SSD Cream

Product NDC: 55700-640
11-digit product format: 557000640
Labeler code: 55700
Product ID: 55700-640_a216165c-73ae-483d-a43f-423928c5e25e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Silver Sulfadiazine
Dosage form: CREAM
Route: TOPICAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: NDA018578
Marketing category: NDA
Marketing start: 2018-06-15
Marketing end: 0000-00-00
Substance: SILVER SULFADIAZINE
Active strength: 10 g/1000g
Pharmacologic classes: Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	55700-640		D	Discontinued by firm		2026-08-11
excluded package	package	55700-640	55700-640-50	D	Discontinued by firm		2026-08-11

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	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-640-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-640-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-640-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-640-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-640-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-640-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-640-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-640-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-640-50	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-640-50	GM - Gram	55700-640	884f9c4d-97aa-428d-87ab-65a04a354bbf	1	2018-07-03

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-640-50	55700064050	50 g in 1 TUBE (55700-640-50)	50 g	2018-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SSD™ (1% Silver Sulfadiazine Cream) SSD AF™ (1% Silver Sulfadiazine Cream)	Lake Erie Medical DBA Quality Care Products LLC	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	4