Silver Sulfadiazine

Product NDC: 45865-642
11-digit product format: 458650642
Labeler code: 45865
Product ID: 45865-642_7205c0e2-d7be-3451-e053-2a95a90a69b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Silver Sulfadiazine
Dosage form: CREAM
Route: TOPICAL
Labeler: Medsource Pharmaceuticals
Application: NDA018810
Marketing category: NDA
Marketing start: 1985-12-23
Marketing end: 0000-00-00
Substance: SILVER SULFADIAZINE
Active strength: 10 mg/g
Pharmacologic classes: Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	45865-642		I	Inactivated by FDA		2026-08-17
excluded package	package	45865-642	45865-642-01	I	Inactivated by FDA		2026-08-17

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-642-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-642-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-642-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-642-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-642-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-642-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-642-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-642-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-642-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N018810-001	THERMAZENE	SILVER SULFADIAZINE	1%	CREAM / TOPICAL	AB		1985-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N018810-001	AB

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N018810-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018810-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018810-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018810-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018810-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018810-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018810-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018810-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018810-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018810-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018810-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018810-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018810-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018810-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018810-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018810-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018810-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018810-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018810-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018810-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018810-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018810-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018810-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018810-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018810-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018810-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018810-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018810-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018810-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018810-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018810-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018810-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018810-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018810-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018810-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018810-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018810-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018810-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018810-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018810-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
52d15095-bb55-0cfb-f7b0-5be5a913b7db	Product name	1	20140508
6cca4355-1206-91f7-02de-17eef38a8622	Product name	1	20140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-642-01	2025-01-30	C162847	48780-1	2cef2736-b50c-d83d-e063-dadaa90ab31f	7205c0e2-d7bd-3451-e053-2a95a90a69b0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-642-01	Silver Sulfadiazine	25 g in 1 TUBE	CREAM	25		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-642	SILVER SULFADIAZINE CREAM [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 1 package rows	20180728_7205c0e2-d7bd-3451-e053-2a95a90a69b0.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Silver sulfadiazine	SILVER SULFADIAZINE	Ascend Laboratories, LLC	b4d6694f-2b0a-4d64-9e05-2fef6d8e60d9	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Thermazene Silver Sulfadiazine	SILVER SULFADIAZINE	Preferred Pharmaceuticals, Inc.	42c3ece4-0df0-4ed8-ac0f-a65fad19eed7	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Asclemed USA, Inc.	4d9aa72e-b8dc-4ea3-be44-80f03ba81982	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	A-S Medication Solutions	72ca5cb5-14d2-45e4-8b53-ed5809b0aeca	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	A-S Medication Solutions	067895f9-a797-4cbd-a3d2-d611d512fe5b	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Advanced Rx Pharmacy of Tennessee, LLC	f1a0f489-0d9e-66c4-e053-2a95a90a063d	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	A-S Medication Solutions	a4051ae4-f1ef-4082-920f-97d176b4cef2	2024-11-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Proficient Rx LP	532d776e-54b3-4d4f-bb7a-94927bfba4d2	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	A-S Medication Solutions	475953ba-b555-474c-9bcd-8cd314cc0d1f	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W46JY43EJR	SILVER SULFADIAZINE	22199-08-2	SILVER SULFADIAZINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106351	silver sulfADIAZINE 1 % Topical Cream	PSN	7205c0e2-d7bd-3451-e053-2a95a90a69b0	1
106351	silver sulfadiazine 10 MG/ML Topical Cream	SCD	7205c0e2-d7bd-3451-e053-2a95a90a69b0	1
106351	silver sulfadiazine 1 % Topical Cream	SY	7205c0e2-d7bd-3451-e053-2a95a90a69b0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-642-01	45865064201	25 g in 1 TUBE (45865-642-01)	25 g	2018-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Silver Sulfadiazine - Medsource Pharmaceuticals	Medsource Pharmaceuticals	2018-07-27	HUMAN PRESCRIPTION DRUG LABEL	1