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

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.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	62942-101		I	Inactivated by FDA	2026-08-11
excluded package	package	62942-101	62942-101-03	I	Inactivated by FDA	2026-08-11
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.

Historic NDC status page 1 of 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62942-101-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62942-101-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62942-101-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62942-101-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62942-101-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62942-101-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62942-101-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62942-101-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62942-101-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62942-101-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62942-101-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62942-101-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62942-101-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62942-101-12	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62942-101-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62942-101-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62942-101-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62942-101-12	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62942-101-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62942-101-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	62942-101-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	62942-101-12	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	62942-101-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	62942-101-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	62942-101-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	62942-101-12	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	62942-101-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	62942-101-12	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	62942-101-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	62942-101-12	`1332a3947898…`	`d4bfe170f9cd…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
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 table
Package NDC	Product	Description	Form	Quantity	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 table
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 table
Ingredient	Type	UNII	DailyMed label	SPL version
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#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62942-101	DEBACTEROL CANKER SORE PAIN RELIEF (PHENOLSULFONIC ACID AND SULFURIC ACID) SOLUTION [EPIEN MEDICAL INC]	6	Legacy NDC, 4 package rows	20211201_15d22ca4-503e-2751-e054-00144ff8d46c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L74LRO149A	PHENOLSULFONIC ACID	98-67-9	PHENOLSULFONIC ACID
O40UQP6WCF	SULFURIC ACID	7664-93-9	SULFURIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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 table
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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEBACTEROL Canker Sore Pain Relief - EPIEN Medical Inc	EPIEN Medical Inc	2021-11-30	HUMAN PRESCRIPTION DRUG LABEL	6