Gumnumb Topical Anesthetic
- Product NDC
- 24794-224
- 11-digit product format
- 247940224
- Labeler code
- 24794
- Product ID
- 24794-224_d618ffce-a6f6-251b-e053-2a95a90a141b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine
- Dosage form
- GEL
- Route
- DENTAL
- Labeler
- Crosstex International Inc.
- Application
- part356
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2013-07-01
- Marketing end
- 0000-00-00
- Substance
- BENZOCAINE
- Active strength
- 200 mg/g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 24794-224-30 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5a66-d83d-e063-dadaa90ab31f | 7d3e8fba-7a7a-491b-b855-2be468c5dc0e |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 24794-224-30 | Gumnumb Topical Anesthetic | 30 g in 1 JAR | GEL | 30 | 5 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BENZOCAINE | ACTIVE INGREDIENT | U3RSY48JW5 | GUMNUMB TOPICAL ANESTHETIC (BENZOCAINE) GEL [CROSSTEX INTERNATIONAL INC.] | 1 | |
| BENZOCAINE | ACTIVE MOIETY | U3RSY48JW5 | GUMNUMB TOPICAL ANESTHETIC (BENZOCAINE) GEL [CROSSTEX INTERNATIONAL INC.] | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | GUMNUMB TOPICAL ANESTHETIC (BENZOCAINE) GEL [CROSSTEX INTERNATIONAL INC.] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | GUMNUMB TOPICAL ANESTHETIC (BENZOCAINE) GEL [CROSSTEX INTERNATIONAL INC.] | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | GUMNUMB TOPICAL ANESTHETIC (BENZOCAINE) GEL [CROSSTEX INTERNATIONAL INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 238910 | benzocaine 20 % Oral Gel | PSN | 7d3e8fba-7a7a-491b-b855-2be468c5dc0e | 5 |
| 645497 | GumNumb 20 % Oral Gel | PSN | 7d3e8fba-7a7a-491b-b855-2be468c5dc0e | 5 |
| 645497 | benzocaine 0.2 MG/MG Oral Gel [Gum Numb Gel] | SBD | 7d3e8fba-7a7a-491b-b855-2be468c5dc0e | 5 |
| 238910 | benzocaine 0.2 MG/MG Oral Gel | SCD | 7d3e8fba-7a7a-491b-b855-2be468c5dc0e | 5 |
| 238910 | benzocaine 20 % (180-220 MG per 1 GM) Oral Gel | SY | 7d3e8fba-7a7a-491b-b855-2be468c5dc0e | 5 |
| 645497 | Gum Numb Gel 0.2 MG/MG Oral Gel | SY | 7d3e8fba-7a7a-491b-b855-2be468c5dc0e | 5 |
| 645497 | Gumnumb 0.2 MG/MG Oral Gel | SY | 7d3e8fba-7a7a-491b-b855-2be468c5dc0e | 5 |
| 645497 | Gumnumb 20 % Oral Gel | SY | 7d3e8fba-7a7a-491b-b855-2be468c5dc0e | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 24794-224-30 | 24794022430 | 30 g in 1 JAR (24794-224-30) | 30 g | 2018-07-01 | 0000-00-00 | No | No | Current |