier
application number: M017
Publix HydroHYDROCORTISONEPublix Super Markets Inc29296b0f-0eed-4bb9-8727-c25c2bcf9fd62025-07-08WarningsExact identifier
application number: M017
Publix hydro plusHYDROCORTISONEPublix Super Markets Inca00d82c1-6b09-424a-be78-2603eee3fb9d2025-07-08WarningsExact identifier
application number: M017
TattooTATTOO CREAMPerfso (HK) Co., Limited39773cab-12df-4520-e063-6294a90abc5b2025-07-08WarningsExact identifier
application number: M017
Neutrogena Sun Rescue After Sun Medicated ReliefCAMPHOR (SYNTHETIC)Kenvue Brands LLCc95c5b64-b90f-1143-e053-2a95a90aa03c2025-07-07WarningsExact identifier
application number: M017
sunmark HydrocortisoneHYDROCORTISONEStrategic Sourcing Services LLC210079e9-3d2f-4489-b468-b96b145034ed2025-07-07WarningsExact identifier
application number: M017
Relief GelLIDOCAINE HCLGood Clean Love, Inc.e5fa2265-ccb7-750c-e053-2995a90aa51e2025-07-07WarningsExact identifier
application number: M017
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONESun Pharmaceutical Industries, Inc.09ac2749-a60f-4039-8c80-a0d2eaf50c342025-07-07WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESun Pharmaceutical Industries, Inc.2ada9ec2-1c28-4da2-8639-07b3193ffb322025-07-03WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONESun Pharmaceutical Industries, Inc.caa2fd64-e262-4d7c-ad8a-69f506feba8c2025-07-03WarningsExact identifier
application number: M017
Stopain Extra StrengthMENTHOLTroy Manufacturing, Inc.07e9a235-6d10-4407-8729-beaf936e97ad2025-07-03WarningsExact identifier
application number: M017
Blue Ice Topical Analgesic GelICE GELInternational Wholesale397cd306-078d-5b7d-e063-6294a90a8bbc2025-07-03WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINE, MENTHOLVive Health LLC236ccc6d-21b7-6153-e063-6394a90a46342025-07-02WarningsExact identifier
application number: M017
AsperFlex MAXLIDOCAINE 4% WITH MENTHOL 1%Akron Pharma Inc.ccf6172b-350a-4b78-b844-f84bf17c491f2025-07-02WarningsExact identifier
application number: M017
METHYL SALICYLATE 25%METHYL SALICYLATEOncora Pharma, LLC3766e3a9-94a8-4c3e-e063-6394a90aa24a2025-07-01WarningsExact identifier
application number: M017
Diphenhydramine Hydrochloride and Zinc AcetateDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATESun Pharmaceutical Industries, Inc.c89e3de8-7d71-485c-8fc5-2832d6024f162025-07-01WarningsExact identifier
application number: M017
Westlake Outdoor Pain and Itch RelievingLIDOCAINE 4% PAIN AND ITCH RELIEVINGWESTLAKE HB PHARMA3c563b28-4f4f-9d0c-e063-6294a90adf732025-07-01WarningsExact identifier
application number: M017
Cortizone 10 Water ResistantHYDROCORTISONEChattem, Inc.118e55e7-241f-44c4-959e-09bf6221bd772025-07-01WarningsExact identifier
application number: M017
Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.38c1616e-3b09-0669-e063-6294a90a2c862025-06-29WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010769lidocaine HCl 2 % Topical SprayPSN0eee554f-dfe0-433a-9665-8bdb952298884
1012594REGENECARE HA 2 % Topical Spray HydrogelPSN0eee554f-dfe0-433a-9665-8bdb952298884
1012594lidocaine hydrochloride 20 MG/ML Topical Spray [Regenecare]SBD0eee554f-dfe0-433a-9665-8bdb952298884
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCD0eee554f-dfe0-433a-9665-8bdb952298884
1010769lidocaine hydrochloride 2 % Topical SpraySY0eee554f-dfe0-433a-9665-8bdb952298884
1012594Regenecare 0.02 MG/MG Topical Spray GelSY0eee554f-dfe0-433a-9665-8bdb952298884
1012594Regenecare 2 % Topical Spray GelSY0eee554f-dfe0-433a-9665-8bdb952298884
1012594Regenecare 20 MG/ML Topical SpraySY0eee554f-dfe0-433a-9665-8bdb952298884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66977-117-0466977011704120 mL in 1 BOTTLE (66977-117-04) 120 ml2009-06-010000-00-00NoNoCurrent