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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Antiseptic
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZALKONIUM CHLORIDE | 1 mg/g |
| BENZOCAINE | 50 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F5UM2KM3W7, U3RSY48JW5 |
| Rxcui | 1245229 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 table| 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 table| 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 |
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 |
|---|
| 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 |