Silver Sulfadiazine

Product NDC: 61919-237
Requested package NDC: 61919-237-25
11-digit product format: 619190237
Labeler code: 61919
Product ID: 61919-237_4d3a460b-1b9a-2906-e063-6294a90a3669
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Silver Sulfadiazine
Dosage form: CREAM
Route: TOPICAL
Labeler: DIRECT RX
Application: NDA018578
Marketing category: NDA
Marketing start: 2014-01-01
Marketing end: 2027-09-30
Substance: SILVER SULFADIAZINE
Active strength: 10 g/1000g
NDC exclude flag: No
Current FDA listing: Yes

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 · 10 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018578-001	SSD	SILVER SULFADIAZINE	1%	CREAM / TOPICAL	AB	RLD, RS	1982-02-25
N018578-003	SSD AF	SILVER SULFADIAZINE	1%	CREAM / TOPICAL			1990-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018578-001	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018578-001	SSD	1%	CREAM / TOPICAL	AB	RLD, RS	1982-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018578-001	SSD	1%	CREAM / TOPICAL	AB	RLD, RS	1982-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018578-001	SSD	1%	CREAM / TOPICAL	AB	RLD, RS	1982-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018578-001	SSD	1%	CREAM / TOPICAL	AB	RLD, RS	1982-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018578-001	SSD	1%	CREAM / TOPICAL	AB	RLD, RS	1982-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018578-001	SSD	1%	CREAM / TOPICAL	AB	RLD, RS	1982-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018578-001	SSD	1%	CREAM / TOPICAL	AB	RLD, RS	1982-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018578-001	SSD	1%	CREAM / TOPICAL	AB	RLD, RS	1982-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018578-001	SSD	1%	CREAM / TOPICAL	AB	RLD, RS	1982-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018578-001	SSD	1%	CREAM / TOPICAL	AB	RLD, RS	1982-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018578-001	SSD	1%	CREAM / TOPICAL	AB	RLD, RS	1982-02-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018578-001	SSD	1%	CREAM / TOPICAL	AB	RLD, RS	1982-02-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018578-001	SSD	1%	CREAM / TOPICAL	AB	RLD, RS	1982-02-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018578-001	SSD	1%	CREAM / TOPICAL	AB	RLD, RS	1982-02-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018578-001	SSD	1%	CREAM / TOPICAL	AB		1982-02-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018578-001	SSD	1%	CREAM / TOPICAL	AB		1982-02-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018578-001	SSD	1%	CREAM / TOPICAL	AB		1982-02-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018578-001	SSD	1%	CREAM / TOPICAL	AB		1982-02-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018578-001	SSD	1%	CREAM / TOPICAL	AB		1982-02-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018578-001	SSD	1%	CREAM / TOPICAL	AB		1982-02-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018578-003	SSD AF	1%	CREAM / TOPICAL			1990-07-11	`782e0a99824c…`

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	N018578-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018578-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018578-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018578-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018578-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018578-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018578-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018578-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018578-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018578-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018578-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018578-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018578-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018578-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018578-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018578-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018578-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018578-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018578-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018578-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018578-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018578-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018578-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018578-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018578-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018578-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018578-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018578-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018578-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018578-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018578-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018578-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018578-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018578-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018578-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018578-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018578-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018578-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018578-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018578-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Silver Sulfadiazine

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SILVER SULFADIAZINE	10 g/1000g

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
7ef0cf79-e960-44a6-acac-797913b71c97	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
61919-237-25	2025-01-30	C162847	48780-1	2cef2736-b3aa-d83d-e063-dadaa90ab31f	Silver Sulfadiazine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-237-25	Silver Sulfadiazine	25 g in 1 TUBE	CREAM	25		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-237-25	GM - Gram	61919-237	741ced7f-9ecb-4f71-adf2-a50fcf2fff06	1	2024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Silver Sulfadiazine	ACTIVE INGREDIENT	W46JY43EJR	SILVER SULFADIAZINE CREAM [DIRECT RX]	1
SILVER CATION	ACTIVE MOIETY	57N7B0K90A	SILVER SULFADIAZINE CREAM [DIRECT RX]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	SILVER SULFADIAZINE CREAM [DIRECT RX]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	SILVER SULFADIAZINE CREAM [DIRECT RX]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SILVER SULFADIAZINE CREAM [DIRECT RX]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	SILVER SULFADIAZINE CREAM [DIRECT RX]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	SILVER SULFADIAZINE CREAM [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SILVER SULFADIAZINE CREAM [DIRECT RX]	1
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	SILVER SULFADIAZINE CREAM [DIRECT RX]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	SILVER SULFADIAZINE CREAM [DIRECT RX]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SILVER SULFADIAZINE CREAM [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-237	SILVER SULFADIAZINE CREAM [DIRECT RX]	4	Current NDC, Legacy NDC, 1 package rows	20230112_7ef0cf79-e960-44a6-acac-797913b71c97.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SSD Cream	SILVER SULFADIAZINE	St. Mary's Medical Park Pharmacy	24b01ac4-3ed5-db3d-e063-6394a90a0629	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018578 application number: NDA018578
Silver Sulfadiazine	SILVER SULFADIAZINE	NuCare Pharmaceuticals,Inc.	c6a40aee-ef43-e40b-e053-2995a90ae048	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018578 application number: NDA018578
Silver Sulfadiazine	SILVER SULFADIAZINE	DIRECT RX	7ef0cf79-e960-44a6-acac-797913b71c97	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018578 application number: NDA018578 ndc (package): 61919-237-25 ndc (product): 61919-237 ndc11 (package): 61919023725
SSD Cream	SILVER SULFADIAZINE	Preferred Pharmaceuticals Inc.	cb7d2adf-d69d-4686-b9cf-c83d73acc441	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018578 application number: NDA018578
SSD Cream	SILVER SULFADIAZINE	NuCare Pharmaceuticals, Inc.	37670ded-5d4a-4e98-e063-6394a90a1571	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018578 application number: NDA018578
SSD	SILVER SULFADIAZINE	A-S Medication Solutions	bf1367b4-3075-4373-8998-d9006f680df3	2024-11-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018578 application number: NDA018578
Silver Sulfadiazine	SILVER SULFADIAZINE	Asclemed USA, Inc.	bee162c3-2627-4f28-9715-11a351d497eb	2022-03-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018578 application number: NDA018578
SSD Cream	SILVER SULFADIAZINE	Dr Reddys Laboratories Inc	30d6dc33-e457-466b-9159-d8e7cd791820	2019-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018578 application number: NDA018578

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	7ef0cf79-e960-44a6-acac-797913b71c97	5
106351	silver sulfadiazine 10 MG/ML Topical Cream	SCD	7ef0cf79-e960-44a6-acac-797913b71c97	5
106351	silver sulfadiazine 1 % Topical Cream	SY	7ef0cf79-e960-44a6-acac-797913b71c97	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-237-25	61919023725	25 g in 1 TUBE (61919-237-25)	25 g	2015-01-01	2027-09-30	No	No	Current