DEBACTEROL Canker Sore Pain Relief
- Product NDC
- 62942-101
- Requested package NDC
- 62942-101-12
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 62942-101 | 62942-101-12 | I | Inactivated by FDA | 2026-08-11 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
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 |
|---|---|---|---|---|---|---|---|---|
| 62942-101-12 | 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 |