SULFAMYLON

Product NDC: 16571-723
11-digit product format: 165710723
Labeler code: 16571
Product ID: 16571-723_58d3a059-d175-4740-bf57-f156588c99b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mafenide acetate
Dosage form: CREAM
Route: TOPICAL
Labeler: Rising Pharma Holdings, Inc.
Application: NDA016763
Marketing category: NDA
Marketing start: 2020-05-18
Substance: MAFENIDE ACETATE
Active strength: 85 mg/g
Pharmacologic classes: Methylated Sulfonamide Antibacterial [EPC], Methylated Sulfonamides [EXT]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016763-001	SULFAMYLON	MAFENIDE ACETATE	EQ 85MG BASE/GM	CREAM / TOPICAL		RLD, RS, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016763-001	SULFAMYLON	EQ 85MG BASE/GM	CREAM / TOPICAL	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: SULFAMYLON
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MAFENIDE ACETATE	85 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RQ6LP6Z0WY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
201185	Internal RxNorm lookup
311406	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
008eaa23-8f19-4e39-85ff-540c1c834a9e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
a68e9f57-2575-4959-9f08-10a33b538785	Product name	1	20170828
85be6c97-d74a-e96c-07f8-9af4f297edab	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
16571-723-12	2023-07-31	008eaa23-8f19-4e39-85ff-540c1c834a9e
16571-723-48	2023-07-31	008eaa23-8f19-4e39-85ff-540c1c834a9e
16571-723-60	2023-07-31	008eaa23-8f19-4e39-85ff-540c1c834a9e
16571-723-12	2023-07-28	008eaa23-8f19-4e39-85ff-540c1c834a9e
16571-723-48	2023-07-28	008eaa23-8f19-4e39-85ff-540c1c834a9e
16571-723-60	2023-07-28	008eaa23-8f19-4e39-85ff-540c1c834a9e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16571-723-12	SULFAMYLON	113.4 g in 1 TUBE	CREAM	113.4	2
16571-723-12	SULFAMYLON	1 in 1 CARTON	CREAM	1	2
16571-723-48	SULFAMYLON	453.6 g in 1 JAR	CREAM	453.6	2
16571-723-60	SULFAMYLON	56.7 g in 1 TUBE	CREAM	56.7	2
16571-723-60	SULFAMYLON	1 in 1 CARTON	CREAM	1	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-723-48	GM - Gram	16571-723	e386dedc-a477-4229-b104-c39cc92524d1	1	2021-06-02
16571-723-60	GM - Gram	16571-723	57d7123b-a209-4df3-96c6-edb95146516e	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-723	SULFAMYLON (MAFENIDE ACETATE) CREAM [RISING PHARMA HOLDINGS, INC.]	2	Current NDC, Legacy NDC, 5 package rows	20230731_008eaa23-8f19-4e39-85ff-540c1c834a9e.zip

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SULFAMYLON	MAFENIDE ACETATE	Rising Pharma Holdings, Inc.	008eaa23-8f19-4e39-85ff-540c1c834a9e	2023-07-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016763 application number: NDA016763 ndc (product): 16571-723

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RQ6LP6Z0WY	MAFENIDE ACETATE	13009-99-9	MAFENIDE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311406	mafenide acetate 8.5 % Topical Cream	PSN	008eaa23-8f19-4e39-85ff-540c1c834a9e	2
201185	Sulfamylon 8.5 % Topical Cream	PSN	008eaa23-8f19-4e39-85ff-540c1c834a9e	2
201185	mafenide 85 MG/ML Topical Cream [Sulfamylon]	SBD	008eaa23-8f19-4e39-85ff-540c1c834a9e	2
311406	mafenide 85 MG/ML Topical Cream	SCD	008eaa23-8f19-4e39-85ff-540c1c834a9e	2
311406	mafenide (as mafenide acetate) 8.5 % Topical Cream	SY	008eaa23-8f19-4e39-85ff-540c1c834a9e	2
201185	Sulfamylon 8.5 % Topical Cream	SY	008eaa23-8f19-4e39-85ff-540c1c834a9e	2
201185	Sulfamylon 85 MG/ML Topical Cream	SY	008eaa23-8f19-4e39-85ff-540c1c834a9e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-723-12	16571072312	1 TUBE in 1 CARTON (16571-723-12) / 113.4 g in 1 TUBE	1 tube	2020-05-18	0000-00-00	No	No	Current
16571-723-48	16571072348	453.6 g in 1 JAR (16571-723-48)	453.6 g	2020-05-18	0000-00-00	No	No	Current
16571-723-60	16571072360	1 TUBE in 1 CARTON (16571-723-60) / 56.7 g in 1 TUBE	1 tube	2020-05-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SULFAMYLON - Rising Pharma Holdings, Inc. \| Kavis Pharma LLC	Rising Pharma Holdings, Inc. \| Kavis Pharma LLC	2023-07-03	Human Prescription Drug Label	2