XtraCare Antibacterial Hand Cleanse
- Product NDC
- 57337-021
- 11-digit product format
- 573370021
- Labeler code
- 57337
- Product ID
- 57337-021_126c392a-2f26-cd97-e063-6294a90a4f99
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Triclosan
- Dosage form
- SOAP
- Route
- TOPICAL
- Labeler
- Rejoice International, Inc.
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-09-03
- Substance
- TRICLOSAN
- Active strength
- 3.3 mg/221mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- XtraCare Antibacterial Hand Cleanse
- Brand name suffix
- Original
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TRICLOSAN | 3.3 mg/221mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4NM5039Y5X | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1020118 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b5ce6663-fe82-4da1-923e-acea293d7a00 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57337-021-01 | 2024-02-28 | C162847 | 48780-1 | 1030e365-2d71-111a-e063-dadaa90a10e2 | XtraCare Antibacterial Hand Cleanse |
| 57337-021-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2d71-111a-e063-dadaa90a10e2 | XtraCare Antibacterial Hand Cleanse |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57337-021-01 | XtraCare Antibacterial Hand CleanseOriginal | 221 mL in 1 BOTTLE | SOAP | 221 | 5 |
DailyMed Socrata Ingredients#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Guardian Vaginal | BENZALKONIUM CHLORIDE | Eastern Century Pharmaceuticals | 1605ba44-02b7-4c72-9fec-89a5aa962b44 | 2024-04-24 | Warnings | M003 |
| Inverness Hygienic Ear Care Antiseptic | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | 0ccd72e7-16a2-47c7-9ce6-dffb63a0344b | 2024-04-18 | Warnings | M003 |
| Lovisa Piercing Care Solution | BENZALKONIUM CHLORIDE | The Richline Group, Inc. | 74f46b81-cc5b-4e3f-a36e-0bd86d370c22 | 2024-04-18 | Warnings | M003 |
| CliniClean BZK Cleansing Contains Benzalkonium Chloride | BENZALKONIUM CHLORIDE | HR HealthCare | b6916466-0931-408f-a430-0797a449c32e | 2024-04-18 | Warnings | M003 |
| Handy Solutions First Aid Kit | BENZALKONIUM CHLORIDE | Navajo Manufacturing Company Inc. | 130237ff-3db4-1288-e063-6394a90ab1af | 2024-04-16 | Warnings | M003 |
| BZK | BENZALKONIUM CHLORIDE | Henry Schein Inc. | ff877b63-fa58-4770-a882-694eda33203b | 2024-04-02 | Warnings | M003 |
| First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | M-star (Hubei) Health&Care Products Co., Ltd. | 8e1f35ff-d4e6-4940-ad8f-dce2b73e595d | 2024-04-01 | Warnings | M003 |
| Antiseptic Towelette TOALLITAS ANTISEPTICAS | BENZALKONIUM CHLORIDE | M-star (Hubei) Health&Care Products Co., Ltd. | b267e186-cf7a-458f-9c28-a48a8554af40 | 2024-04-01 | Warnings | M003 |
| Antiseptic Povidone Iodine Prep Pad | POVIDONE-IODINE | M-star (Hubei) Health&Care Products Co., Ltd. | fc76c1f3-b48e-4276-890d-5b8e5a894e62 | 2024-04-01 | Warnings | M003 |
| Novex Hand Sanitizer | BENZALKONIUM CHLORIDE | Natural Essentials, Inc. | 8b53dde5-c9f6-41c4-8ddb-bf0bf67008d3 | 2024-03-20 | Warnings | M003 |
| Antiseptic | BENZALKONIUM CHLORIDE 0.13% | Trifecta Pharmaceuticals USA, LLC. | 13f1c70f-3b44-8eef-e063-6294a90af634 | 2024-03-18 | Warnings | M003 |
| Burn Cream | BENZALKONIUM CHLORIDE, LIDOCAINE HCI | Trifecta Pharmaceuticals USA LLC | 1308ce91-2858-310a-e063-6394a90a6810 | 2024-03-06 | Warnings | M003 |
| Instant Hand Sanitizer - Cocoa Butter | ETHYL ALCOHOL | Rejoice International, Inc. | 97dee45e-53be-4b37-a427-fc24388c0e05 | 2024-02-28 | Warnings | M003 |
| Instant Hand Sanitizer Aloe Vera | ETHYL ALCOHOL | Rejoice International, Inc. | 1e28454c-f5d8-4d6e-91f9-bc4501b027c1 | 2024-02-28 | Warnings | M003 |
| Instant Hand Sanitizer - Clear | ETHYL ALCOHOL | Rejoice International, Inc. | f0e637d9-d61e-466d-9e05-f906639dbaca | 2024-02-28 | Warnings | M003 |
| Instant Hand Sanitizer | ETHYL ALCOHOL | Rejoice International, Inc. | 07b163e4-8f67-44e7-b5ef-f237023080e0 | 2024-02-28 | Warnings | M003 |
| Instant Hand Sanitizer - Ice Clear | ETHYL ALCOHOL | Rejoice International, Inc. | 605ec88a-2f4c-4716-8522-eb2748b43398 | 2024-02-28 | Warnings | M003 |
| Instant Hand Sanitizer - Original | ETHYL ALCOHOL | Rejoice International, Inc. | bb9cc886-275e-4996-99dc-529f928b4905 | 2024-02-28 | Warnings | M003 |
| Liquid Hand Cleanse | TRICLOSAN | Rejoice International, Inc. | 23ff5450-8308-41c0-9052-1ac4c4433d6c | 2024-02-28 | Warnings | M003 |
| XtraCare Antibacterial Hand Cleanse Original | TRICLOSAN | Rejoice International, Inc. | b5ce6663-fe82-4da1-923e-acea293d7a00 | 2024-02-28 | Warnings | M003 57337-021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1020118 | triclosan 0.15 % Medicated Liquid Soap | PSN | b5ce6663-fe82-4da1-923e-acea293d7a00 | 5 |
| 1020118 | triclosan 1.5 MG/ML Medicated Liquid Soap | SCD | b5ce6663-fe82-4da1-923e-acea293d7a00 | 5 |
| 1020118 | triclosan 0.15 % Medicated Liquid Soap | SY | b5ce6663-fe82-4da1-923e-acea293d7a00 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57337-021-01 | 57337002101 | 221 mL in 1 BOTTLE (57337-021-01) | 221 ml | 2013-09-03 | 0000-00-00 | No | No | Current |