SILVER SULFADIAZINE

Product NDC: 59762-0131
11-digit product format: 597620131
Labeler code: 59762
Product ID: 59762-0131_1d9744df-203c-419a-9aca-3ca748b09c98
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: silver sulfadiazine
Dosage form: CREAM
Route: TOPICAL
Labeler: Mylan Pharmaceuticals Inc.
Application: NDA017381
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-01-15
Substance: SILVER SULFADIAZINE
Active strength: 10 mg/g
Pharmacologic classes: Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
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
N017381-001	SILVADENE	SILVER SULFADIAZINE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017381-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017381-001	SILVADENE	1%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`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	N017381-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017381-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017381-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017381-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017381-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017381-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017381-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017381-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017381-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017381-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017381-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017381-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017381-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017381-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017381-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017381-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017381-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017381-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017381-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017381-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017381-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017381-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017381-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017381-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017381-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017381-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017381-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017381-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017381-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017381-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017381-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017381-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017381-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017381-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017381-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017381-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017381-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017381-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017381-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017381-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

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
7a6a9590-9983-46ff-ae5c-fe95f4e16cb8	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
59762-0131-0	2020-08-11	SILVER SULFADIAZINE CREAM 1%
59762-0131-2	2020-08-11	SILVER SULFADIAZINE CREAM 1%
59762-0131-4	2020-08-11	SILVER SULFADIAZINE CREAM 1%
59762-0131-5	2020-08-11	SILVER SULFADIAZINE CREAM 1%
59762-0131-6	2020-08-11	SILVER SULFADIAZINE CREAM 1%
59762-0131-8	2020-08-11	SILVER SULFADIAZINE CREAM 1%
59762-0131-0	2020-07-22	SILVER SULFADIAZINE CREAM 1%
59762-0131-2	2020-07-22	SILVER SULFADIAZINE CREAM 1%
59762-0131-4	2020-07-22	SILVER SULFADIAZINE CREAM 1%
59762-0131-5	2020-07-22	SILVER SULFADIAZINE CREAM 1%
59762-0131-6	2020-07-22	SILVER SULFADIAZINE CREAM 1%
59762-0131-8	2020-07-22	SILVER SULFADIAZINE CREAM 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59762-0131-0	SILVER SULFADIAZINE	20 g in 1 TUBE	CREAM	20	8
59762-0131-0	SILVER SULFADIAZINE	1 in 1 CARTON	CREAM	1	8
59762-0131-2	SILVER SULFADIAZINE	25 g in 1 TUBE	CREAM	25	8
59762-0131-2	SILVER SULFADIAZINE	1 in 1 CARTON	CREAM	1	8
59762-0131-4	SILVER SULFADIAZINE	400 g in 1 JAR	CREAM	400	8
59762-0131-5	SILVER SULFADIAZINE	1 in 1 CARTON	CREAM	1	8
59762-0131-5	SILVER SULFADIAZINE	50 g in 1 TUBE	CREAM	50	8
59762-0131-6	SILVER SULFADIAZINE	50 g in 1 JAR	CREAM	50	8
59762-0131-8	SILVER SULFADIAZINE	1 in 1 CARTON	CREAM	1	8
59762-0131-8	SILVER SULFADIAZINE	85 g in 1 TUBE	CREAM	85	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59762-0131-0	GM - Gram	59762-0131	9b01122f-86d6-4ac5-9df3-f5bb60e469f5	1	2018-03-08
59762-0131-2	GM - Gram	59762-0131	a746c528-76c4-4423-ac0a-776e65607872	1	2018-03-08
59762-0131-4	GM - Gram	59762-0131	c58791ce-44b7-4f6e-8019-8b5d3efe229d	1	2018-02-20
59762-0131-5	GM - Gram	59762-0131	9300dca7-695a-4eac-976f-a2f06d185904	1	2018-02-20
59762-0131-6	GM - Gram	59762-0131	24fe45a0-a1b0-4cb9-9065-92edc9ddfded	1	2018-02-20
59762-0131-8	GM - Gram	59762-0131	0b3e4977-02d8-4514-927b-151df8a426a2	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59762-0131	SILVER SULFADIAZINE CREAM [MYLAN PHARMACEUTICALS INC.]	7	Current NDC, Legacy NDC, 10 package rows	20250528_7a6a9590-9983-46ff-ae5c-fe95f4e16cb8.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SILVADENE	SILVER SULFADIAZINE	Pfizer Laboratories Div Pfizer Inc	c437213a-1cd4-445e-a39f-bbcacb9f746f	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017381 application number: NDA017381
SILVER SULFADIAZINE	SILVER SULFADIAZINE	Mylan Pharmaceuticals Inc.	7a6a9590-9983-46ff-ae5c-fe95f4e16cb8	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017381 application number: NDA017381 ndc (product): 59762-0131
SILVADENE	SILVER SULFADIAZINE	A-S Medication Solutions	54b77a36-205b-4044-9ecb-c5130f0934b5	2023-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017381 application number: NDA017381

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	7a6a9590-9983-46ff-ae5c-fe95f4e16cb8	8
106351	silver sulfadiazine 10 MG/ML Topical Cream	SCD	7a6a9590-9983-46ff-ae5c-fe95f4e16cb8	8
106351	silver sulfadiazine 1 % Topical Cream	SY	7a6a9590-9983-46ff-ae5c-fe95f4e16cb8	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59762-0131-0	59762013100	1 TUBE in 1 CARTON (59762-0131-0) / 20 g in 1 TUBE	1 tube	2018-02-09	0000-00-00	No	No	Current
59762-0131-2	59762013102	1 TUBE in 1 CARTON (59762-0131-2) / 25 g in 1 TUBE	1 tube	2018-02-09	0000-00-00	No	No	Current
59762-0131-4	59762013104	400 g in 1 JAR (59762-0131-4)	400 g	2018-01-16	0000-00-00	No	No	Current
59762-0131-5	59762013105	1 TUBE in 1 CARTON (59762-0131-5) / 50 g in 1 TUBE	1 tube	2018-01-16	0000-00-00	No	No	Current
59762-0131-6	59762013106	50 g in 1 JAR (59762-0131-6)	50 g	2018-01-16	0000-00-00	No	No	Current
59762-0131-8	59762013108	1 TUBE in 1 CARTON (59762-0131-8) / 85 g in 1 TUBE	1 tube	2018-01-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SILVER SULFADIAZINE CREAM 1%	Mylan Pharmaceuticals Inc. \| Pfizer Inc \| Pharmacia & Upjohn Company LLC	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	8