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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- REGENECARE HA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LIDOCAINE HYDROCHLORIDE | 20 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V13007Z41A |
| Rxcui | 1011852, 2604879 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 66977-107-03 | 2024-07-16 | C162847 | 48780-1 | 9855d018-d90a-cd31-e053-dbdaa90ab51a | MPM Regenecare HA Gel (MP00107 - 3oz., MPoo108 - 4mL) |
| 66977-107-03 | 2024-07-16 | C162847 | 48780-1 | 9855d018-d90a-cd31-e053-dbdaa90ab51a | MPM Regenecare HA Gel (MP00107 - 3oz., MP00108 - 4mL, MP00112 - 0.5oz) |
| 66977-107-03 | 2024-01-30 | C162847 | 48780-1 | 9855d018-d90a-cd31-e053-dbdaa90ab51a | MPM Regenecare HA Gel (MP00107 - 3oz., MPoo108 - 4mL) |
| 66977-107-03 | 2024-01-30 | C162847 | 48780-1 | 9855d018-d90a-cd31-e053-dbdaa90ab51a | MPM Regenecare HA Gel (MP00107 - 3oz., MP00108 - 4mL, MP00112 - 0.5oz) |
| 66977-107-03 | 2022-03-08 | C162847 | 48780-1 | 9855d018-d90a-cd31-e053-dbdaa90ab51a | MPM Regenecare HA Gel (MP00107 - 3oz., MPoo108 - 4mL) |
| 66977-107-03 | 2022-03-08 | C162847 | 48780-1 | 9855d018-d90a-cd31-e053-dbdaa90ab51a | MPM Regenecare HA Gel (MP00107 - 3oz., MP00108 - 4mL, MP00112 - 0.5oz) |
| 66977-107-25 | 2022-03-08 | C162847 | 48780-1 | 9855d018-d90a-cd31-e053-dbdaa90ab51a | MPM Regenecare HA Gel (MP00107 - 3oz., MPoo108 - 4mL) |
| 66977-107-25 | 2022-03-08 | C162847 | 48780-1 | 9855d018-d90a-cd31-e053-dbdaa90ab51a | MPM Regenecare HA Gel (MP00107 - 3oz., MP00108 - 4mL, MP00112 - 0.5oz) |
| 66977-107-03 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d90a-cd31-e053-dbdaa90ab51a | MPM Regenecare HA Gel (MP00107 - 3oz., MPoo108 - 4mL) |
| 66977-107-03 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d90a-cd31-e053-dbdaa90ab51a | MPM Regenecare HA Gel (MP00107 - 3oz., MP00108 - 4mL, MP00112 - 0.5oz) |
| 66977-107-25 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d90a-cd31-e053-dbdaa90ab51a | MPM Regenecare HA Gel (MP00107 - 3oz., MPoo108 - 4mL) |
| 66977-107-25 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d90a-cd31-e053-dbdaa90ab51a | MPM Regenecare HA Gel (MP00107 - 3oz., MP00108 - 4mL, MP00112 - 0.5oz) |
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 Socrata Ingredients#
Ingredient, Type, UNII table| 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#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66977-107 | REGENECARE HA (LIDOCAINE HCL) GEL [MPM MEDICAL LLC] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240717_c3eec066-38e8-4617-b34d-2f72ffb7a324.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Historical |
| 66977-107-05 | 66977010705 | 14.17 g in 1 TUBE (66977-107-05) | 14.17 g | 2007-01-05 | | No | No | Historical |