Antiseptic
- Product NDC
- 61010-5300
- 11-digit product format
- 610105300
- Labeler code
- 61010
- Product ID
- 61010-5300_10d37ff3-97c6-9f55-e063-6294a90a656b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- benzalkonium chloride, benzocaine
- Dosage form
- SPRAY
- Route
- TOPICAL
- Labeler
- Safetec of America, Inc.
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-02-15
- Substance
- BENZALKONIUM CHLORIDE; BENZOCAINE
- Active strength
- 1; 50 mg/g; 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
- 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
- Antiseptic
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZALKONIUM CHLORIDE | 1 mg/g |
| BENZOCAINE | 50 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F5UM2KM3W7 | Internal UNII lookup |
| U3RSY48JW5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1245229 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 458e65f2-826d-4550-8c7d-17add2d7ba9a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 61010-5300-0 | 2024-02-13 | 61010-5300, Cut and Scrape Antiseptic |
| 61010-5300-2 | 2024-02-13 | 61010-5300, Cut and Scrape Antiseptic |
| 61010-5300-0 | 2024-01-30 | 61010-5300, Cut and Scrape Antiseptic |
| 61010-5300-2 | 2024-01-30 | 61010-5300, Cut and Scrape Antiseptic |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61010-5300-0 | Antiseptic | 60 g in 1 BOTTLE, SPRAY | SPRAY | 60 | 4 | |
| 61010-5300-2 | Antiseptic | 90 g in 1 BOTTLE, SPRAY | SPRAY | 90 | 4 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| benzalkonium chloride | ACTIVE INGREDIENT | F5UM2KM3W7 | ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] | 2 | |
| benzocaine | ACTIVE INGREDIENT | U3RSY48JW5 | ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] | 2 | |
| benzalkonium | ACTIVE MOIETY | 7N6JUD5X6Y | ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] | 2 | |
| benzocaine | ACTIVE MOIETY | U3RSY48JW5 | ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] | 2 | |
| isopropyl alcohol | INACTIVE INGREDIENT | ND2M416302 | ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61010-5300 | ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240214_458e65f2-826d-4550-8c7d-17add2d7ba9a.zip |
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 |
|---|---|---|---|---|---|---|
| Olimpo Antibacterial | BENZALKONIUM CHLORIDE 0.1% | Industria La Popular, S.A. | 597e3b3e-51f0-5fcf-e063-6394a90ac297 | 2026-08-20 | Warnings | M003 |
| Benzalkonium Chloride | BENZALKONIUM CHLORIDE TOWELETTES | Trifecta Pharmaceuticals USA LLC | 59811e67-57f0-4db1-e063-6294a90a2ad8 | 2026-08-20 | Warnings | M003 |
| inControl alcohol | ISOPROPYL ALCOHOL | H-E-B | 45dfbd7a-0ae1-4146-9527-5483c884e636 | 2026-08-18 | Warnings | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | The Kroger Co. | 52f6258f-4b4c-49f4-9bc7-40dc3918869d | 2026-08-17 | Warnings, Adverse reactions | M003 |
| 70% Isopropyl Rubbing Alcohol | ISOPROPYL RUBBING ALCOHOL | The Kroger Co. | b127bba1-ce0b-4142-8b7d-f12f062b0938 | 2026-08-17 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | The Kroger Co. | cd3f8779-9e57-4b23-a029-7424d4d4ab2a | 2026-08-17 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | The Kroger Co. | ca6c7f8a-d41a-4d77-817c-3dbdc40f890e | 2026-08-17 | Warnings, Adverse reactions | M003 |
| Alcohol Sanitizer Spray. | ETHYL ALCOHOL | Guangdong Yanze Biotechnology Co., Ltd. | 58fb9efe-43f0-1b7f-e063-6394a90a0145 | 2026-08-14 | Warnings | M003 |
| Povidone-Iodine | POVIDONE-IODINE | Major Pharmaceuticals | 59041ca3-a195-5a20-e063-6394a90a2ac9 | 2026-08-14 | Warnings | M003 |
| Alcohol Hand Sanitizer | ETHYL ALCOHOL | Guangdong Yanze Biotechnology Co., Ltd. | 58fa90dc-c3b5-787b-e063-6294a90a2e17 | 2026-08-13 | Warnings | M003 |
| SprinJene | ALCOHOL | Health and Natural Beauty USA Corp | 1853f023-f4db-4cd8-a4df-a439bc306cc3 | 2026-08-13 | Warnings | M003 |
| LUXURY IPA 70% | LUXURY ISOPROPYL ALCOHOL 70% 16OZ | TSM BRANDS LLC | 2240a9e0-dac5-54fa-e063-6394a90a35f5 | 2026-08-11 | Warnings | M003 |
| Ethyl alcohol | ETHYL ALCOHOL | Strategic Sourcing Services LLC | 4fec6f1f-0249-423f-bd3c-427aa6924c6f | 2026-08-10 | Warnings, Adverse reactions | M003 |
| antibacterial hand wipes (JUICY WATERMELON) | ANTIBACTERIAL HAND WIPES | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | 5883c43d-212b-af39-e063-6394a90ad652 | 2026-08-08 | Warnings | M003 |
| LIGHTS Antiseptic and Pain Relieving Prep Pad | ISOPROPYL ALCOHOL | Lights Medical Manufacture Co., Ltd. | 91cc7334-f610-487d-a895-3dda78c3372e | 2026-08-07 | Warnings | M003 |
| CVS Beauty Hydrating Hand Sanitizer SANDALWOOD MUSK | ETHYL ALCOHOL | CVS Pharmacy, Inc. | 60128fc3-b127-44ee-9e9b-384d322d213a | 2026-08-07 | Warnings | M003 |
| CVS Beauty Hydrating Hand Sanitizer Sea Salt and Lavender | ETHYL ALCOHOL | CVS Pharmacy, Inc. | 6c160826-ad98-4390-a07b-c92a2ae5b181 | 2026-08-07 | Warnings | M003 |
| antibacterial hand wipes (2257C) | ANTIBACTERIAL HAND WIPES (2257C) | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | 585a1c36-7bdc-4d4f-e063-6394a90ad6d2 | 2026-08-06 | Warnings | M003 |
| antibacterial hand wipes (Angel) | ANTIBACTERIAL HAND WIPES | Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. | 585c4a14-8dc9-3a08-e063-6394a90ab4f5 | 2026-08-06 | Warnings | M003 |
| Hydrating Hand Sanitizer ROSEWATER SPRITZ | ALCOHOL 75% | Guangzhou Ailizhuangsi Cosmetics Co., Ltd. | 585cb4fa-6016-1550-e063-6294a90a514d | 2026-08-06 | Warnings | M003 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1245229 | benzalkonium chloride 0.1 % / benzocaine 5 % Topical Spray | PSN | 458e65f2-826d-4550-8c7d-17add2d7ba9a | 4 |
| 1245229 | benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical Spray | SCD | 458e65f2-826d-4550-8c7d-17add2d7ba9a | 4 |
| 1245229 | benzalkonium Cl 0.1 % / benzocaine 5 % Topical Spray | SY | 458e65f2-826d-4550-8c7d-17add2d7ba9a | 4 |
| 1245229 | benzalkonium chloride 0.1 % / benzocaine 5 % Topical Spray | PSN | 35d06b38-55dd-e306-e063-6394a90aaf26 | 1 |
| 1245229 | benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical Spray | SCD | 35d06b38-55dd-e306-e063-6394a90aaf26 | 1 |
| 1245229 | benzalkonium Cl 0.1 % / benzocaine 5 % Topical Spray | SY | 35d06b38-55dd-e306-e063-6394a90aaf26 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61010-5300-0 | 61010530000 | 60 g in 1 BOTTLE, SPRAY (61010-5300-0) | 60 g | 2012-02-15 | 0000-00-00 | No | No | Current |
| 61010-5300-2 | 61010530002 | 90 g in 1 BOTTLE, SPRAY (61010-5300-2) | 90 g | 2012-02-15 | 0000-00-00 | No | No | Current |