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

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 Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010769, 1012594

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66977-117-042024-05-17C16284748780-19855d018-d8bf-cd31-e053-dbdaa90ab51aMP00117 MPM Regenecare HA Spray 4 fl.oz.
66977-117-042024-01-30C16284748780-19855d018-d8bf-cd31-e053-dbdaa90ab51aMP00117 MPM Regenecare HA Spray 4 fl.oz.
66977-117-042022-03-16C16284748780-19855d018-d8bf-cd31-e053-dbdaa90ab51aMP00117 MPM Regenecare HA Spray 4 fl.oz.
66977-117-042019-11-27C16284748780-19855d018-d8bf-cd31-e053-dbdaa90ab51aMP00117 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

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