Silver Sulfadiazine

Product NDC: 87063-078
11-digit product format: 870630078
Labeler code: 87063
Product ID: 87063-078_4908298d-e389-9450-e063-6394a90a5e75
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Silver Sulfadiazine
Dosage form: CREAM
Route: TOPICAL
Labeler: Asclemed USA, Inc.
Application: NDA018810
Marketing category: NDA
Marketing start: 1985-12-23
Substance: SILVER SULFADIAZINE
Active strength: 10 mg/g
Pharmacologic classes: Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
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 · 41 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
2026-02-19 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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018810-001	THERMAZENE	1%	CREAM / TOPICAL	AB	1985-12-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018810-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Silver Sulfadiazine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SILVER SULFADIAZINE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W46JY43EJR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
106351	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
4d9aa72e-b8dc-4ea3-be44-80f03ba81982	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
87063-078-05	Silver Sulfadiazine	50 g in 1 TUBE	CREAM	50	1
87063-078-10	Silver Sulfadiazine	1000 g in 1 JAR	CREAM	1000	1
87063-078-20	Silver Sulfadiazine	20 g in 1 TUBE	CREAM	20	1
87063-078-25	Silver Sulfadiazine	25 g in 1 TUBE	CREAM	25	1
87063-078-40	Silver Sulfadiazine	400 g in 1 JAR	CREAM	400	1
87063-078-50	Silver Sulfadiazine	50 g in 1 JAR	CREAM	50	1
87063-078-85	Silver Sulfadiazine	85 g in 1 TUBE	CREAM	85	1

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 · 15 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 ndc (product): 87063-078
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	Bryant Ranch Prepack	0084786a-09a3-4612-9afc-6733cc0cc56a	2025-02-10	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	Bryant Ranch Prepack	ede72069-2bb3-43e8-a45c-33ae3efeb922	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Bryant Ranch Prepack	d02fe8b9-2a20-40e7-8674-19768ff4d42d	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Bryant Ranch Prepack	3a04ce6d-4c38-4e21-8273-98a43d8c6359	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Bryant Ranch Prepack	b3c0884b-2f6b-4608-9cab-bef2b370bc33	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018810 application number: NDA018810
Silver Sulfadiazine	SILVER SULFADIAZINE	Bryant Ranch Prepack	3604ed05-8d91-475a-b950-2c114b3f890d	2024-08-06	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	4d9aa72e-b8dc-4ea3-be44-80f03ba81982	1
106351	silver sulfadiazine 10 MG/ML Topical Cream	SCD	4d9aa72e-b8dc-4ea3-be44-80f03ba81982	1
106351	silver sulfadiazine 1 % Topical Cream	SY	4d9aa72e-b8dc-4ea3-be44-80f03ba81982	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87063-078-05	87063007805	50 g in 1 TUBE (87063-078-05)	50 g	2026-01-23	No	No	Current
87063-078-10	87063007810	1000 g in 1 JAR (87063-078-10)	1000 g	2026-01-23	No	No	Current
87063-078-20	87063007820	20 g in 1 TUBE (87063-078-20)	20 g	2026-01-23	No	No	Current
87063-078-25	87063007825	25 g in 1 TUBE (87063-078-25)	25 g	2026-01-23	No	No	Current
87063-078-40	87063007840	400 g in 1 JAR (87063-078-40)	400 g	2026-01-23	No	No	Current
87063-078-50	87063007850	50 g in 1 JAR (87063-078-50)	50 g	2026-01-23	No	No	Current
87063-078-85	87063007885	85 g in 1 TUBE (87063-078-85)	85 g	2026-01-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Silver Sulfadiazine - Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	1