DEBACTEROL Canker Sore Pain Relief
- Product NDC
- 62942-101
- 11-digit product format
- 629420101
- Labeler code
- 62942
- Product ID
- 62942-101_d208b68b-9c84-c2a0-e053-2a95a90a351b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenolsulfonic Acid and Sulfuric Acid
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- EPIEN Medical Inc
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 1996-09-01
- Marketing end
- 0000-00-00
- Substance
- PHENOLSULFONIC ACID; SULFURIC ACID
- Active strength
- 1 g/mL; g/mL
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 62942-101-03 | 2023-01-30 | C162847 | 48780-1 | f386c64a-350b-0266-e053-dadaa90a7c1a | 15d22ca4-503e-2751-e054-00144ff8d46c |
| 62942-101-12 | 2023-01-30 | C162847 | 48780-1 | f386c64a-350b-0266-e053-dadaa90a7c1a | 15d22ca4-503e-2751-e054-00144ff8d46c |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62942-101-02 | DEBACTEROL Canker Sore Pain Relief | 0.2 mL in 1 APPLICATOR | SOLUTION | 0.2 | 6 | |
| 62942-101-03 | DEBACTEROL Canker Sore Pain Relief | 1 in 1 BOX | SOLUTION | 1 | 6 | |
| 62942-101-03 | DEBACTEROL Canker Sore Pain Relief | 1.5 mL in 1 VIAL, GLASS | SOLUTION | 1.5 | 6 | |
| 62942-101-12 | DEBACTEROL Canker Sore Pain Relief | 12 in 1 BOX | SOLUTION | 12 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62942-101-02 | EA - Each | 62942-101 | 3e3898de-e13e-48e5-af95-6ef3baea358e | 1 | 2014-10-03 |
| 62942-101-03 | ML - Milliliter | 62942-101 | 08486f6f-8777-4d26-a41f-b0dd645c77f6 | 1 | 2015-06-09 |
| 62942-101-12 | EA - Each | 62942-101 | 19a0dc8b-d766-4d74-affb-4a9c2b470e84 | 1 | 2015-09-10 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PHENOLSULFONIC ACID | ACTIVE INGREDIENT | L74LRO149A | DEBACTEROL CANKER SORE PAIN RELIEF (PHENOLSULFONIC ACID AND SULFURIC ACID) SOLUTION [EPIEN MEDICAL INC] | 1 | |
| SULFURIC ACID | ACTIVE INGREDIENT | O40UQP6WCF | DEBACTEROL CANKER SORE PAIN RELIEF (PHENOLSULFONIC ACID AND SULFURIC ACID) SOLUTION [EPIEN MEDICAL INC] | 1 | |
| PHENOLSULFONIC ACID | ACTIVE MOIETY | L74LRO149A | DEBACTEROL CANKER SORE PAIN RELIEF (PHENOLSULFONIC ACID AND SULFURIC ACID) SOLUTION [EPIEN MEDICAL INC] | 1 | |
| SULFURIC ACID | ACTIVE MOIETY | O40UQP6WCF | DEBACTEROL CANKER SORE PAIN RELIEF (PHENOLSULFONIC ACID AND SULFURIC ACID) SOLUTION [EPIEN MEDICAL INC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DEBACTEROL CANKER SORE PAIN RELIEF (PHENOLSULFONIC ACID AND SULFURIC ACID) SOLUTION [EPIEN MEDICAL INC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1369589 | Debacterol 50 % / 30 % Medicated Pad | PSN | 15d22ca4-503e-2751-e054-00144ff8d46c | 6 |
| 1547711 | DEBACTEROL 50 % / 30 % Mucous Membrane Topical Solution | PSN | 15d22ca4-503e-2751-e054-00144ff8d46c | 6 |
| 1245974 | sulfonated phenol 50 % / sulfuric acid 30 % Medicated Pad | PSN | 15d22ca4-503e-2751-e054-00144ff8d46c | 6 |
| 477215 | sulfonated phenol 50 % / sulfuric acid 30 % Mucous Membrane Topical Solution | PSN | 15d22ca4-503e-2751-e054-00144ff8d46c | 6 |
| 1369589 | sulfonated phenol 500 MG/ML / sulfuric acid 300 MG/ML Medicated Pad [Debacterol] | SBD | 15d22ca4-503e-2751-e054-00144ff8d46c | 6 |
| 1547711 | sulfonated phenol 500 MG/ML / sulfuric acid 300 MG/ML Mucous Membrane Topical Solution [Debacterol] | SBD | 15d22ca4-503e-2751-e054-00144ff8d46c | 6 |
| 1245974 | sulfonated phenol 500 MG/ML / sulfuric acid 300 MG/ML Medicated Pad | SCD | 15d22ca4-503e-2751-e054-00144ff8d46c | 6 |
| 477215 | sulfonated phenol 500 MG/ML / sulfuric acid 300 MG/ML Mucous Membrane Topical Solution | SCD | 15d22ca4-503e-2751-e054-00144ff8d46c | 6 |
| 1369589 | Debacterol (sulfonated phenol 50 % / sulfuric acid 30 % ) Mucosal Swab | SY | 15d22ca4-503e-2751-e054-00144ff8d46c | 6 |
| 1547711 | Debacterol 50 % / 30 % Mucous Membrane Topical Solution | SY | 15d22ca4-503e-2751-e054-00144ff8d46c | 6 |
| 1245974 | sulfonated phenol 50 % / sulfuric acid 30 % Dental Swab | SY | 15d22ca4-503e-2751-e054-00144ff8d46c | 6 |
| 1245974 | sulfonated phenol 50 % / sulfuric acid 30 % Medicated Pad | SY | 15d22ca4-503e-2751-e054-00144ff8d46c | 6 |
| 477215 | sulfonated phenol 50 % / sulfuric acid 30 % Mucous Membrane Topical Solution | SY | 15d22ca4-503e-2751-e054-00144ff8d46c | 6 |
| 1547711 | sulfonated phenol 50 % / sulfuric acid 30 % Mucous Membrane Topical Solution [Debacterol] | SY | 15d22ca4-503e-2751-e054-00144ff8d46c | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62942-101-02 | 62942010102 | 0.2 mL in 1 APPLICATOR | 0.2 ml | Historical | ||||
| 62942-101-03 | 62942010103 | 1 VIAL, GLASS in 1 BOX (62942-101-03) > 1.5 mL in 1 VIAL, GLASS | 1996-09-01 | 0000-00-00 | No | No | Current | |
| 62942-101-12 | 62942010112 | 12 APPLICATOR in 1 BOX (62942-101-12) > .2 mL in 1 APPLICATOR (62942-101-02) | 12 applicator | 1996-09-01 | 0000-00-00 | No | No | Current |