Maximum Strength Betadine Clear
- Product NDC
- 67618-183
- 11-digit product format
- 676180183
- Labeler code
- 67618
- Product ID
- 67618-183_3a3f54a7-c041-83d1-e063-6294a90aaa51
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzalkonium Cl and Pramoxine HCl
- Dosage form
- SPRAY
- Route
- TOPICAL
- Labeler
- Atlantis Consumer Healthcare, Inc.
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-12-22
- Substance
- BENZALKONIUM CHLORIDE; PRAMOXINE HYDROCHLORIDE
- Active strength
- .13; 1 mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Maximum Strength Betadine Clear
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZALKONIUM CHLORIDE | .13 mg/mL |
| PRAMOXINE HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F5UM2KM3W7, 88AYB867L5 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67618-183-06 | Maximum Strength Betadine Clear | 177 mL in 1 BOTTLE | SPRAY | 177 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67618-183 | MAXIMUM STRENGTH BETADINE CLEAR (BENZALKONIUM CL AND PRAMOXINE HCL) SPRAY [ATLANTIS CONSUMER HEALTHCARE, INC.] | 1 | Current NDC, 1 package rows | 20240111_31b94a76-1536-47c0-ab03-e487c2625c58.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67618-183-06 | 67618018306 | 177 mL in 1 BOTTLE (67618-183-06) | 177 ml | 2023-12-22 | No | No | Current |