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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 66977-107-03 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 66977-107-03 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 66977-107-03 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 66977-107-03 | 1332a3947898… | d4bfe170f9cd… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 66977-107-25 | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 66977-107-03 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 66977-107-25 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 66977-107-03 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 66977-107-25 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 66977-107-03 | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 66977-107-25 | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 66977-107-03 | 110d247fa046… | 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 |
|---|---|
| LIDOCAINE HYDROCHLORIDE | 20 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V13007Z41A | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c3eec066-38e8-4617-b34d-2f72ffb7a324 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66977-107-03 | REGENECARE HA | 85 g in 1 TUBE | GEL | 85 | 8 | |
| 66977-107-04 | REGENECARE HA | 4 g in 1 TUBE | GEL | 4 | 8 | |
| 66977-107-05 | REGENECARE HA | 14.17 g in 1 TUBE | GEL | 14.17 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66977-107-03 | GM - Gram | 66977-107 | 0f6fe96d-9a40-449e-b50a-c86e20b35336 | 1 | 2013-07-02 |
| 66977-107-25 | ML - Milliliter | 66977-107 | eae63e2a-b3b6-4bd0-a32d-dc55d058f221 | 1 | 2013-07-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | ACTIVE INGREDIENT | V13007Z41A | REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.] | 1 | |
| LIDOCAINE | ACTIVE MOIETY | 98PI200987 | REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.] | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.] | 1 | |
| BENZETHONIUM CHLORIDE | INACTIVE INGREDIENT | PH41D05744 | REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.] | 1 | |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 4Q93RCW27E | REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.] | 1 | |
| HYALURONATE SODIUM | INACTIVE INGREDIENT | YSE9PPT4TH | REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.] | 1 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1011852 | lidocaine HCl 2 % Topical Gel | PSN | c3eec066-38e8-4617-b34d-2f72ffb7a324 | 8 |
| 2604879 | REGENECARE HA 2 % Topical Gel | PSN | c3eec066-38e8-4617-b34d-2f72ffb7a324 | 8 |
| 2604879 | lidocaine hydrochloride 0.02 MG/MG Topical Gel [Regenecare] | SBD | c3eec066-38e8-4617-b34d-2f72ffb7a324 | 8 |
| 1011852 | lidocaine hydrochloride 0.02 MG/MG Topical Gel | SCD | c3eec066-38e8-4617-b34d-2f72ffb7a324 | 8 |
| 1011852 | lidocaine hydrochloride 2 % Topical Jelly | SY | c3eec066-38e8-4617-b34d-2f72ffb7a324 | 8 |
| 2604879 | Regenecare 2 % Topical Gel | SY | c3eec066-38e8-4617-b34d-2f72ffb7a324 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 66977-107-03 | 66977010703 | 85 g in 1 TUBE (66977-107-03) | 85 g | 2007-01-05 | 0000-00-00 | No | No | Current |
| 66977-107-04 | 66977010704 | 4 g in 1 TUBE (66977-107-04) | 4 g | 2007-01-05 | Yes | No | Current | |
| 66977-107-05 | 66977010705 | 14.17 g in 1 TUBE (66977-107-05) | 14.17 g | 2007-01-05 | No | No | Current |