Maximum Strength Betadine Clear
- Product NDC
- 67618-183
- 11-digit product format
- 676180183
- Labeler code
- 67618
- Product ID
- 67618-183_074e0e6b-8391-4541-b628-bd74a5e7c29c
- 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
- 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
- Maximum Strength Betadine Clear
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZALKONIUM CHLORIDE | .13 mg/mL |
| PRAMOXINE HYDROCHLORIDE | 1 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F5UM2KM3W7 | Internal UNII lookup |
| 88AYB867L5 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 31b94a76-1536-47c0-ab03-e487c2625c58 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| 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#
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 |
|---|---|---|---|---|---|---|
| Antibiotic Application | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | CMC Group, Inc. | da436c35-a98f-4df7-9d23-885564734cef | 2025-01-13 | Warnings | M003 |
| Burn Treatment | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | CMC Group Inc. | 9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40 | 2025-01-13 | Warnings | M003 |
| Hand Sanitizer | ALCOHOL | CMC Group Inc. | dcca50e6-0935-401d-a23e-be4d1231dde9 | 2025-01-13 | Warnings | M003 |
| Refill 2 | BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | CMC Group, Inc. | 45dde3f0-546c-4ec5-beb0-c3d0432f4983 | 2025-01-13 | Warnings | M003 |
| Refill 3 | BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE | CMC Group Inc. | e5cb395f-5037-4b0e-9c9d-2d78b5b01b25 | 2025-01-13 | Warnings | M003 |
| Refill 4 | ISOPROPYL ALCOHOL | CMC Group Inc. | 6f4a4538-7522-4bcf-b3cf-8dea60438a4d | 2025-01-13 | Warnings | M003 |
| Refill 6 | ALCOHOL, WATER | CMC Group, Inc. | 7849ae59-5484-4b86-a0b9-ec9b93d9afe0 | 2025-01-13 | Warnings | M003 |
| EVR Povidone lodine Wipe | POVIDONE LODINE | Changzhou Maokang Medical Products Co., Ltd. | 2b57e301-74e0-e1db-e063-6294a90a6c18 | 2025-01-10 | Warnings | M003 |
| EVR Sting Relief Wipe | BENZOCAINE, ISOPROPYL ALCOHOL | Changzhou Maokang Medical Products Co., Ltd. | 2b584d09-916c-00f8-e063-6294a90adbcf | 2025-01-10 | Warnings | M003 |
| Medzah Ditek Alcohol Prep Pads | ISOPROPYL ALCOHOL | Medzah Industries | 4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac | 2025-01-10 | Warnings | M003 |
| Alcohol Prep Pad-Large | ISOPROPYL ALCOHOL | Global Biomedical Technologies, LLC | 93d00515-e93f-48a3-b66b-7d933e734e54 | 2025-01-10 | Warnings | M003 |
| DERMADIVE ULTRACARE - TETRAID | BENZALKONIUM CHLORIDE | Releaf Technologies LLC | 025c0b33-73ca-334b-e063-6394a90ad668 | 2025-01-09 | Warnings | M003 |
| Drs. pharmacy triple antibiotic | BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENT | OL PHARMA TECH, LLC | bb730976-0045-c0ae-e053-2a95a90af34e | 2025-01-09 | Warnings | M003 |
| Drs. Antibiotic Bacitracin | BACITRACIN | OL PHARMA TECH, LLC | c26493c4-0bc1-5fdc-e053-2995a90a81e6 | 2025-01-09 | Warnings | M003 |
| Drs. Pharmacy Triple Antibiotic Plus | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE | OL PHARMA TECH, LLC Drs PHARMACY | d037bfb8-0d8c-4eda-e053-2995a90ae1f2 | 2025-01-09 | Warnings | M003 |
| BACTINE MAX | BACTINE MAX WOUND WASH | WellSpring Pharmaceutical Corporation | 39b26c28-93e0-41a9-8018-f73525ebc015 | 2025-01-08 | Warnings | M003 |
| sterile | POVIDONE-IODINE | Asia Dynamics Inc., d/b/a ADI Medical | 0658a0c8-f5ec-b380-e063-6394a90afff5 | 2025-01-08 | Warnings | M003 |
| Betadine Surgical Scrub | POVIDONE-IODINE | Atlantis Consumer Healthcare, Inc. | 1ad39e11-ea1e-44a4-8224-93f8135436c2 | 2025-01-06 | Warnings | M003 |
| First Aid Antiseptic | BENZALKONIUM CHLORIDE | Water-Jel Technologies | 2b3cb958-c0c4-47fd-8338-7c7821135f2b | 2025-01-06 | Warnings | M003 |
| Instant Hand Sanitizer | ALCOHOL | Water-Jel Technologies | 54e62104-8076-41db-afe5-6dc5c3563acc | 2025-01-06 | Warnings | M003 |
Packages#
| 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 |